Resources Sector: Laboratories

IVDR Lab Readiness: Step-by-Step Transition Checklist

January 28, 2026
Experienced healthcare professional in MedTech innovation promoting digital health solutions and medical device advancements for improved patient outcomes.

Hugo Leis Martinez

The IVDR Shift and What It Means for Clinical Laboratories

The in Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 came into force on 26 May 2022, representing a paradigm shift for diagnostic testing in Europe. Its purpose is clear: ensure safety, traceability, and performance of all in vitro diagnostic devices (IVDs). Unlike its predecessor, the IVDD (98/79/EC), the IVDR applies far-reaching obligations not only to manufacturers but also to clinical laboratories that develop and use their own in-house IVDs (IH-IVDs).

A cornerstone of this new landscape is Article 5(5), which sets conditions under which health institutions may continue manufacturing and using in-house devices without CE marking. While this exemption acknowledges the clinical need for tailored diagnostics, it also imposes new responsibilities.

This blog provides a step-by-step readiness checklist for laboratories to guide you through the transition.

Step 1: Do You Know What Counts as an In-House IVD?

What exactly is an in-house IVD under the IVDR?

An in-house IVD (sometimes called a laboratory-developed test or LDT) is any in vitro diagnostic device manufactured and used only within a health institution, not supplied to another legal entity, and not manufactured on an industrial scale

Examples include:

  • PCR assays where the lab develops its own probes.
  • Custom-developed software tools for diagnostic interpretation.

Excluded are:

  • General laboratory supplies.
  • RUO (research use only) products – unless repurposed for diagnostic use. If an RUO product is used for diagnostic purposes (i.e., results are communicated to the patient for medical decision-making), it ceases to be RUO and must comply with IVDR Article 5(5), thereby becoming subject to the same obligations as an in-house IVD/LDT.
  • Commercially available CE-marked IVDs (which must be purchased and used as intended) – unless it is modified, combined or used outside it’s intended purpose.

Takeaway:

You must determine whether you are using an in-house IVD. If you are modifying, combining, or using CE-marked diagnostic tests outside their intended purpose, or if you are repurposing RUO products for diagnostic use, you must ensure compliance with Article 5(5).

Step 2: Is Your Laboratory Recognized as a Health Institution?

Who is entitled to the Article 5(5) exemption?

Only health institutions may use in-house IVDs. According to the IVDR, a health institution is an organization whose primary purpose is patient care or public health. This includes:

  • Hospitals
  • Clinical laboratories
  • Public health institutes

Importantly, the recognition of health institutions may depend on national legislation. For instance, some countries require formal registration or accreditation to benefit from Article 5(5).

Takeaway:

Always check your national laws to confirm whether your laboratory qualifies as a “health institution” and whether additional national restrictions or obligations apply.

Step 3: CE-Marked or In-House? Make a Strategic Choice

Should your lab buy CE-marked tests or continue with in-house ones?

Under IVDR, labs face a strategic decision:

  • Purchase CE-marked IVDs: These carry regulatory assurance but may not always exist for niche diagnostic needs, and market withdrawals could limit supply.
  • Develop and use in-house IVDs: Allowed under Article 5(5) if your lab demonstrates compliance with conditions (e.g., GSPR, QMS, technical documentation).

From 31 December 2030, labs must justify why an equivalent CE-marked device is not suitable if they want to continue using their in-house test (article 5(5)(g))

Takeaway:

Begin analyzing your portfolio now. Which tests could be replaced by CE-IVDs, and which must remain in-house due to clinical need?

Step 4: Do You Comply with General Safety and Performance Requirements (GSPR)?

What technical documentation requirements already apply?

Since 26 May 2022, all in-house devices must comply with Annex I of the IVDR (GSPR). This includes:

  • Risk management system covering patient, user, and use error risks.
  • Performance evaluation based on scientific validity, analytical performance, and clinical performance.
  • Traceability and identification (lot numbers, production dates).
  • Appropriate instructions for use and safety information

Takeaway:

Treat your in-house tests with the same rigor as CE-marked devices. Maintain documentation to always prove compliance with the GSPRs.

Step 5: Have You Implemented an Appropriate QMS?

What does IVDR require for quality management when operating under article 5.5?

Since 26 May 2024, labs must manufacture and use in-house devices under an appropriate Quality Management System (QMS). For in-house IVDs, this generally means compliance with EN ISO 15189 or equivalent national provisions

However, note:

  • ISO 15189 covers quality in medical laboratories but not necessarily manufacturing processes.
  • Therefore, supplement with elements of ISO 13485 for design and production control.
  • In addition, laboratories must address the QMS requirements described in Article 10(8) IVDR, which outline the minimal aspects of a system covering risk management, manufacturing documentation, monitoring, corrective actions, and communication with authorities.

Takeaway:

Expand your QMS to cover risk management, manufacturing documentation, monitoring, and corrective actions, and the additional QMS obligations set out in Article 10 IVDR. Note that ISO 15189 alone is not sufficient; relevant elements of design and manufacturing from ISO 13485 must also be considered, as the IVDR introduces further QMS requirements that must be fulfilled.

Step 6: Can You Provide a Public Declaration?

Do labs need to publish information about their in-house devices?

Article 5(5)(f) IVDR requires health institutions to draw up and make publicly available a declaration for each in-house device. This obligation has applied since 26 May 2024, following the end of the initial transition period.

What must the declaration contain? At minimum:

  • Name and address of the health institution manufacturing the device.
  • Details necessary to identify the device (e.g., designation, type, internal code).
  • A declaration of compliance with Annex I (GSPR), or where full compliance is not possible, a reasoned justification explaining the deviations.
  • Confirmation that the device is manufactured under an appropriate QMS.

This declaration must be kept up to date and made easily accessible, typically via the laboratory or hospital’s website This transparency ensures accountability and facilitates oversight.

Takeaway:

Prepare standardized declarations for each in-house device. A practical tool exists: the IVDR Taskforce Guidance on LDTs (2020) provides a template (Appendix B) for the declaration that can be directly adapted by laboratories.

Step 7: Are You Ready for Competent Authority Oversight?

What role do regulators play?

Competent authorities may request documentation or even audit your lab to verify compliance. Labs must be prepared to show:

  • Design, manufacturing, and performance documentation of their in-house devices.
  • Clinical justification for developing or using the test instead of a CE-marked alternative.
  • Ongoing performance review and vigilance records, including corrective actions and monitoring of clinical use.
  • Evidence of an appropriate Quality Management System (QMS), as required since 26 May 2024.

The degree of oversight varies across Member States. For example, Belgium and Ireland already operate registration portals where laboratories must register their in-house tests. In other countries, legislation is still under development (Spain) or practices remain vague.

Takeaway:

Anticipate audits. Keep a compliance file for each in-house IVD.

Step 8: How Will You Justify Non-Equivalence? (2030 Requirement)

What happens in 2030?

From 31 December 2030, labs must justify why the specific needs of their target patient group cannot be met by a CE-marked device – Article 5(5)(g).

This justification may be based on:

  • Technical aspects (e.g., higher sensitivity).
  • Biological aspects (e.g., pediatric vs adult reference ranges).
  • Clinical needs (e.g., unmet diagnostic gaps).

Takeaway:

Start now by mapping your portfolio and identifying tests likely to face challenges in proving non-equivalence.

Step 9: Do You Have the Resources?

Why are many labs struggling?

Challenges highlighted in recent analyses include:

  • Lack of dedicated regulatory staff.
  • Limited time and budget for documentation.
  • Unfamiliarity with regulatory terminology.

Takeaway:

Seek structured support, whether through consultants, digital tools, or peer networks, to avoid non-compliance.

Step 10: Checklist. Is Your Lab Ready?

Step 1: Perform a GAP Assessment

  • Map your current situation: List all in-house IVDs and how they are used in your lab.
  • Check national status: Verify if your institution qualifies as a “health institution” under national law, and review whether national legislation imposes additional obligations such as mandatory QMS accreditation (e.g., ISO 15189), registration of in-house IVDs with competent authorities, or other reporting requirements that go beyond the IVDR.
  • Compare requirements vs. practice: Review the IVDR Article 5(5) obligations and identify where your lab already complies (e.g., risk management, traceability) and where gaps exist (e.g., QMS documentation, technical documentation).
  • Prioritize risks: Highlight critical areas (such as missing QMS procedures or incomplete Annex I documentation) that could block compliance in an inspection.

