IVD Clinical Trials: The Do’s and Don’ts (2026 IVDR Update)

January 26, 2026

Carlos Galamba

What separates a successful IVD clinical performance study from one that gets rejected by a Notified Body? With the IVDR now fully in force, MDCG 2025-5 reshaping how performance studies are planned, and the proposed IVDR targeted revision on the table, the rules have changed significantly since our original article. This 2026 update covers everything IVD manufacturers and sponsors need to know to design, conduct, and report performance studies that meet current regulatory expectations, and avoid the most common pitfalls we see in the field.

Why This Article Needed a 2026 Rewrite

When we first published this guide, the IVD landscape looked very different. Since then, several regulatory milestones have fundamentally changed how IVD clinical performance studies must be planned and executed:

MDCG 2025-5 In June 2025, the Medical Device Coordination Group published 54 Q&A clarifying performance study requirements under IVDR Articles 57–77. This document addresses when studies require competent authority authorisation versus notification, how to handle companion diagnostics, and what constitutes a substantial modification. It has become the go-to reference for sponsors planning studies in the EU.
ISO 20916:2024 with Annex ZA The revised standard now formally maps its clauses to IVDR requirements, creating a single harmonised pathway for clinical performance study conduct. While official recognition as an IVDR harmonised standard in the EU Official Journal is still pending, Notified Bodies are already referencing Annex ZA during reviews.
The proposed IVDR targeted revision (COM(2025) 1023) Published in December 2025, this European Commission proposal includes direct changes to performance study requirements. Among them: performance studies involving only routine blood draws would no longer require prior authorisation, and the mandatory notification for CDx studies using exclusively leftover samples would be removed. This is still a legislative proposal, it must pass through Parliament and Council, but it signals the direction of travel.
IVDR transition milestones for 2026 Under Regulation (EU) 2024/1860, Class C legacy devices must submit a formal IVDR certification application to a Notified Body by 26 May 2026. This means many manufacturers are running performance studies under significant time pressure right now.

These developments make the difference between planning a study that sails through regulatory review and one that stalls at the first checkpoint.

Read our in-depth IVDR clinical study guide to learn more.

A note on terminology: Under the EU IVDR 2017/746, what was traditionally called an “IVD clinical trial” is formally a clinical performance study. This article uses both terms, as many professionals still search for “IVD clinical trials,” but the regulatory-correct term is clinical performance study. Understanding this distinction matters, using incorrect terminology in submissions has been flagged as a cause of delays by competent authorities.

Understanding the IVDR Performance Study Framework

Before diving into the do’s and don’ts, it is essential to understand the regulatory architecture that governs these studies. Under the IVDR, the performance evaluation of an IVD device rests on three pillars:

Scientific validity — The documented association between an analyte and a clinical condition or physiological state (IVDR Article 2(37)).
Analytical performance — The ability of the device to correctly detect or measure a particular analyte. This is evaluated through bench studies covering parameters like sensitivity, specificity, accuracy, precision, and reproducibility (Annex I, Section 9.1).
Clinical performance — The ability of the device to yield results that are correlated with a particular clinical condition or pathological process, as relevant for the target population and intended user (IVDR Article 2(40)).

Clinical performance studies address the third pillar. They are required by default under IVDR Article 56(4), unless the manufacturer can provide due justification for relying on other sources of clinical performance data such as published literature, routine diagnostic data, or results from previous studies.

MDCG 2025-5 clarifies an important nuance: it is not always required to perform both analytical and clinical performance studies. However, analytical performance must always be demonstrated through study data, while clinical performance may draw on a combination of study results, peer-reviewed literature, and data from routine diagnostics.

The results of all three pillars feed into the Performance Evaluation Report (PER), a mandatory component of IVDR technical documentation reviewed by Notified Bodies during the conformity assessment process.

IVD Clinical Performance Studies: The Do’s

1. Start with a Robust Clinical Performance Study Plan

The Clinical Performance Study Plan (CPSP) is the backbone of your study. Under IVDR Annex XIII, Section 2, and ISO 20916:2024, the plan must define:

Study objectives and clearly formulated endpoints
Target population and specimen types
Inclusion and exclusion criteria
Study design type (observational vs. interventional, this distinction has regulatory consequences for authorisation requirements)
Statistical methodology, including sample size justification
Comparator or reference method selection
Data management procedures
Ethical considerations and informed consent procedures
Risk assessment for study participants

A common mistake is treating the CPSP as a formality. In practice, the CPSP is the first document a competent authority and ethics committee will scrutinise. A weak plan creates downstream problems that are expensive to fix once the study is underway.

2026 consideration: MDCG 2025-5 makes clear that the study design must be aligned with the device’s intended purpose as defined by the manufacturer. The intended purpose drives the scope of the required performance evidence, so any ambiguity in intended purpose will cascade into problems with the study plan, the submission, and ultimately the CE marking process.

2. Determine Your Regulatory Pathway Early

Not all performance studies follow the same regulatory route. Under the IVDR:

Article 58(1) studies require application for authorisation to the competent authority. These include interventional clinical performance studies where the study procedure involves additional invasive specimen collection, or where the results are used to guide patient management.
Article 58(2) studies specifically cover companion diagnostics, which always require authorisation when the CDx is investigational and specimens are prospectively collected.
Article 70 studies involve post-market performance studies using CE-marked devices used within their intended purpose, these generally require notification rather than full authorisation.
Other performance studies, such as those using exclusively leftover samples with no additional invasive procedures, may only need notification or, in some cases, fall outside the scope of Articles 58 and 70.

MDCG 2025-5 includes a decision flowchart (Appendix I) that helps sponsors determine which regulatory route applies to their specific study. Use it.

2026 consideration: The proposed IVDR revision (COM(2025) 1023) would simplify this landscape further, removing the authorisation requirement for studies involving only routine blood draws, and eliminating mandatory notification for CDx studies using exclusively leftover samples. However, these changes are not yet in force.

3. Account for National Variations Across EU Member States

The IVDR provides the regulatory framework, but ethics review requirements are set at the national level. MDCG 2025-5 explicitly reminds sponsors that it is necessary to check national requirements in each Member State where specimen collection occurs.

This means that a multi-country study can face different timelines, documentation requirements, and approval processes depending on the jurisdictions involved. Some Member States have well-established procedures for IVD performance study applications; others are still developing their processes under the IVDR.

Practical tips:

The specimen collection site (not the analysis site) determines which Member State’s regulatory requirements apply (MDCG 2025-5, Q20).
Plan for at least 38 days after notification before implementing any substantial modifications (this can be longer if expert consultation is triggered).
Language requirements for patient-facing documents vary by country.
Some Member States require parallel ethics committee and competent authority submissions; others accept sequential approaches.

4. Invest in Biostatistics from Day One

Biostatistics is not an afterthought, it is a design input. A qualified biostatistician should be involved from protocol development through final analysis. Key contributions include:

Sample size calculation An undersized study produces inconclusive results; an oversized study wastes time and resources. Both are avoidable with proper statistical planning.
Endpoint definition Clinical performance endpoints (sensitivity, specificity, predictive values, diagnostic accuracy) must be precisely defined and measurable.
Bias control Randomisation, blinding, and confounding factor management must be built into the design, not retrofitted.
Statistical analysis plan (SAP) This should be finalised before data collection begins. Post-hoc analysis adjustments are a red flag for Notified Bodies.

Under IVDR Annex XIII, Section 2.3.2, the competent authority may assess the statistical approach, study design, sample size, selected comparators, and choice of endpoints as part of the review process.

5. Use Validated Assays That Represent the Final Product

The IVDs used in clinical performance studies must accurately represent the final product as intended for commercial distribution. This means the device version used in the study should be equivalent, in terms of reagents, protocols, software, and hardware, to what will be placed on the market.

If the device undergoes changes between the study and CE marking, the manufacturer must justify that those changes do not invalidate the clinical performance data. Notified Bodies scrutinise this carefully.

IVDR Annex XIII also requires that analytical performance be established before or in parallel with the clinical performance study. There is no point in demonstrating that a device correlates with a clinical condition if the underlying analytical performance has not been characterised.

6. Follow Good Study Practice, Not GCP

This is a critical distinction that MDCG 2025-5 and industry experts have repeatedly emphasised. IVD performance studies are governed by Good Study Practice (GSP) as defined in ISO 20916, not Good Clinical Practice (GCP) as defined in ICH E6.

GCP was developed for pharmaceutical clinical trials and is referenced in ISO 14155 for medical device clinical investigations. While some principles overlap, the frameworks are different. Submitting a performance study designed under GCP rather than GSP can raise concerns during review and may even lead to rejection.

ISO 20916:2024, with its new Annex ZA, provides the direct link between GSP requirements and IVDR regulatory expectations. Sponsors should design their quality systems and study procedures around this standard.

7. Maintain Rigorous Data Management and Documentation

Data integrity is a central requirement under IVDR and ISO 20916. Your data management plan should cover:

How data will be collected, entered, and verified
Electronic data capture systems and their validation status
Source data verification procedures
Audit trail requirements
GDPR compliance for personal and health data across all participating countries
Data monitoring procedures and triggers for quality review

The Clinical Performance Study Report (CPSR) the final output of the study, feeds directly into the Performance Evaluation Report (PER). Any data integrity issues in the CPSR will compromise the entire PER and, by extension, the CE marking application.

8. Plan for Post-Market Performance Follow-Up from the Start

Under IVDR, clinical evidence is not a one-time exercise. The regulation requires a Post-Market Performance Follow-up (PMPF) plan that describes how the manufacturer will proactively collect and evaluate clinical performance data after the device is on the market.

For Class C and D devices, the PMPF Evaluation Report must be updated annually. Planning the PMPF in parallel with the pre-market study ensures continuity of evidence and avoids gaps that could jeopardise continued market access.

9. Incorporate User Feedback, Especially for Near-Patient and Self-Testing IVDs

Usability and user comprehension data are increasingly important, particularly for IVDs intended for lay users, point-of-care settings, or self-testing. Evidence of appropriate use, comprehension of instructions for use, and error rates should be captured during or alongside the clinical performance study.

This evidence supports compliance with the IVDR General Safety and Performance Requirements (GSPRs) and is expected in the technical documentation reviewed by the Notified Body. MDx’s usability engineering services can help integrate these requirements into your study design.

IVD Clinical Performance Studies: The Don’ts

1. Don’t Confuse Terminology or Regulatory Frameworks

As noted above, using GCP where GSP is required, or referring to your study as a “clinical trial” in regulatory submissions when the IVDR uses “clinical performance study,” can create unnecessary confusion and delays.

Similarly, do not conflate the FDA’s Investigational Device Exemption (IDE) framework with IVDR requirements. While both regulate clinical evidence generation for IVDs, the legal basis, study classifications, submission requirements, and oversight bodies are fundamentally different. An article on running clinical studies under IVDR versus the FDA pathway can help clarify these differences.

2. Don’t Neglect the Application or Notification Step

Depending on the study type (see Article 58(1), 58(2), or 70), your performance study may require formal authorisation from, or notification to, the competent authority in each Member State where specimens are collected. Failing to submit the correct application, or submitting under the wrong article, is a common cause of regulatory delays.