Step 2 – Take Action to Close the Gaps

  • Strategic choice: Decide whether to replace tests with CE-IVDs or maintain in-house versions. Document the rationale.
  • Annex I (GSPR): Ensure all in-house IVDs comply with General Safety and Performance Requirements (effective since 26 May 2022).
  • Quality Management System: Implement or update your QMS to align with ISO 15189, supplemented with elements from ISO 13485 and Article 10(8) IVDR.
  • Compliance documentation & oversight readiness: Compile and maintain a compliance file for each in-house IVD, including full technical documentation (design, manufacturing, risk management, and performance evaluation). Ensure these files are audit-read and can be provided upon request by competent authorities.
  • Vigilance & corrective actions: Set up procedures for monitoring performance, handling incidents, and implementing corrective/preventive measures.
  • Public declaration: Draft and publish a declaration for each in-house device (mandatory since 26 May 2024). Use available templates from guidance.
  • 2030 justification: Start documenting why no equivalent CE-IVD meets the needs of your patient population to support continued in-house use after 31 December 2030.

Closing Thoughts

The IVDR sets high expectations for laboratory-developed in-house IVDs, transforming informal diagnostic practices into rigorously controlled processes. While compliance requires effort, resources, and cultural change, it also strengthens quality, safety, and patient trust. For laboratories, the transition is not optional, it is an opportunity to embed regulatory excellence into daily operations and secure the future of innovative diagnostics. Are you ready for the IVDR transition? Start today with a gap analysis, QMS reinforcement, and documentation plan. The earlier you act, the smoother your path to compliance will be.

At MDx CRO, we specialize in helping clinical laboratories navigate the IVDR, from gap assessments to QMS implementation and technical documentation. We support laboratories in demonstrating compliance with Article 5(5) for in-house IVDs by assisting with:

  • Gap assessments: Mapping all in-house IVDs, comparing current practice with IVDR Article 5(5) requirements, and identifying compliance gaps.
  • QMS alignment: Extending ISO 15189-based systems with manufacturing and design elements from ISO 13485, plus additional QMS obligations under IVDR.
  • Technical documentation: Preparing complete compliance files per device.
  • Public declarations: Drafting and publishing Article 5(5)(f) declarations using recognized templates, ensuring accessibility and consistency.
  • Regulatory readiness: Preparing for competent authority oversight, including audits and requests for documentation.
  • Strategic portfolio decisions: Advising whether to replace tests with CE-IVDs or justify continued in-house use, including preparing 2030 equivalence justifications.
  • Vigilance systems: Setting up monitoring, incident reporting, and corrective/preventive actions in line with IVDR obligations.

Our team knows the pitfalls and the solutions. Let us support you in achieving full compliance. Contact us today to discuss how we can help.

Written by:
Hugo Leis, PhD

Hugo Leis, PhD

Training & Quality Manager

Quality & Training Manager and Senior IVDR consultant with expertise in CE marking, Clinical Laboratories, SaMD, Precision Medicine, Quality Assurance, and academic lecturing.
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Spanish IVD Regulation 2025 – New Royal Decree Updates for IVD Manufacturers, Sponsors, and Labs

October 21, 2025

On 21 October 2025, the Council of Ministers approved Spain’s new Royal Decree for in vitro diagnostic devices. AEMPS confirmed the approval and explained that the decree complements IVDR (EU) 2017/746, strengthens patient protection, and adds national rules on language, in-house manufacturing, performance studies, and vigilance. This development anchors the Spanish IVD Regulation 2025 and sets clear obligations for manufacturers, sponsors, and laboratories. (Official announcement: AEMPS)

Spanish IVD Regulation 2025: What Changed and Why It Matters

The Spanish IVD Regulation 2025 replaces Royal Decree 1662/2000. It clarifies how IVDR applies in Spain and fills Member-State choices, including competent authority, language regime, Article 5(5) in-house devices, genetic testing and counseling, a national marketing register, performance study authorization, and vigilance and market control.

The regulation aims to raise quality, ensure traceability, and speed up corrective actions. It also improves access to certain self-tests through pharmacy channels.

Quick Guide for Busy Teams (Manufacturers, Sponsors, Labs)

  • Confirm what the Spanish IVD Regulation 2025 changes for your role.
  • Map licensing, registration, language, Article 5(5), ISO 15189, performance studies, and vigilance to owners and deadlines.
  • Prepare Spanish-language materials and set up traceability and incident reporting workflows.
  • Labs should plan ISO 15189 and Article 5(5) notifications to AEMPS.

Competent Authority and Language Rules under the Spanish IVD Regulation 2025

AEMPS is the competent authority for IVDs in Spain. Under the Spanish IVD Regulation 2025, user-facing materials for devices marketed in Spain must appear in Spanish. That includes labels, IFU, and safety notices. Regulatory submissions to AEMPS should include Spanish content. Co-official languages may be added, but Spanish is mandatory.

Action: Audit labeling, IFU, FSNs, PMS templates, and performance study files. Plan translations and version control.

Facility Licensing: Manufacturers, Sterilizers, and Importers

The Spanish IVD Regulation 2025 requires operating licenses for manufacturers, sterilizers, and importers before they place devices on the market. AEMPS evaluates facilities, personnel, and quality systems.

Each site must appoint a Technical Responsible Person (national role) and meet IVDR oversight led by a PRRC. One qualified person can cover both if they meet the criteria.

Transitional rule: Existing third-party manufacturers get up to one year from entry into force to secure the new license. Existing licenses remain valid until renewal or change, which then follow the new procedure.

Action: Confirm license status, designate the responsible person, and prepare for renewal under the new framework.

Marketing Register and Traceability

The decree creates a Spanish marketing register for devices placed on the market. Manufacturers, authorized representatives, and importers must notify product information to support traceability and market surveillance. The register complements EUDAMED and UDI.

Transitional rule: Spain will activate notifications when the register is operational. Until then, use existing national channels.

Action: Build a clean data set for device identifiers, certificates, and supply chains. Prepare to submit once AEMPS opens the register.

In-House Devices (Article 5(5) IVDR): What Labs Must Do Now

Scope and intent

The Spanish IVD Regulation 2025 regulates in-house IVDs made and used within the same health institution. Labs must justify need: a commercial CE-marked device cannot meet the specific clinical need. No industrial-scale production. No commercial supply to third parties.

Quality and documentation

In-house devices must meet IVDR GSPRs. Labs should keep a technical file (intended purpose, risk management, analytical and clinical performance, V&V, SOPs, and labeling for internal use).

ISO 15189 accreditation

Labs that manufacture in-house devices must obtain ISO 15189 accreditation for the manufacturing scope. Spain ties this to the transitional schedule.

Notification to AEMPS

Before starting in-house manufacture, labs must notify AEMPS and submit the Article 5(5) declaration. They must designate a responsible person for the in-house manufacturing process.

Action for labs: Launch ISO 15189 projects, finalize Article 5(5) templates, and prepare the AEMPS notification package.

Genetic Testing: Information and Counseling

The Spanish IVD Regulation 2025 requires clear information and appropriate counseling for genetic testing. Health professionals must explain limits, implications, and result interpretation. This duty applies before and after testing.

Health professionals and centers must obtain explicit informed consent from individuals before performing a genetic test. The patient must be made aware of the nature and purpose of the test and consent in writing (except where law may exempt certain public health screening). This goes beyond standard consent, recognizing the personal and familial implications of genetic data.

Before the test, patients should be informed about what the test can and cannot tell them, and after the test, a qualified professional should explain the results and any recommended follow-up. This requirement ensures genetic tests (such as those for hereditary disease risk) are not delivered without context or support, helping patients make informed decisions.

These obligations apply to genetic IVDs regardless of whether they are done in-house or as commercial tests. For example, a direct-to-consumer genetic test kit (if allowed on the market) would need to be accompanied by processes that ensure the purchaser gets necessary information and counseling. However, most genetic tests are administered in clinical settings; the decree effectively standardizes the practice of genetic counseling as part of testing.

Action: Update consent forms, patient information sheets, and SOPs for genetic counseling, including training for staff.