MDCG 2025-5 Appendix I provides a decision tree for determining your obligations. Use it systematically. When in doubt, apply for authorisation rather than merely notifying, it is easier to downgrade than to discover mid-study that you should have applied.

3. Don’t Underestimate Sample Size or Population Selection

A sample size that is too small produces inconclusive results. A sample size that is too large wastes time, budget, and participant goodwill. But more importantly, the study population must be representative of the device’s intended use population.

Under IVDR Annex XIII, the clinical performance study must include participants that reflect the diversity of the real-world target population, including age, gender, disease stage, and comorbidity profiles as relevant. A study conducted exclusively on one demographic may not satisfy Notified Body expectations for generalisability.

4. Don’t Treat Substantial Modifications Lightly

Once a study is authorised or notified, any significant change to the protocol, device, endpoints, or study design may constitute a substantial modification under IVDR Article 71.

MDCG 2025-5 Appendix II provides a non-exhaustive list of changes that may be considered substantial, including:

Changes to the primary endpoint measurement method
Modifications to the device under study (e.g., reagent formulation, software version)
Changes to testing modalities or procedures
Changes to the investigator or study sites
Changes to the statistical analysis plan

Substantial modifications must be notified to the relevant competent authority, and sponsors must typically wait at least 38 days before implementation. Ignoring this requirement can invalidate study data.

5. Don’t Skip the Ethics Review

While the IVDR itself does not impose ethics committee review requirements (these are set nationally), MDCG 2025-5 explicitly reminds sponsors that national ethics requirements must be checked and followed. In most EU Member States, ethics committee approval is required for studies involving human participants, even when leftover samples are used.

Beyond regulatory compliance, ethical oversight protects participants, strengthens the credibility of the study data, and is expected by Notified Bodies reviewing the clinical evidence package.

6. Don’t Rush the Study to Meet Transition Deadlines

With 2026 IVDR transition milestones creating urgency, particularly the 26 May 2026 deadline for Class C Notified Body applications under Regulation (EU) 2024/1860, there is a temptation to cut corners on study design, shorten timelines, or accept suboptimal data quality.

This is counterproductive. A poorly designed or hastily executed study is more likely to result in Notified Body queries, additional evidence requests, or outright rejection, all of which cost more time than doing it right the first time.

7. Don’t Ignore Companion Diagnostic Complexity

Companion diagnostics (CDx) occupy a unique regulatory position. Under the IVDR, CDx performance studies are always subject to Article 58(2) when the CDx is investigational. The regulatory requirements, study design considerations, and evidence expectations are more demanding than for standard IVDs.

For CDx co-development programmes, where the diagnostic is developed in parallel with a therapeutic product, sponsors may also need to coordinate with the European Medicines Agency (EMA) through a pre-submission meeting to align timelines and evidence requirements.

MDCG 2025-5 addresses CDx-specific questions (Q28-Q29), including when a CDx study qualifies as interventional and how leftover samples are handled.

8. Don’t Overpromise the Device’s Performance

Title tags, promotional materials, and even study endpoints sometimes reflect aspirational rather than evidence-based performance claims. The IVDR requires that all performance claims be supported by the clinical evidence package. Overpromising leads to either failed endpoints, misleading data, or post-market compliance issues.

Be transparent about the device’s limitations. Define realistic performance targets based on the state of the art, and design the study to demonstrate what the device actually achieves.

Key Regulatory Updates That Affect Performance Studies in 2026

MDCG 2025-5: What Sponsors Must Know

Published in June 2025, this 54-question guidance document is now essential reading for anyone planning or conducting IVD performance studies. The most impactful clarifications include:

Not all studies need both analytical and clinical components, but analytical performance must always be demonstrated via study data.
Leftover samples can be used in many study types, but the regulatory obligations vary depending on whether the study is analytical or clinical, and whether the IVD is CE-marked.
Specimen collection site determines jurisdiction, not the laboratory analysis site.
“Research Use Only” (RUO) products used with a medical purpose in a performance study become IVDs under the IVDR and must meet all applicable requirements.
Combined studies (medicinal product clinical trial + IVD performance study) are addressed, with specific guidance on sponsor responsibilities.

The Proposed IVDR Targeted Revision

The European Commission’s proposal (COM(2025) 1023), published in December 2025, includes changes that would directly impact performance studies if adopted:

Routine blood draw studies would no longer require prior authorisation, a significant simplification for many analytical and clinical performance studies.
CDx studies using exclusively leftover samples would no longer require mandatory notification.
Combined studies would benefit from a streamlined single-application process aligned with the Clinical Trials Regulation (EU) No 536/2014.

This proposal is still in the legislative process. The European Commission opened a feedback period until March 2026, and final adoption is not expected before late 2026 or 2027. Manufacturers should plan under current rules but stay informed of developments.

IVDR Transition Deadlines

For manufacturers relying on transitional provisions:

Class C devices: Notified Body application due by 26 May 2026.
Written agreement with Notified Body: Required by 26 September 2026 for Class C.
Legacy devices: Must continue to meet post-market surveillance and vigilance obligations under the IVDR, regardless of transitional status.

These deadlines are not flexible. Missing a milestone can mean loss of legal market access.

Summary: Performance Study Checklist for 2026

Before launching your IVD clinical performance study, confirm that you have addressed:

Planning phase:

Intended purpose clearly defined (manufacturer’s responsibility)
Regulatory pathway determined (Article 58(1), 58(2), 70, or other)
MDCG 2025-5 flowchart consulted
Clinical Performance Study Plan aligned with IVDR Annex XIII and ISO 20916:2024
Biostatistician engaged for sample size, endpoints, and SAP
National requirements checked for each Member State involved
Ethics committee submissions prepared

Execution phase:

Device version matches intended commercial product
Analytical performance established before or in parallel with clinical performance study
Data management plan in place with GDPR compliance
Good Study Practice (GSP) followed, not GCP
Substantial modification procedures defined
Safety reporting aligned with IVDR Article 76 and MDCG 2024-4

Reporting phase:

Clinical Performance Study Report (CPSR) prepared
Results integrated into Performance Evaluation Report (PER)
Post-Market Performance Follow-up (PMPF) plan developed
Documentation ready for Notified Body review

Frequently Asked Questions about IVD Clinical Trials

What is IVDR and how does it affect IVD clinical trials?

IVDR (In Vitro Diagnostic Regulation) is the EU regulatory framework that mandates clinical performance studies for IVDs. It requires documented evidence of analytical and clinical performance before market approval.

What are the main do’s for IVD clinical trial design?

Do establish clear study protocols aligned with IVDR guidelines, conduct ethical reviews early, use appropriate reference comparators, implement ISO 20916 standards, and document all decisions with traceability.

What are the critical don’ts in IVDR clinical studies?

Don’t skip ethics submissions, don’t underestimate sample size calculations, don’t use outdated reference materials, don’t ignore ISO 20916 requirements, and don’t delay documentation—regulators expect complete records.

Is ISO 20916 mandatory for IVD clinical performance studies?

ISO 20916 is the standard for clinical performance studies of in vitro devices. While referenced in IVDR, implementation depends on device class and intended use, but compliance significantly strengthens regulatory submissions.

How long does an IVD clinical trial typically take under IVDR?

Timeline varies by device complexity, study design, and patient availability—typically 6-18 months. Proper planning, early regulatory consultation, and avoiding common mistakes can accelerate approval timelines.

How MDx Can Help

Planning and executing an IVD clinical performance study under the current IVDR framework requires regulatory expertise, operational capability, and deep understanding of the evolving guidance landscape.

As a dedicated MedTech and IVD Contract Research Organisation (CRO), MDx supports manufacturers across the full study lifecycle, from protocol design and competent authority submissions to study conduct, monitoring, and reporting. Our team has hands-on experience with CDx companion diagnostics, NGS panels, and IVDs across Class B, C, and D classifications.

Whether you are launching your first IVDR performance study or managing a portfolio of legacy devices under transition pressure, we provide the expertise to navigate the process efficiently and avoid costly delays.

Explore our IVD clinical performance study services

Contact us to discuss your study

Planning your first IVD study?

Talk to our team.

Related Resources

This article was last updated in March 2026. The regulatory landscape for IVD clinical performance studies continues to evolve. For the latest information on IVDR requirements and how they affect your product, contact us.

Written by:

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.

Impact of the Health Services Pack on IVD manufacturers, labs/health institutions and sponsors of combined studies

January 13, 2026

Carlos Galamba

In this article, we analyze the Health Services Pack IVDR impact and its role in shaping future health regulations.

On 16 December 2025, the European Commission published a proposal to amend the EU Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) with targeted measures intended to reduce regulatory complexity, cost, and unpredictability while maintaining high safety standards.

This article focuses on IVDs under IVDR and the combined-study interface (drug–diagnostic and multi-legislation studies). It explains what the proposal says today, what it could change in practice, and how different stakeholders can prepare. It also recognizes that the text is still a proposal and may change during the ordinary legislative procedure in the European Parliament and Council.

Executive summary

What matters most for IVDR stakeholders.

If adopted largely as proposed, the package could materially affect how IVD stakeholders plan certification lifecycles, evidence generation, post-market obligations, in-house testing, and combined-study authorisations:

PRRC organisational burden would ease for SMEs relying on external PRRC support (availability requirement would soften; detailed qualification rules would be removed).
Certificate validity would shift from a fixed 5-year maximum to risk-based periodic reviews during the certificate lifecycle.
The proposal would support a broader evidence toolbox, including wider “clinical data” recognition and explicit promotion of New Approach Methodologies (including in silico testing).
Administrative burden would reduce via a narrower scope for summary documents and lower PSUR update frequency, plus longer timelines for certain vigilance reporting.
In-house testing under IVDR Article 5(5) would become more flexible, including (under IVDR) removing the “no equivalent device on the market” condition and explicitly bringing certain central laboratories supporting clinical trials into scope.
For combined studies, sponsors could submit a single application triggering a coordinated assessment aligned with the Clinical Trials Regulation framework.
Digitalisation would expand: digital EU Declarations of Conformity, more electronic submission, and electronic IFU for near-patient tests (among other measures).

The Commission frames these changes as a way to keep safety standards high while improving predictability, competitiveness, and innovation support; it cites €3–5 billion/year in cost savings at conservative estimates.

Key regulatory updates

PRRC flexibility for SMEs

Risk-based certificate validity

Broader clinical evidence

Reduced administrative burden

Flexible in-house testing (IVDR)

Streamlined combined studies

Expanded digitalisation

1) Context: why the Commission proposed a targeted IVDR/MDR revision

The Commission’s Q&A states that evaluation work identified shortcomings that negatively affect competitiveness, innovation, and patient care—pointing to inefficient coordination, divergent application of requirements, and procedures that are overly complex and costly.

The Commission describes the reform’s core objectives as:

Reduced administrative burden and stronger coordination
More proportionate requirements, especially for lower/medium risk devices and small patient populations
Support for innovation, including early expert advice and regulatory sandboxes
Greater predictability and cost-efficiency of certification, including enabling real-world evidence
Increased digitalisation across compliance tools and conformity assessment procedures

For IVDR stakeholders, the significance is not only the “what” but also the “how”: the proposal aims to make the system more predictable and less duplicative while leveraging EU-level expertise (including expert panels and EMA support).