Performance Studies in Spain

All performance studies in Spain must first obtain a favorable opinion from an accredited Research Ethics Committee (REC) and authorization from the health center’s management where the study will be conducted. This applies to any study using human specimens or data for evaluating an IVD’s performance, ensuring ethical considerations (informed consent, data protection, etc.) are addressed early.

When you need authorization

Interventional clinical performance studies and other studies involving risks require AEMPS authorization before first participant. Ethics approval remains mandatory.

What sponsors must prepare

  • Spanish protocol (CPSP), Investigator’s Brochure, and informed consent.
  • Insurance/indemnity for participants and a clear liability framework. The decree explicitly requires compensation for damages and defines the liability regime for sponsors. Sponsors should budget for a clinical trial insurance policy and follow the decree’s rules on coverage minimums and conditions (similar to drug trial insurance requirements in Spain).
  • Monitoring, data management, and safety reporting plans aligned with IVDR. Upon study completion, results (whether positive, negative, or inconclusive) should be documented and may need to be reported in the public database or to AEMPS.

Studies with CE-marked devices

If the study adds invasive or burdensome procedures or goes outside intended use, sponsors should request authorization and notify AEMPS.

Action for sponsors: Build a Spain-ready dossier, confirm insurance, and align timelines with AEMPS and ethics reviews.

Vigilance and Market Control

The Spanish IVD Regulation 2025 reinforces vigilance. Manufacturers must report serious incidents and FSCAs to AEMPS. Healthcare professionals and institutions should also report incidents. Authorities will coordinate inspections and market control actions.

For instance, if an IVD test yields false results that lead to patient harm, the manufacturer has to notify AEMPS and submit a Spanish-language safety notice so that users in Spain can be adequately informed. This ensures critical safety information is effectively communicated and mitigated in the local context.

The decree emphasizes that healthcare professionals, health institutions, and even patients/users have a responsibility to report any suspected serious incidents to AEMPS. Spain is thus bolstering a culture of vigilance: a lab that encounters a device malfunction or a clinician who notices a pattern of erroneous results should alert the authorities. The more comprehensive the reporting, the better AEMPS can intervene to prevent harm.

Action: Maintain robust PMS plans, trend analysis, Spanish FSNs, and clear internal reporting lines. Hospitals should assign a vigilance lead and train teams.

Self-Test Access and Pharmacy Channels

Notably, the new rules remove the prescription requirement for at-home self-testing kits (e.g. self-tests for glucose, pregnancy, COVID-19, etc.), making them more accessible. However, even without needing a prescription, these self-diagnostic products can only be sold through pharmacies (in-store or via an official pharmacy website) to ensure proper guidance on use. High-risk tests or those used for critical decisions may still require a prescription or professional administration.

Action: Manufacturers should confirm packaging, leaflets, and e-commerce pharmacy guidance in Spanish.

Transitional Timelines You Should Track

  • Entry into force: The decree takes effect after BOE publication.
  • Licensing: Existing third-party manufacturers have up to one year to obtain the new operating license.
  • Marketing register: Notification duties start when the register goes live.
  • In-house devices: Spain applies the IVDR timelines. Labs must meet Article 5(5) conditions and ISO 15189 by the dates set in the transitional provisions and related guidance.
  • Legacy devices: Spain honors the IVDR transition for legacy IVDs and preserves specific old-rule processes until systems fully switch over.

Action: Put a dated compliance tracker in place for licensing, Article 5(5), ISO 15189, registry readiness, and vigilance.

Implications by Stakeholder

IVD manufacturers

  • Secure or update operating licenses.
  • Localize labels/IFU into Spanish.
  • Prepare marketing register data.
  • Strengthen PMS and vigilance interfaces with AEMPS.

Sponsors

  • Plan authorization for risk-involving performance studies.
  • Build Spain-ready dossiers and insurance.
  • Prepare Spanish IB, consent forms, and patient materials. Note: AEMPS may allow an english version of the IB if no objection is raised by the Ethics Committee.

Hospital and private labs

  • Confirm Article 5(5) eligibility and prepare technical documentation for the in-house test.
  • Achieve ISO 15189 for manufacturing scope.
  • Notify AEMPS and assign the in-house responsible person.
  • Update genetic testing consent and counseling SOPs.

How MDx CRO Helps You Execute

Regulatory strategy and submissions

We align IVDR with the Spanish IVD Regulation 2025 and prepare AEMPS submissions (licenses, notifications, marketing register onboarding when live).

ISO 15189 and Article 5(5)

We run gap assessments, build SOPs, and guide labs to ISO 15189 accreditation for in-house manufacture. We prepare the Article 5(5) declaration and AEMPS notification package.

Performance studies

We plan and manage interventional and risk-involving performance studies in Spain. We handle AEMPS authorization, ethics submissions, monitoring, and safety reporting. MDx can also act your IVD performance study legal representative in the EU.

Vigilance and PMS

We design Spanish-compliant PMS frameworks, incident workflows, and FSNs. We help you interface with AEMPS and prepare for inspections.

Contact MDx CRO

Written by:
David Tomé

David Tomé

President

Clinical research leader and MedTech entrepreneur with deep expertise in medical devices, IVDs & precision medicine, with global study experience.
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MDx CRO at ESMO 2025 (Berlin): Advancing IVDR Transitions & Combined Clinical Trials

October 20, 2025

MDx CRO presented new evidence and hands‑on learnings at ESMO 2025 that reinforce our position as the partner of choice for IVDR transitions and combined clinical trials involving investigational IVDs. We were first author on a poster with Fulgent Genetics and contributors to a Servier poster—both centered on the operational and regulatory realities of bringing high‑impact oncology diagnostics into clinical practice under the EU IVDR.

Highlights from our ESMO 2025 posters

Fulgent Genetics & MDx CRO — MDx CRO first author

Title: IVDR Compliance Challenges in Certifying a Large‑Scale NGS Panel for Hereditary Cancer

What it covers:

  • Practical blueprint for transitioning a comprehensive, service‑based NGS hereditary cancer panel under IVDR.
  • Defining intended use and scientific validity across a large gene set; end‑to‑end technical documentation; bioinformatics validation aligned to IEC 62304/82304; and notified‑body engagement strategy.
  • Lessons on right‑sizing verification/validation and building a living evidence package to support CE‑marking.

Why it matters: Sponsors and lab developers gain an actionable path for moving complex NGS services to IVDR compliance—without slowing clinical programs.

MDx CRO at ESMO 2025 in Berlin presenting a poster on IVDR compliance for NGS large panels for germline disease testing with Fulgent Genetics
Dr. Marketa Svobodova, Precision Medicine Director & Carlos Galamba, CEO at MDx – Poster presentation at ESMO 2025 in Berlin

Servier & MDx CRO (CHONQUER study) — MDx CRO contributor

Title: Navigating Regulatory Complexity in Combined Studies under CTR and IVDR (CHONQUER)

What it covers:

  • How combined trials (drug + investigational IVD) trigger dual oversight under CTR and IVDR and the knock‑on effects for timelines, submissions, and site activation across EU member states.
  • Operational patterns that accelerate approvals: early CPS planning, consolidated documentation, and aligned ethics/competent authority strategies.

Why it matters: Oncology sponsors can de‑risk global programs by anticipating IVDR‑specific requirements—and partnering with an IVD CRO that has worked both sides of the fence.

MDx CRO presented a poster at ESMO 2025 (Berlin) on combined CTR + IVDR clinical studies with Servier.
Dr. Marketa Svobodova, Precision Medicine Director at MDx – poster presentation at ESMO 2025 – CHONQUER study, a combined study under IVDR/CTR

Key takeaways for sponsors

  • IVDR transitions—end to end. MDx CRO supports dossier strategy, clinical performance studies (ISO 20916), scientific validity, and notified‑body engagement for CE‑marking.
  • Combined trials, simplified. We design and run CPS and combined CTR + IVDR studies, harmonizing submissions across multi‑country portfolios.
  • Oncology‑ready operations. Deep experience with molecular prescreening, NGS workflows, and drug–device coordination for precision oncology.

Need a quick debrief? Contact our IVD CRO team for a walkthrough of how these findings translate to your IVDR transition or combined study plan.

FAQs

What does MDx CRO do for IVDR transitions?

We provide end‑to‑end support—from intended‑use definition and scientific validity to clinical performance studies, technical documentation, and notified‑body engagement.