2) Understanding Health Services Pack IVDR Impact: what it means for IVD manufacturers

2.1 PRRC: reduced organisational friction (especially for SMEs)

The proposal would:

Remove detailed qualification requirements for the Person Responsible for Regulatory Compliance (PRRC), and

Remove the requirement that SMEs using an external PRRC must have the PRRC “permanently and continuously” available; the PRRC would need to be available (without the “permanently and continuously” standard).

Why it matters: This could reduce structural overhead for smaller IVD manufacturers and for non-EU manufacturers using EU-based regulatory operating models. It may also reshape how manufacturers design PRRC coverage (internal vs external, shared services, outsourcing structures).

2.2 Certificates: from 5-year re-certification to risk-based periodic review

The proposal would remove the current maximum 5-year certificate validity and replace it with periodic reviews proportionate to device risk during the certificate’s validity period.

In addition, the proposal’s summary of certification changes includes:

Reduced systematic technical documentation assessment during surveillance activities (as summarised for certain IVD classes),
The ability for notified bodies to replace on-site audits with remote audits, and
Surveillance audits “only every two years” where justified by the absence of safety issues, plus unannounced audits “for-cause”.

Why it matters:
This is a structural shift in compliance planning—from a calendar-driven re-certification event to an ongoing lifecycle model that could be more data-driven. IVD manufacturers will likely need stronger “always audit-ready” systems and clearer change-control strategies.

Before and after comparison of IVDR requirements versus the Health Services Pack proposal, highlighting changes in PRRC availability, certificate validity, clinical evidence, PSUR, vigilance timelines, in-house testing, combined studies, and digitalisation.

2.3 Evidence toolbox: broader clinical data concepts and explicit support for in silico approaches

The proposal summarises multiple evidence-related changes, including:

A wider range of data qualifying as clinical data,
More flexible conditions for relying on clinical data from an equivalent device, and
Promotion of New Approach Methodologies such as in silico testing.

Why it matters for IVDs:
IVDR evidence expectations are often the pacing item for certification and market access—particularly for novel biomarkers, decentralised testing, and CDx. A broader toolbox could let manufacturers structure performance evaluation more efficiently, but it also puts more emphasis on robust justification: the proposal supports flexibility, not a “free pass.”

2.4 Summary documents and PSUR: targeted burden reduction

The proposal would:

Reduce the scope of devices that must have a summary of safety and (clinical) performance (SS(C)P) to those where the notified body must conduct technical documentation assessment—and remove the need for separate notified body validation of the draft summary.
Reduce the required PSUR update frequency, with notified body PSUR review integrated into surveillance.

For IVDR specifically, the proposal text also states that:

Manufacturers of class C and D devices would update the PSUR in the first year after the certificate is issued and every two years thereafter (or earlier in defined change situations).

Why it matters:
This change could reduce recurring workload—yet it will likely increase expectations that PSUR content is meaningful, well-argued, and operationally integrated into surveillance interactions.

2.5 Vigilance and cybersecurity: longer timelines for certain incidents, plus cyber reporting alignment

The proposal would extend the reporting timeline for certain serious incidents (those not linked to public health threats, death, or serious deterioration) to 30 days instead of 15.

It would also introduce a cybersecurity linkage:

Certain MDR/IVDR vigilance reports that also qualify as actively exploited vulnerabilities or severe incidents under the cyberresilience framework would be made available to national CSIRTs and ENISA; and
Manufacturers would have to report actively exploited vulnerabilities and severe incidents that do not qualify as “serious incidents” under MDR/IVDR to CSIRTs and ENISA through Eudamed;
Cybersecurity would be explicitly mentioned in Annex I general safety and performance requirements.

Why it matters for IVD manufacturers:
Cybersecurity is not only an “IT topic.” It increasingly affects performance, safety, vigilance, and field actions—especially for connected IVD instruments, software-driven diagnostics, and laboratory information system integration.

2.6 Digitalisation: eDoC, electronic submissions, eIFU for near-patient tests, and online sales information

The proposal includes:

Digital EU Declarations of Conformity,
More electronic submission of MDR/IVDR information,
Economic operators providing digital contacts in Eudamed,
Digital technical documentation and conformity assessment documentation, and
For IVDs, the ability for manufacturers of near-patient tests to provide electronic instructions for use.

It also introduces online-sales transparency requirements: essential device identification information and IFU information must be provided for online sales.

Why it matters:
This points toward a compliance ecosystem where document control, traceability, and market surveillance become more data-centric. Manufacturers will need disciplined digital governance to prevent inconsistency across channels.

3) What the proposal could change for labs and health institutions (IVDR Article 5(5) in-house)

The proposal would make in-house conditions more flexible, including:

Allowing the transfer of in-house devices when justified by patient safety or public health interests, and
Under IVDR, removing the condition that no equivalent device exists on the market.

It also explicitly adds central laboratories manufacturing and using tests exclusively for clinical trials into the scope of the in-house device exemption.

Why Health Services Pack IVDR matters
If adopted, this could significantly affect:

The role of hospital laboratories in innovation and continuity-of-care testing,
How health systems respond to unmet needs, niche populations, and rapidly evolving clinical practice, and
The operational models used to support clinical trials (including biomarker-driven trials and decentralised sample workflows).

What labs should plan
Recognising the proposal may change

Governance and documentation systems that can withstand scrutiny as “in-house” use expands in scope and visibility.
Contracting and quality interfaces between health institutions, trial sponsors, and central labs—especially where a lab’s “in-house” position interacts with trial requirements and sponsor expectations.

4) What the proposal could change for sponsors of combined studies (drug–diagnostic interface)

4.1 A single application with coordinated assessment (CTR-aligned pathway)

For combined studies involving medicinal products, medical devices, and/or IVDs, the proposal states that a sponsor may submit a single application triggering a coordinated assessment in accordance with the Clinical Trials Regulation (CTR), noting alignment with amendments anticipated via the Biotech Act.

Why it matters:
Sponsors running biomarker-driven programmes often experience friction at the interface between medicinal product trial authorisation processes and IVDR performance study requirements. A coordinated model—if implemented in a practical, predictable way—could materially improve planning across Member States.

4.2 Performance study burden reduction in defined scenarios

The proposal also states that:

Performance studies involving only routine blood draws would not require prior authorisation; and
Notification of performance studies on companion diagnostics using left-over specimens would be removed.

Why it matters:
This could affect study-start timelines, especially in multi-country settings where administrative sequencing often drives critical path. For sponsors, it may also change how they design sample strategies, feasibility, and site activation planning.

5) Practical implications of Health Services Pack IVDR Impact: how stakeholders can prepare while the text remains a proposal

Because the proposal may change during negotiations, stakeholders should avoid “over-implementing” assumptions. At the same time, most organisations can act now in ways that remain valuable under multiple legislative outcomes.

5.1 For IVD manufacturers (RA/QA and clinical/performance teams)

Focus now on “no-regret” preparedness:

Map your portfolio to where the proposal signals the biggest change: certificate lifecycle management, audit model (remote/on-site), and surveillance cadence.
Re-evaluate your evidence strategy so it can flex across clinical studies, literature, equivalence, and (where applicable) in silico methodologies—while keeping scientific validity and traceability strong.
Strengthen change control to align with the proposal’s intent to distinguish changes that require different levels of notified body interaction (including predetermined change control planning).
Upgrade vigilance and cybersecurity workflows so reporting pathways align with both vigilance obligations and the proposed cyber reporting linkages (CSIRTs/ENISA/Eudamed).
Digitise with discipline: ensure eDoC, digital IFU strategies, and online-sales content controls remain consistent and auditable.

5.2 For labs and health institutions

Review how in-house governance could evolve if the “no equivalent device” condition disappears and trial-supporting central labs fall clearly within scope.
Align in-house test lifecycle controls with quality expectations likely to increase as in-house scope expands in visibility and operational relevance.

5.3 For sponsors of combined studies

Build study-start strategies around the proposal’s direction of travel: a coordinated route for combined studies and reduced administrative hurdles for defined performance study scenarios.
Stress-test protocols for evidence coherence: regulators will still expect sponsor claims and IVD performance claims to align, even if administrative routes simplify.

6) Health Services Pack IVDR Impact and its potential global reach: what this could mean outside Europe

The Commission positions the EU as a global leader in medical device regulation and indicates the reform aims to make the sector more competitive globally.
It also explicitly links the proposal to reinforcing international cooperation, including participation in high-standard international cooperation and information-sharing mechanisms with reliable partners and strengthened uptake of international guidance.

For global manufacturers, that matters because EU compliance strategies often influence:

Global clinical evidence planning and dossier structuring, and
How manufacturers operationalise post-market surveillance and cybersecurity controls across regions.

(How much convergence happens in practice will depend on implementation and on how reliance mechanisms are used over time.)

FAQs

Is the Health Services Pack already law?

No. The Commission published a proposal on 16 December 2025. The text must go through the ordinary legislative procedure in the European Parliament and Council before any final legal changes take effect.

Will the proposal change IVDR certificate validity?

The proposal would remove the maximum 5-year certificate validity and replace it with risk-based periodic reviews while the certificate remains valid.

Does the proposal reduce PSUR update frequency under IVDR?

Yes. The proposal would reduce PSUR update frequency and integrate notified body PSUR review into surveillance. It also states class C and D PSUR updates would occur in the first year after certification and every two years thereafter (or earlier in defined cases).

Does the proposal change serious incident reporting timelines under IVDR?

Yes. For serious incidents not related to public health threats, death, or serious deterioration, the proposal would extend reporting timelines to 30 days instead of 15.

Does the proposal change IVDR in-house testing rules?

Yes. The proposal would make in-house conditions more flexible and, under IVDR, would remove the condition requiring “no equivalent device on the market.” It would also add certain central laboratories supporting clinical trials into scope.

How would the proposal affect combined studies?

The proposal states that sponsors could submit a single application for combined studies, triggering a coordinated assessment aligned with the Clinical Trials Regulation framework.

How can MDx CRO help you navigate Health Services Pack IVDR Impact effectively?

If you manufacture IVDs, run laboratory services, or sponsor combined studies, you will likely need to translate the proposal into:

A portfolio-level impact assessment (technical documentation, evidence strategy, and certification lifecycle planning), and
An operational plan for performance studies and combined-study submissions that remains robust even if the final text changes.

MDx CRO supports IVD manufacturers and sponsors across IVDR technical documentation, performance evaluation strategy, and combined study operational delivery (clinical operations + RA/QA alignment). The most effective next step is usually a short, structured gap-and-opportunity review tied to your portfolio and pipeline.

Need support?

We can assist you translating the Health Services Pack proposal into practical IVDR actions for your portfolio, studies, or lab activities.

Request a Free consultation

Written by:

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.

Industry Insights & Regulatory Updates

Advanced digital health technology showcasing human body and medical device integration for MedTech innovation.