How does MDx CRO support combined CTR + IVDR studies?

We plan and execute CPS and combined trials, consolidating submissions and aligning ethics/competent authority requirements to reduce delays.

Can MDx CRO help with NGS panel validation under IVDR?

Yes. We design right‑sized verification/validation programs and bioinformatics validation aligned with IEC 62304/82304.

Where can I get the ESMO 2025 posters?

Both PDFs are available at the ESMO platform; contact us for a guided readout.

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MDx to Present ESMO 2025 Poster on IVDR CE Marking for Large Germline NGS Panels

October 7, 2025

Announcement

MDx will present a peer-reviewed poster at the ESMO Congress 2025 in Berlin detailing how our team helped secure IVDR CE marking for a large, service-based germline NGS solution that integrates wet-lab workflows with a validated bioinformatics pipeline. The poster distills a practical, audit-proven pathway that labs and IVD developers can apply when scaling evidence, validating software, and navigating notified-body reviews for complex NGS offerings.

What the poster covers

  • Regulatory strategy and intended use: How to right-size scope for very large panels while planning for future expansion.
  • Technical documentation: Building Annex II/III files that stand up to Stage I/II audits, including labeling/IFU for service-based models.
  • Software validation: Applying IEC 62304/82304 rigor to a bioinformatics pipeline (architecture, V&V, cybersecurity, change control).
  • Evidence at scale: A tiered approach to scientific validity and clinical performance, plus a pragmatic PMPF plan to mature low-prevalence evidence.
  • Operationalization: Supplier controls, change management, and QMS integration to sustain post-market scalability.
Fulgent and MDx ESMO 2025 poster about Certifying Large-Scale NGS panels for hereditary cancer

Why this matters

Large NGS panels pose unique IVDR hurdles: non-uniform clinical evidence across thousands of genes, evolving variant knowledge, third-party components without CE marking, and the need to validate bioinformatics as SaMD. By sharing a repeatable pathway and the pitfalls we overcame, this poster offers concrete guidance to shorten timelines without compromising quality or compliance.

When and where to find us

ESMO Congress 2025 takes place 17–21 October in Berlin, Germany. We will publish our poster board number and presentation time here as soon as the session logistics are confirmed by the organizers. If you’re attending, we’d love to meet to discuss your IVDR roadmap.

Read the background

For context on the underlying program and its market impact, explore the public write-ups:

Ready to talk IVDR CE marking for your NGS product?

Use our contact form to request a 30-minute slot with our regulatory and bioinformatics leads during ESMO 2025, or schedule a virtual follow-up the week after the congress.

Contact us to request a free consultation
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IVDR CE marking NGS: MDx Case Study with Fulgent

October 7, 2025

Case Study: How MDx Helped Fulgent Genetics Achieve CE Marking for One of the World’s Largest Germline NGS Panels under IVDR

IVDR CE marking NGS at a glance

  • Outcome: CE mark granted by TÜV SÜD for an end-to-end Class C germline NGS solution (wet lab + bioinformatics).
  • Scope: Furthermore, panel covering 4,600+ clinically relevant genes with a validated PLM (Pipeline Manager) software component; later expanded to >7,000 genes using a new probe set.
  • What we did: Specifically, we built an ISO 13485 QMS from the ground up, prepared full Annex II + III technical documentation, validated bioinformatics under IEC 62304/82304, split documentation into two Basic UDI-DIs (wet lab vs. software), and guided Stage I/II audits.
  • Why it matters: Ultimately, this demonstrates a repeatable pathway to IVDR certification for large NGS services and software, something that hadno clear precedent.

Read the announcements: For details, read the Fulgent press release and Citeline case study.

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Genes Certified

Class C

IVDR Classification

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Post-Cert Scale

The challenge: certifying a service-based, large-scale NGS system under IVDR

To begin with, FulgentExome is a service-based NGS solution that integrates wet-lab workflows with the Fulgent PLM bioinformatics pipeline. As a result, pursuing IVDR certification meant converting a mature CLIA/CAP testing service into a CE-marked IVD system with robust evidence across scientific validity, analytical performance, and clinical performance, for thousands of genes. In particular, key hurdles included: defining intended use at scale; validating third-party components; proving scientific validity across 4,600+ genes; above all fully validating the bioinformatics pipeline under medical device software standards.

MDx approach: a playbook for complex NGS + software

1) Build the right QMS, fast

First, we performed an IVDR GAP assessment. Next, we designed and implemented an ISO 13485-compliant QMS with risk management, supplier control, document control, internal audits, and management review—migrating from a CLIA/CAP model to IVDR-ready operations.

2) Engineer a defensible intended use

Meanwhile, the intended-use statement evolved iteratively, from an initial ~300-gene scope to whole-exome, finally landing on 4,600+ genes aligned to available clinical and analytical evidence. In the end, the final language was future-proofed to support rapid updates as evidence expands.

3) Split wet lab and software into two regulated products

Afterward, following round 1 review feedback, we separated the documentation into two Basic UDI-DIs, FulgentExome (wet lab) and Fulgent PLM (software) to align with IVDR expectations for traceability and lifecycle control. Consequently, this restructuring sharpened conformity assessment and accelerated subsequent approvals.

4) Validate the informatics stack like a medical device

In parallel, we validated PLM under IEC 62304/82304, including architecture, version control, cybersecurity, verification/validation, and integration with external databases. Therefore, the result was a fully evidence-backed bioinformatics pipeline capable of reproducible, high-confidence variant calling and reporting.

5) Make “evidence at scale” practical

  • First, Scientific validity: Three-tier strategy combining validation of exome sequencing as an approach, reliance on curated public databases, and deep exemplars for a large subset of genes.
  • Second, Clinical performance: Leveraged routine testing experience (thousands of positives) to focus clinical evidence on high-prevalence genes, and instituted a robust PMPF strategy to continuously strengthen low-prevalence areas.

6) Orchestrate TÜV SÜD audits to success

  • Initially, Stage I confirmed documentation readiness, scope, Basic UDI-DIs and integration of IVDR processes into daily practice.
  • Subsequently, Stage II verified on-the-floor implementation of SOPs, training, competence, CAPA and change control—closing findings on short cycles to hit NB timelines.

Results that move the market

  • CE mark granted for FulgentExome & Fulgent PLM, among the first end-to-end Class C germline NGS solutions under IVDR.
  • Certified scope covers 4,600+ genes, positioning Fulgent as a reference lab for comprehensive hereditary disease testing serving European patients.
  • Post-certification, the platform scaled to >7,000 genes using a new probe set, demonstrating the inherent scalability built into the certified system (process, documentation, and change control).
  • Strengthened competitive standing in the EU diagnostics market; public communications highlight the magnitude of this achievement for large NGS panels.

Read more in the Fulgent press release and Citeline’s in-depth article.

What this means for labs and IVD developers planning large NGS submissions

If you operate an LDT today: you’ll need to translate CLIA/15189 practices into an ISO 13485 framework, document design controls, and produce a full PER (PEP/PER), APR, SVR, PMS/PMPF, SSP, and labeling/IFU aligned to GSPR. Expect to validate any bioinformatics pipeline as SaMD with IEC 62304/82304 and cybersecurity controls.

If your panel is “large”: you likely won’t have uniform clinical data across every gene. A structured tiered evidence model + PMPF can satisfy Notified Bodies while keeping your roadmap scalable.

If you combine wet lab + software: plan for separate Basic UDI-DIs and documentation sets. Treat the pipeline as a product with its own requirements, verification, and risk controls.

Why MDx

  • End-to-end IVDR expertise: From regulatory strategy & classification to Annex II/III technical files, PER/SVR/APR, training, and mock NB reviews. Read more about our NGS regulatory services.
  • Clinical performance studies: We design, run, and report ISO 20916 studies (protocols, eTMF, monitoring, biostats, PER alignment), and we can act as delegated sponsor for multi-country submissions—100% submission success rate to date.
  • Operational scale: ISO 9001 clinical QMS, EU/US partner network, multilingual CRAs, and a repeatable process honed on 60+ performance study submissions for top IVD and pharma clients.

Project timeline

Our joint project with Fulgent spanned July 2023–July 2025, with overlapping tracks for QMS creation, technical documentation, NB review, and Stage I/II audits, a coordinated plan that allowed rapid closure of findings and post-certification scaling.

Client perspective

The program demanded evening/weekend execution across regulatory, documentation, and project management to meet Notified Body timelines, effort that, in the client’s words, “made all the difference” in achieving what initially “seemed almost impossible.”

Planning IVDR for your NGS panel? Here’s a quick readiness checklist

  • Intended use aligned to evidence (and future updates)
  • ISO 13485 QMS with software lifecycle integration
  • PER (PEP/PER), SVR, APR mapped to gene-level strategy
  • PLM/DR pipeline validated per IEC 62304/82304 (+cybersecurity)
  • Separate documentation/UDI for wet lab vs. software (if applicable)
  • PMS/PMPF plan to mature low-prevalence evidence post-market
  • Mock NB review + Stage I/II audit readiness

(Our team can lead or co-author each artifact above.)

Talk to us

Whether you’re certifying a focused oncology panel or pushing the limits with exome-scale content, MDx brings the cross-functional regulatory, clinical, quality, and software depth to make it possible—on a timeline that keeps your business competitive.

Let's discuss your IVDR roadmap

How long does IVDR CE marking take for an NGS panel?

For a large, complex NGS panel (thousands of genes, wet lab + bioinformatics software), expect 18 to 24 months from project kickoff to CE mark, assuming you need to build a QMS from scratch. If you already have an ISO 13485-certified QMS and partial technical documentation, the timeline can shorten to 12 to 16 months. The main variables are: the scope of the panel (more genes = more validation work), whether the bioinformatics pipeline needs IEC 62304 validation from zero, Notified Body capacity and review cycles, and the maturity of your clinical evidence. In the Fulgent case, the full project spanned 24 months (July 2023 to July 2025), including QMS creation, full Annex II/III technical documentation, and TÜV SÜD Stage I and Stage II audits.

What IVDR class are NGS diagnostic panels?

Most NGS-based IVDs classify as IVDR Class C under Annex VIII classification rules, because they typically provide information used to determine patient predisposition or individual risk for serious conditions (e.g., hereditary cancer panels, germline disease testing). NGS panels intended for infectious disease detection with high public health risk (e.g., HIV, hepatitis) may classify as Class D. Companion diagnostic NGS panels co-developed with a therapeutic product also typically fall under Class C. Classification depends on the specific intended use and clinical claims, not the technology itself. All Class C and D IVDs require Notified Body conformity assessment.

Do you need separate UDI identifiers for NGS software under IVDR?

Yes, when the bioinformatics pipeline qualifies as standalone software (SaMD) or is a distinct regulated component, IVDR requires a separate Basic UDI-DI. In the Fulgent case, MDx split the documentation into two Basic UDI-DIs: one for FulgentExome (the wet-lab component) and one for Fulgent PLM (the bioinformatics pipeline). This separation aligns with IVDR expectations for traceability, lifecycle control, and independent conformity assessment. Each Basic UDI-DI has its own technical documentation, risk management file, and performance evaluation. This approach also makes post-market updates easier, a software update does not trigger re-review of the entire wet-lab documentation.

Can a CLIA/CAP-accredited laboratory use its existing QMS for IVDR CE marking?

No, CLIA/CAP accreditation and ISO 15189 certification are not equivalent to ISO 13485, which is the QMS standard required for IVDR CE marking. While CLIA/CAP provides a strong operational foundation (proficiency testing, personnel qualifications, quality control), it does not cover medical device design controls, supplier management, CAPA, post-market surveillance, or the device lifecycle documentation that IVDR demands. Laboratories transitioning from CLIA/CAP to IVDR must implement an ISO 13485-compliant QMS and document design inputs, outputs, verification, validation, and change control for each IVD product.

What is the tiered evidence strategy for scientific validity of large NGS panels?

For panels targeting thousands of genes, it is typically not feasible to generate individual clinical evidence for every gene-disease association. A tiered approach addresses this: Tier 1 validates the underlying sequencing technology (e.g., exome sequencing as a methodology) with evidence from published literature and peer-reviewed validation studies. Tier 2 relies on curated public databases such as ClinVar, OMIM, and HGMD to establish gene-disease associations at scale. Tier 3 provides deep exemplar evidence (including analytical and clinical performance data) for a representative subset of high-prevalence genes. Genes with limited data are supported through a Post-Market Performance Follow-up (PMPF) plan that progressively strengthens evidence after CE marking. This strategy was accepted by TÜV SÜD in the Fulgent certification.

Written by:
Carlos Galamba

Carlos Galamba

CEO

Senior regulatory leader and former BSI IVDR reviewer with deep experience in CE marking high-risk IVDs, companion diagnostics, and IVDR implementation.
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FDA Laboratory Developed Tests (LDTs) Regulation

October 4, 2023

The FDA Laboratory Developed Tests regulation marks one of the most significant shifts in U.S. diagnostic oversight in decades. The FDA’s new rule phases in full regulation of LDTs over four years, with no grandfathering. This change elevates the importance of IVD CROs, whose regulatory and clinical expertise will be critical as laboratories adapt to stringent new requirements. The rule represents a major transformation in the U.S. IVD landscape and will reshape how laboratories develop, validate, and maintain LDTs.

Introduction

On September 29, 2023, the FDA released a groundbreaking proposed rule that fundamentally redefines how the agency regulates Laboratory‑Developed Tests (LDTs). This proposal shifts LDTs out of decades of enforcement discretion and brings them fully under the FDA’s medical device framework.

Because LDTs are a subset of in vitro diagnostic products (IVDs), the new rule has sweeping implications for clinical laboratories, manufacturers, and the broader diagnostics industry. Under the FDA Laboratory Developed Tests regulation, LDTs will now be treated like other medical devices—requiring quality systems, medical device reporting, registration, listing, and in many cases, premarket review.

For stakeholders across the IVD sector, this change is significant.

Key Points to Consider as the FDA regulates LDTs

  1. Expanded Definition of IVDs
    The FDA proposes to explicitly classify LDTs as IVDs under 21 CFR 809.3.
    This means LDTs will now fall under the same requirements as traditional IVD medical devices.
  2. Phased, Four‑Year Implementation
    The FDA will remove enforcement discretion in five stages over a four‑year timeline.
    Each stage introduces new regulatory obligations for laboratories.
  3. No Grandfather Clause
    The proposal does not exempt existing LDTs. All LDTs (old and new) must eventually comply.
  4. Test Categories Exempt from Enhanced Oversight
    Certain test types, including forensic tests and HLA assays, are proposed for exemption.
  5. Public Comment Period
    Stakeholders were invited to submit comments through December 4, 2023.

Background on FDA Regulation for LDTs and IVDs

IVDs have traditionally been subject to rigorous regulatory scrutiny under various heads:

  • 510(k) premarket notification or premarket approval (PMA)
  • Quality system regulation
  • Medical device reporting
  • Registration and listing
  • Labeling

LDTs, however, historically operated under enforcement discretion, receiving minimal oversight. This approach was based on the assumption that LDTs were low risk and used primarily within single laboratories.

That landscape has changed.

The Evolving Landscape of LDTs

Over the last 50 years, LDTs have become increasingly complex, widely used, and technically sophisticated. This evolution has driven demand for stronger oversight in areas such as:

  • Clinical validity
  • Analytical performance
  • Manufacturing consistency
  • Patient safety

The new FDA Laboratory Developed Tests regulation directly responds to these gaps. By redefining LDTs and removing enforcement discretion, the FDA aims to strengthen public health protections.

The Road Ahead: Key Regulatory Impacts

The phased implementation timeline will introduce major compliance requirements:

Medical Device Reporting

The first enforcement area to take effect.

Quality Systems Regulation

Expected three years after publication of the final rule.

Premarket Review

Introduced 3.5 to four years after the final rule, starting with high‑risk LDTs and expanding to moderate-and-low risk tests.

Labs performing LDTs must begin planning now. Clinical and analytical validation, documentation systems, and regulatory processes will all require upgrades.

Alignment With Europe’s IVDR Rollout

The FDA’s new approach mirrors developments in Europe under the In Vitro Diagnostic Regulation (IVDR). The IVDR already applies strict rules to in‑house tests and LDTs, requiring:

  • Complete Technical Documentation
  • A compliant Quality Management System
  • Performance evaluation and validation
  • Adherence to Article 5.5 requirements for in‑house devices

çUnder IVDR, an LDT cannot be used if an equivalent CE‑marked test exists. This forces laboratories to justify in‑house development and meet near‑manufacturer‑level standards.