EU AI Act and Medical Devices: What SaMD Developers Need to Know (2026)

FDA QMSR: How the 2026 Regulation Shift Transforms MDSAP Audits and FDA Compliance Inspections

High-tech European Parliament building with EU flag, modern glass architecture, representing advanced government infrastructure and innovation.

Navigating the IVDR CDx Certification Pathway

iso 20916 2024 ivdr harmonization ivd studies Detailed image of female researcher examining samples through a microscope in a modern laboratory, demonstrating advancements in MedTech innovation and research in healthcare technology.

ISO 20916:2024 What You Need to Know for Clinical Performance Studies in 2026

IVDR Lab Readiness: Step-by-Step Transition Checklist

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

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.
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.
No Grandfather Clause
The proposal does not exempt existing LDTs. All LDTs (old and new) must eventually comply.
Test Categories Exempt from Enhanced Oversight
Certain test types, including forensic tests and HLA assays, are proposed for exemption.
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

CEO

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

Industry Insights & Regulatory Updates

EU AI Act and Medical Devices: What SaMD Developers Need to Know (2026)

FDA QMSR: How the 2026 Regulation Shift Transforms MDSAP Audits and FDA Compliance Inspections

Navigating the IVDR CDx Certification Pathway

ISO 20916:2024 What You Need to Know for Clinical Performance Studies in 2026

IVDR Lab Readiness: Step-by-Step Transition Checklist

MDx: Your Dedicated CRO for IVD Clinical Studies in the EU

August 24, 2023

Introduction

In the rapidly evolving world of in vitro diagnostics (IVD), manufacturers are increasingly understanding the need for rigorous clinical performance studies. Such studies form the backbone for ensuring the safety, efficiency, and overall market readiness of IVD devices. With the European Union’s (EU) stringent regulatory environment, conducting these studies requires expertise and precision. That’s where MDx CRO, a trusted name in IVD Contract Research and regulatory consulting, stands out.

Why are IVD Clinical Studies Imperative?

Evidence-based Decision Making: Clinical performance studies furnish the data that can prove the diagnostic accuracy, precision, and utility of IVD devices. They help manufacturers refine their offerings and justify their product claims.
Regulatory Adherence: Ensuring compliance with the EU’s In Vitro Diagnostic Regulation (IVDR) and standards like ISO 20916 is non-negotiable. Clinical studies often form the bedrock in gaining these credentials and opening up the European market.

Navigating the Challenges with MDx CRO

Whether you’re a fledgling startup or an established IVD giant, challenges like site selection, study design, effective monitoring, and regulatory adherence can be daunting. This is where MDx CRO can be your guiding light:

Proven Expertise: With its legacy in the IVD realm and former Notified Body experts on board, MDx CRO offers unparalleled insights into effective study design, ensuring manufacturers derive actionable insights every time.
Network of Clinical Sites: Owing to its years in the industry, MDx CRO has built strong affiliations with leading clinical sites, guaranteeing timely and efficient study conduct.
Regulatory Insight: Navigating the IVDR and ISO 20916 maze becomes simpler with MDx CRO’s regulatory consulting wing, which ensures manufacturers always stay on the right side of the law.
End-to-End Monitoring: With a keen focus on detail, MDx CRO ensures every study stays on track, protocols are maintained, and data integrity remains uncompromised.

Why MDx CRO?

Simply put, MDx CRO isn’t just a service provider – it’s a partner in your IVD journey. Our seasoned team understands the unique challenges IVD manufacturers face, making them an indispensable asset in your product’s journey from concept to the European market.

Conclusion

IVD clinical studies, while challenging, present a golden opportunity to IVD manufacturers to rigorously validate their product’s claims. In the intricate web of EU regulations, manufacturers need more than just expertise; they need a partner. And who better than MDx CRO, which has consistently demonstrated excellence in study design, monitoring, and ensuring complete regulatory compliance? Choose MDx CRO, and let’s work together to bring transformative and reliable IVD devices to the EU market.

FAQs about IVD Clinical Studies and MDx CRO:

What are IVD Clinical Studies?
- IVD clinical studies refer to rigorous research and evaluations conducted to determine the safety, efficiency, and overall performance of in vitro diagnostic (IVD) devices.
Why are IVD Clinical Studies important in the EU?
- The EU has stringent regulatory requirements. IVD clinical studies provide the necessary evidence to support product claims, ensuring compliance with the EU’s In Vitro Diagnostic Regulation (IVDR) and international standards like ISO 20916.
What challenges can manufacturers expect while conducting IVD studies in the EU?
- Manufacturers may face challenges like site selection, creating an effective study design, regular study monitoring, and ensuring compliance with EU regulations and standards.
How does MDx CRO help with these challenges?
- MDx CRO offers expertise in study design, has affiliations with top clinical sites, provides regulatory consulting for EU standards, and ensures end-to-end study monitoring to maintain the quality and integrity of data.
Is MDx CRO suitable for both startups and established manufacturers?
- Absolutely! Whether you’re a startup entering the IVD market or a seasoned manufacturer, MDx CRO’s tailored solutions cater to the unique needs of every client.
How does MDx CRO ensure compliance with the IVDR and ISO 20916?
- MDx CRO boasts a regulatory consulting wing with deep knowledge of IVDR and ISO 20916, ensuring manufacturers receive accurate guidance and assistance throughout their IVD device’s journey to the market. Our team of former Notified Body experts on board help design studies that meet CE mark expectations
What advantages does MDx CRO offer in terms of site selection for IVD studies?
- With its extensive experience and industry connections, MDx CRO has built relationships with leading clinical sites for a variety of technologies and clinical applications, ensuring timely and efficient study initiation and execution.
How does partnering with MDx CRO impact the success rate of IVD devices in the EU market?
- With MDx CRO’s comprehensive services, from design to monitoring and regulatory guidance, manufacturers enhance their chances of a successful and compliant IVD product launch in the EU.
Where can I learn more about MDx CRO’s success stories or case studies?
- It’s best to reach out to MDx CRO directly or visit our website for detailed testimonials, case studies, and more insights into our work.