Conclusion: An Industry in Transition

As experts in IVD quality, regulatory, and clinical operations, MDx CRO encourages laboratories and manufacturers to prepare now for the FDA Laboratory Developed Tests regulation. Although legal challenges may influence the timeline, increased oversight is inevitable, and already fully established within Europe under the IVDR.

Stakeholders should submit comments to the FDA by December 4, 2023, and begin strengthening their regulatory systems immediately.

Written by:
Carlos Galamba

Carlos Galamba

CEO

Senior regulatory leader and former BSI IVDR reviewer with deep experience in CE marking high-risk IVDs, companion diagnostics, and IVDR implementation.
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IVDR Compliance: Progress in EU Reference Laboratories and consequences for High-Risk IVDs

June 22, 2023

EU Commission evaluates EURLs

The European Commission is making significant progress in evaluating applications for EU reference laboratories (EURLs) to ensure compliance with the In Vitro Diagnostic Medical Devices Regulation (IVDR). These designated laboratories play a vital role in upholding the safety and efficacy of high-risk in vitro diagnostic medical devices (IVDs) within the European Union (EU).

In accordance with Article 100 of Regulation (EU) 2017/746, the Commission has been diligently assessing the applications received for EURL designation. The EURLs are entrusted with key responsibilities related to IVDR compliance, including advisory roles and activities associated with market access, specifically for class D devices that carry the highest level of risk. These laboratories are responsible for verifying the performance and ensuring the conformity of class D devices with common specifications, as well as conducting batch testing.

While no EURLs have been designated under Regulation (EU) 2017/746 thus far, the European Commission launched a call for applications in July 2022, targeting eight categories of class D devices. These categories encompass various areas such as hepatitis and retroviruses, herpesviruses, bacterial agents, arboviruses, respiratory viruses causing life-threatening diseases, haemorrhagic fever and other biosafety level 4 viruses, parasites, and blood grouping.

Candidate laboratories were invited to submit their applications to the national contact points in their respective Member States by January 2023. Subsequently, Member States were responsible for submitting the applications on behalf of the candidate laboratories to the European Commission, with a deadline of March 31, 2023.

8 Laboratories apply for designation

As of the deadline, the European Commission has received eight applications for review. These applications are currently undergoing a comprehensive assessment based on the specific criteria outlined in the call for applications. The evaluation process ensures that applicant laboratories meet the necessary standards and possess the combined capacity to handle the expected volume of requests related to market access tasks.

The European Commission aims to conclude its assessment process by the third quarter of 2023. However, it has been determined that none of the applicant laboratories in the category of haemorrhagic fever and other biosafety level 4 viruses possess the required combined capacity to adequately address the anticipated volume of requests. Consequently, no EU reference laboratory will be designated for this particular category following the current call for applications.

Despite the absence of a designated EURL, manufacturers can still pursue conformity assessment of their IVDs through notified bodies, allowing for certification and lawful placement of products on the EU market in adherence to Regulation (EU) 2017/746.

It is important to note that additional calls for EURLs in the field of IVDs may be issued in the future, and relevant information will be published in advance to facilitate preparedness among stakeholders.

For detailed guidance on the integration of EURLs into the conformity assessment process once they are designated, manufacturers are encouraged to refer to MDCG 2021-4.

The establishment of EU reference laboratories marks a significant stride towards enhancing IVDR compliance and ensuring the quality and safety of high-risk IVDs across the European Union. The European Commission’s thorough evaluation process and steadfast commitment to regulatory compliance are instrumental in safeguarding public health and fostering innovation in the field of in vitro diagnostics.

MDx CRO: Your Partner for High-Risk IVD Studies 

Looking to navigate the stringent requirements of EU common specifications and EURL standards?

Partner with MDx CRO. Our expert team specializes in designing and conducting IVD studies that meet these rigorous demands.

We offer:

  • Customized Study Design: Tailored protocols aligned with high-risk IVD requirements, common specifications and EURL expectations.
  • ISO 20916 Clinical Performance studies in state-of-the-art EU laboratories: Accurate and reliable studies to demonstrate IVD clinical performance.
  • Regulatory Compliance Support: Expert guidance throughout the regulatory journey
  • Quality and Timeliness: Efficient execution, precise data collection, and timely reports.

With MDx CRO as your ally, achieve IVDR compliance and bring your high-risk IVDs to market confidently.

Contact us today to discuss your needs and ensure a predictable go-to-market strategy.

FAQs

Q: What tasks do EU Reference Laboratories (EURLs) perform?

A: EURLs have a range of important tasks designed to ensure effective IVDR compliance. These tasks include:

  • Verification of performance: EURLs verify the performance claimed by manufacturers and ensure compliance with Common Specifications or other solutions.
  • Testing of devices: EURLs perform tests on samples of manufactured class D devices or batches of class D devices to ensure their quality and safety.
  • Scientific and technical assistance: EURLs provide valuable scientific and technical assistance, opinions, and advice to support regulatory decision-making.
  • Network management: EURLs establish and manage networks and sub-networks of reference laboratories to facilitate collaboration and exchange of knowledge and expertise.
  • Development of testing methods: EURLs contribute to the development of appropriate testing and analysis methods for IVDs, promoting standardized practices.
  • Collaboration with notified bodies: EURLs collaborate with notified bodies to develop best practices and ensure consistency in conformity assessment procedures.
  • Recommendations on reference materials: EURLs provide recommendations on suitable reference materials and measurement procedures to enhance accuracy and reliability.
  • Contribution to standards development: EURLs actively participate in the development of Common Specifications (CS) and international standards to align regulatory requirements.

Q: Are EURLs only for class D devices?

A: While EURLs are primarily intended for class D devices, there is provision for an EU reference laboratory to be assigned for class C devices upon request from a Member State.

Q: What is the purpose of creating a network of laboratories across the European Union?

A: The aim is to establish a broad network of laboratories throughout the European Union to enhance the safety and compliance of the IVD market. These laboratories will adopt harmonized methods, ensuring coordinated processes, consistent testing protocols, and standardized reporting. They will also cooperate in quality assessment tests, develop joint guidelines, and coordinate the introduction of testing methods for emerging technologies.

Q: How will EURLs contribute to making the IVD market safer and compliant?

A: EURLs play a crucial role in verifying device performance, conducting rigorous testing, and providing scientific expertise. By adopting harmonized methods and collaborating within the network, EURLs ensure consistency, accuracy, and reliability in the assessment of IVDs. This ultimately contributes to a safer and more strictly IVDR compliance framework within the European Union.

Written by:
Carlos Galamba

Carlos Galamba

CEO

Senior regulatory leader and former BSI IVDR reviewer with deep experience in CE marking high-risk IVDs, companion diagnostics, and IVDR implementation.
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New Regulation on In Vitro Diagnostic Medical Devices in Spain: Are You Ready?

June 2, 2023

Are you ready for the new regulation on In Vitro Diagnostic medical devices in Spain? Learn everything you need to know about it.

The in vitro diagnostic medical device sector plays an important role in healthcare by providing instruments and solutions for illness diagnosis and monitoring. Regulatory agencies regularly update and adopt new regulations to maintain the safety and effectiveness of these products.

Recently, the public consultation process for the new regulation on In Vitro diagnostic medical devices in Spain, replacing the previous Royal Decree 1662/2000, has been completed.

The proposed text’s draft can be accessed on the website of the Spanish Ministry of Health. The new decree aims to adopt the required regulatory measures in areas where Regulation (EU) 2017/746 allows member states to establish national regulations.

These regulations address key aspects such as manufacturer licensing, clinical studies, and the production of in vitro diagnostic devices for exclusive use in healthcare facilities.

New Regulation on In Vitro Diagnostic Medical Devices: 5 Key aspects

1. Operating License

The new regulation on In Vitro diagnostic medical devices, like the previous one, requires manufacturers, importers, and now those who make finished products for third parties to get a prior operating licence.

To assure product quality and the execution of key procedures and controls, manufacturers must have a quality management system in place. They must also have suitable facilities, procedures, equipment, and personnel for the corresponding activities and products.

The new regulation maintains the figure of the technical responsible person, who must have a minimum higher education degree.

Although the requirements and duties of the technical responsible are not the same as those of the personnel responsible for regulatory compliance as set out in Regulation (EU) 2017/746, they may be covered by the same person if they meet all the requirements.

2. Registration and Marketing Obligations

The second key aspect of the new regulation for In Vitro diagnostic medical devices makes a reference to registration and marketing obligations.

Before beginning their activities, any economic operator seeking to market products in Spain has to register in the Commercialization registration of the Spanish Agency of Medicines and Medical Devices.

Economic operators must keep written records of the products they make available in Spain and must notify the regulator of any changes in this information or cessation of activity. This registration is required to assure the traceability and safety of the product.

Economic operators must disclose information in Spanish if health authorities make a justified request, but they may submit documentation in other languages to demonstrate product conformity. Importers and distributors must get the necessary documentation from the manufacturer or authorised representative if it is not available.

The new regulation for in vitro diagnostic medical devices mandates the creation of a document archive system to store the documentation generated for each product and to keep a record of all products for traceability purposes.

Manufacturers must make the records available to relevant authorities for at least ten years following the product’s last market release, even in extreme situations such as bankruptcy or the suspension of business.

These requirements ensure that manufacturers maintain rigorous control over the quality and safety of their products and facilitate supervision by authorities. It is important to note that some of these obligations do not apply to pharmacies, as they have their own records.

3. In-House Product Manufacturing

The manufacturing of in-house products in health institutions is subject to strict regulations under the new regulation for in vitro diagnostic medical devices to ensure product safety and quality. In line with Regulation (EU) 2017/746, the new text recognizes that all health institutions can carry out the manufacturing of in vitro diagnostic devices for exclusive use within those centres, not limited to hospitals as it is the case with medical devices.

However, to do so, they must comply with all the requirements established in Article 5(5) of the Regulation (EU) 2017/746. It is important to mention that health institutions cannot subcontract manufacturing outside Spanish territory.

Additionally, they must designate a responsible person for manufacturing procedures and communicate their data to the Spanish Agency of Medicines and Medical Devices. This ensures traceability and regulatory compliance in the manufacturing process.

The sale of products manufactured in these centres to the public or third parties is not permitted. Moreover, health institutions must provide prior communication of the start of manufacturing activities, providing detailed information and complying with the required documentation.

The agency can conduct subsequent verifications and inspections to ensure compliance.

4. Performance Studies

The new regulation for in vitro diagnostic medical devices addresses the requirements and procedures related to clinical performance studies in the field of in vitro diagnostic medical devices. Ethical and subject protection principles must apply to these studies.

Products intended for clinical performance evaluation studies must receive approval from the Research Ethics Committee and the centre’s management before they can begin. Interventional clinical performance studies and other functional performance studies involving risks to test subjects require authorization from the AEMPS (Spanish Agency of Medicines and Medical Devices).

The text establishes provisions regarding documentation, product supply, insurance, compensation for damages, and liability regime for sponsors.

5. Market Surveillance and Control

The system of market surveillance and control is essential for ensuring the safety and quality of in vitro diagnostic medical devices according to the new regulation for in vitro diagnostic medical devices.

Manufacturers, healthcare professionals, authorities, and users play a crucial role in this process, working together to protect public health and ensure regulatory compliance.

Manufacturers must report incidents in accordance with established protocols. Additionally, healthcare professionals, authorities, and users have the responsibility to report serious incidents to the Spanish Agency of Medicines and Medical Devices. Health institutions must designate a surveillance responsible person and communicate their data to the relevant health authorities.

Manufacturers must also report safety corrective actions and provide information in Spanish to ensure effective dissemination. The Spanish Agency of Medicines and Medical Devices coordinates market control activities in collaboration with regional health authorities, including periodic inspections.

Other specific aspects and details are regulated by this regulation, such as the use of products that have not yet demonstrated conformity or aspects related to genetic testing.

It is important underlying the significance of regulatory compliance and quality in the manufacture of these products, as well as how a regulatory, quality, and clinical consultancy service organisation may be a strategic ally in this highly regulated and ever-changing environment.

We must be prepared to comply with the royal decree once the parliamentary procedures are concluded and the new regulation for in vitro diagnostic medical devices is authorised.

How can MDx CRO help?

Are you finding it challenging to navigate the complexities of the new in vitro diagnostic medical device regulations in Spain? Is the realm of IVD consulting seeming increasingly vital to your business? Look no further than MDx CRO, your dedicated partner in this journey.

With a team of experienced IVD consultants, we provide robust solutions for regulatory, quality, and clinical consultancy services tailored to your needs. As your IVD consultancy partner, we offer comprehensive assistance in manufacturer licensing, clinical studies, and production compliance, ensuring your business aligns seamlessly with the new Royal Decree and Regulation (EU) 2017/746.

Don’t let regulatory hurdles stand in the way of your company’s success. Embrace the change, and navigate this evolving landscape with confidence and ease by leveraging MDx CRO’s expertise.

For a no-obligation discussion on how we can assist you in maintaining your market competitiveness within the IVD sector, contact us today. Let us be your strategic ally in this highly regulated environment, ensuring your continued growth and success.

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The Impact of the IVDR and MDCG 2023-1 on LDTs

January 12, 2023

On May 26, 2022 the new Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) has become fully applicable with major consequences not only for manufacturers of IVDs but also for all diagnostic laboratories, particularly those that manufacture in-house IVDs (often called laboratory developed tests or LDTs).

Although an exemption exists and not all requirements of the IVDR are applicable to LDT IVDs, that exemption is only applicable if several conditions are met as we will discuss later in this blog.With the implementation of the IVDR, EU laboratories, particularly those that manufacture in-house IVDs, are required to comply with EU legislation for the first time, and the workload to meet those requirements is significant.It is also important to note that the discussion of IVDR LDTs is limited to European health institutions.

LDTs manufactured outside the EU, for example, by CLIA-certified US laboratories or other non-EU commercial laboratories, are not eligible for the IVDR LDT/in-house exemption neither they can fulfil the conditions set out in article 5(5) of the IVDR. If these companies provide testing on EU patients through institutions outside of the EU, their IVD tests should be in full compliance with the IVDR by now (including conformity assessment with a Notified Body) which sees scrutiny rise to a completely different level than what they are used to.

The only exception is if there was a signed declaration of conformity for a specific test under the IVD directive (IVDD) prior to the 26th of May 2022, which could have granted that test additional transition time based on the IVDR progressive roll-out that is currently in place. This is unusual because non-EU LDTs were not covered by the previous IVDD, and most companies providing these tests in Europe should now be fully compliant with the IVDR.

Article 6 of the IVDR (distance sales) regulates such commercial activities and states that commercial laboratories operating outside of the EU but providing testing to EU citizens must fully comply with the IVDR.

The impact of IVDR, ISO 15189:2022 changes, and the publication of MDCG 2023-1

In this blog we will examine key topics such as:

  • What conditions must be met in order to continue manufacturing in-house/LDT IVDs in the EU?
  • Changes in the new ISO 15189:2022 standard
  • MDCG 2023-1 Guidance on the Health Institution Exemption under Article 5(5) of the IVDR, which was recently published.
  • What steps should IVDR LDT manufacturers take right now?
  • How can MDx assist?

Conditions for IVDR LDTs and their deadlines

Under the IVDR, IVDs can be manufactured and used within EU health institutions (in-house devices) on a non-industrial scale to address specific target patient group needs, or when there isn’t an equivalent CE-marked IVD on the market.

It is important to note that each EU member state has the right to restrict the use of such devices and therefore we are likely to see differences being applied on a EU level when it comes to restrictions on in-house devices.

However, the following main conditions must still be met for the exemption to apply:

Condition #1 – No transfer of devices [IVDR article 5(5)a]

IVDs such as reagents and control materials may not be distributed to other legal entities. Material distribution for external quality assessment is an exception (see IVDR Art. 1(3)). Documents such as protocols/standard operating procedures (SOPs) may also be distributed because they are not devices. Furthermore, there are no restrictions on testing samples obtained from external sources. As a result, reference hospitals can continue to analyse samples from hospitals that are unable to perform the test in question, as long as it is not done on an industrial scale.

Timeline: in-house IVDs cannot be transferred to other legal entities from 26 May 2022

Condition #2 –  Compliance with EN ISO 15189 [article 5(5)b, c]

Diagnostic laboratories that use in-house IVDs must comply with the EN ISO 15189 standard (recently updated to the 2022 version), which specifies quality and competence requirements in medical laboratories. Accreditation is not strictly necessary unless your member state requires it, but it is good to be aware that external audits are a solid foundation for improving a QMS. A QMS established in accordance with ISO 15189 has generally been acceptable amongst the medical laboratory community, however MDCG 2023-1 confirms that compliance to EN ISO 15189 alone is not sufficient for the manufacture of in-house IVDs. The QMS should extend to other areas that are necessary for IVDR compliance, including for example risk management and manufacturing, by making use of appropriate standards particularly if they are harmonised to the IVDR. MDCG 2023-1 suggests that elements of ISO 13485 (medical devices) and ISO 14791 (risk management) should be incorporated in the QMS. In-house test manufacturers will need to determine the best way to comply with ISO 15189 and the IVDR requirements in Annex I concurrently.

Timeline: compliance with ISO 15189 is required by 26 May 2024

What is ISO 15189:2022?

ISO 15189:2022 specifies quality and competence requirements for medical laboratories. ISO 15189 is applicable not only to medical laboratories developing management systems and assessing their competence, but also to users, regulatory authorities, and accreditation bodies confirming or recognizing the competence of medical laboratories.

ISO 15189:2022 vs 2012: main changes!

Because of the alignment with ISO/IEC 17025:2017-General Requirements For The Competence Of Testing And Calibration Laboratories, the management requirements are now at the end of the document.
– Added requirements for point-of-care testing (POCT) (based on ISO 22870:2016) which is a new addition to the standard’s scope.
– A stronger emphasis on risk management: requires laboratory managers to establish, implement and maintain risk management processes and evaluate their effectiveness; and extends risk measures by requiring safeguards that can prevent unintended adjustments of laboratory equipment.
– New terms & definitions: e.g. In vitro diagnostic medical device (IVD), external quality assessment, trueness/measurement trueness and others.

Condition #3 –  Justification of use and unmet needs [Article 5(5) d]

The use of CE-IVDs is the default option under the IVDR. Only when no equivalent CE-IVD is available, or when an equivalent CE-IVD cannot meet the specific needs of a target patient group at the appropriate level of performance, is the use of in-house IVDs permitted. This implies that IVDR LDTs can be used when they perform better, i.e. when their use benefits patient safety and health. A written statement justifying the manufacture, modification, and use of in-house IVDs should be available for review by the national competent authority, which oversees the enforcement the IVDR and judges the justification’s validity.

One of the most pressing issues is what constitutes an appropriate justification for unmet need. MDCG 2023-1 provides some further clarity that the justification can be based on technical, biological or clinical aspects of the device “e.g. different intended purpose, different clinical conditions, different patient group, different conditions of use, different principles of operation, different approved specimen materials, different critical performance characteristics or different critical technical specifications”. To establish that an equivalent CE marked device does not exist, MDCG 2023-1 recommends that medical laboratories implement a process to examine the market, for example by consulting EUDAMED, the European database on medical devices or other processes. Furthermore, the justification should be reviewed on a regular basis.

Timeline: 26 May 2028 for the justification to be fully available in the health institution documentation. Please note that the competent authority may submit requests for information already from 26 May 2024.

Condition #4 – Public declaration and GSPR compliance [article 5(5)f]

One of the other conditions to continue manufacturing in-house devices is that the health institution prepares a public declaration with the name and address of the manufacturing health institution, the details of the IVD LDT and confirmation that the device meets the GSPRs set out in Annex I of the IVDR. Where a GSPR is not met in full an appropriate justification is required. This is best addressed by means of a GSPR checklist that should be prepared for the in-house device.

Annex A of MDCG 2023-1  provides a template for this public declaration.

Timeline: public declarations will need to be available by 26 May 2024

Condition #5 – Additional requirements for class D IVDR LDTs [article 5(5) g,h]

The requirements for class D tests are more stringent than those for classes A-C tests. More information on the manufacturing, design, and performance of IVDR LDTs is needed. This means that the GSPR for class D tests should be met and documented in greater detail, largely aligned with that produced for CE-IVDs, i.e. in accordance with Annex II’s technical documentation requirements. For example, there should be documentation that demonstrates how the analytical and clinical performance data support the intended purpose of the in-house device.

Timeline: 26 May 2024

Condition #6 – Clinical experience gained [article 5(5) i]

The experience gained from clinical use of the device should be used by the health institution to review the device performance and to take all necessary corrective actions. The strategy for the evaluation of the use of the in-house IVD should be aligned with post-market surveillance requirements and a documented procedure should be in place.

Timeline: processes to review clinical experience gained should be implemented by 26 May 2024

5 actions laboratory test developers must take right now.

  1. Review the IVDR and establish the appropriate regulatory framework for your unique circumstances:
    Health institutions based in Europe can make use of article 5(5) in the IVDR to continue manufacturing IVDR LDTs under certain conditions.Laboratories that provide testing on European patients but are based outside of the EU (article 6 distance sales), are not granted an in-house exemption and therefore must meet the IVDR in full if they wish to continue to provide testing on EU specimens.
  2. Review assay portfolio and identify which are in-house IVDs vs CE-IVDs
    For health institutions based in the EU: review the possible classification of your in-house IVDs against Annex VIII (Classification rules) of the IVDR. In-house tests that fall in class D will have stricter requirements to fulfil.
  3. Ensure all conditions have been met for your laboratory to continue manufacturing in-house IVDs
    As of May 2022, devices can no longer be transferred to other legal entities. This is likely to be interpreted differently from member state of member state, depending on how healthcare systems are organised in a particular country. You may seek to clarify your circumstances with your national competent authority.Familiarise with the deadlines for each in-house test condition that applies. For example some requirements have applied in May 2022 (e.g. prohibition to transfer devices to another legal entity), whereas others will become applicable from May 2024 (e.g. ISO 15189 implementation) or May 2028 (e.g. written justification for unmet needs of specific target patient groups).Where relevant, ensure that you have documented evidence to support your obligations under article 5(5).
  4. Implement a suitable quality management system
    ISO 15189:2022 has recently been published and has introduced several changes when compared to ISO 15189:2012. However, regulators continue to believe that this standard is insufficient to address the manufacture of in-house IVDs. As a minimum, your quality management system will need to be supplemented with additional controls from other key medical device standards such as ISO 14971 and ISO 13485.
  5. Conduct a review of your IVDR LDTs against the general safety and performance requirements (GSPR) in Annex I of the IVDR
    The health institution is legally responsible for the public declaration on the in-house IVD and therefore should complete a full review of all relevant GSPRs and ensure that a justification is readily available for any GSPRs that are not met in full.

How can MDx help with your IVDR LDTs?

MDx CRO is a leading quality, regulatory and contract research consulting company dedicated to the medical device and diagnostic sectors.

With the introduction of the IVDR, the requirements for in-house devices and laboratory developed tests (LDTs) have grown significantly. Whether you are a health institution in the EU or a commercial laboratory outside of the EU, our MedTech team can assist you in developing a compliance strategy and will be with you every step of the way.

Our IVDR Laboratory services have been tailored for the needs of in-house test developers and include:

  • Regulatory strategy: includes classification review, intended purpose review, technical documentation needs assessment, and a strategic assessment of regulatory needs with a focus on reducing the compliance burden.
  • Creation of QMS procedures to meet the requirements of the in-house test environment whilst meeting EU IVDR requirements.
  • Assessment of all conditions in article 5(5)
  • Gap assessment of your QMS system
  • Medical writing
  • Creation of technical documentation to support Class D in-house IVDs
  • Creation and completion of GSPR checklists
  • Support with notified body applications
  • Support with competent authority requests
  • ISO 14971:2019 gap analysis and implementation
  • ISO 13485:2016 gap analysis and implementation
  • ISO 15189:2022 gap analysis and implementation

Please reach out today for a consultation with our team of IVDR LDTs experts.

Written by:
Carlos Galamba

Carlos Galamba

CEO

Senior regulatory leader and former BSI IVDR reviewer with deep experience in CE marking high-risk IVDs, companion diagnostics, and IVDR implementation.
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