Written by:

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.

Industry Insights & Regulatory Updates

Researchers conducting advanced medical technology experiments in a laboratory setting, focusing on clinical research and innovative solutions for healthcare.

Making IVDR Work in Combined Studies: Scientific & Operational Lessons from 40+ Programs

Automated manufacturing of medical vials in a cleanroom environment, highlighting MedTech advancements by MDX for medical device and pharmaceutical industries.

ISO 14155:2026 What’s Changed and What It Means for Your Clinical Investigation

Close-up of a scientist handling a test tube with DNA strands and digital medical data overlays, emphasizing advanced medical technology and research.

Portugal’s New Clinical Trials Law No. 9/2026: What Sponsors Need to Know

A tall stack of organized medical device documentation and regulatory papers against a blue background, emphasizing compliance and regulatory standards in MedTech.

IMDRF Draft N91 2026: New Clinical Evidence Requirements for IVDs Explained

EU AI Act and Medical Devices: What SaMD Developers Need to Know (2026)

What is the Regulatory Process for IVD in Europe?

May 10, 2023

What is the regulatory process for IVD in Europe, and which are the most important aspects of it? Continue reading to learn more.

The In Vitro Diagnostic (IVD) market in Europe is regulated by a complex framework, and understanding the regulatory process for IVD is crucial for manufacturers looking to bring their products to market. With the implementation of the In Vitro Diagnostic Regulation (IVDR) in 2022, new requirements and conformity assessment routes have been introduced.

In this article, we will discuss the regulatory process for IVD in Europe, highlighting the importance of IVD consultancy and the role MDx CRO can play in developing technical documentation and managing clinical performance studies for IVDs.

1. Overview of the In Vitro Diagnostic Regulation (IVDR)

The IVDR (EU) 2017/746 came into full effect in May 2022, replacing the In Vitro Diagnostic Directive (IVDD) 98/79/EC. The regulation aims to improve patient safety and the performance of IVDs by introducing more stringent requirements for manufacturers. Some of the significant changes introduced by the IVDR include:

A risk-based classification system for IVD devices
Strengthened requirements for clinical evidence
Increased scrutiny of the IVD technical documentation
Increased post-market surveillance (PMS) requirements

2. Risk-based Classification of IVDs

The IVDR introduces a new risk-based classification system, dividing IVDs into four classes (A, B, C, and D) based on their potential risk to patients and public health. This classification system is more aligned with the global risk-based classification approach and helps determine the appropriate conformity assessment route for each IVD device.

3. Conformity Assessment Routes

Under the IVDR, manufacturers are required to follow specific conformity assessment routes based on the classification of their IVD device. The conformity assessment routes include:

Self-certification for Class A non-sterile devices
Assessment by a notified body for Class A sterile, Class B, C, and D devices

Manufacturers must choose a notified body designated under the IVDR to assess their device’s conformity. The notified body will review the technical documentation, conduct a quality management system (QMS) audit, and issue an EU Technical Documentation Assessment Report and an EU QMS Certificate, which are essential for obtaining a CE mark.

4. Technical Documentation

Technical documentation is a crucial aspect of the regulatory process for IVD in Europe. Under the IVDR, manufacturers must maintain comprehensive technical documentation that demonstrates the safety, performance, and compliance of their IVD device. The technical documentation should include:

Device description and specifications
Information about the device’s design and manufacturing process
Pre-clinical, analytical and clinical performance data
Labelling and instructions for use
Risk management documentation
QMS documentation
Post-market surveillance and vigilance data

5. Clinical Evidence and Performance Studies

The IVDR emphasizes the importance of clinical evidence in demonstrating the safety and performance of IVD devices. Manufacturers must conduct clinical performance studies to generate robust clinical evidence that supports their device’s intended purpose, clinical performance claims, and overall safety. The clinical evidence should be periodically updated as part of the post-market surveillance process.

6. Post-Market Surveillance (PMS)

Under the IVDR, manufacturers are required to establish a comprehensive PMS system that monitors the safety, performance, and effectiveness of their IVD device throughout its lifecycle. The PMS system should be capable of identifying and addressing potential risks, non-conformities, and adverse events.

Manufacturers must also establish a Periodic Safety Update Report (PSUR) to provide a summary of the PMS data and any necessary corrective actions.

7. The Role of IVD Consultancy and CRO

Navigating the regulatory process for IVD in Europe can be a complex and time-consuming task. Partnering with an experienced IVD consultancy can significantly streamline the process, ensuring compliance with the IVDR and facilitating a successful market entry. IVD consultancies, such as MDx CRO, offer invaluable support in various areas, including:

Developing technical documentation
Managing clinical performance studies
Designing and implementing a robust QMS
Guiding through the risk management process
Assisting with post-market surveillance and vigilance activities

8. How MDx CRO Can Help

MDx CRO is a leading IVD consultancy and IVD CRO that specializes in helping manufacturers navigate the regulatory process for IVD in Europe. Our team of experts has extensive experience in developing technical documentation and managing clinical performance studies for IVDs, ensuring compliance with the IVDR.

We offer the following services:

Technical documentation development: Our team will work closely with you to create comprehensive technical documentation that demonstrates your IVD device’s safety, performance, and compliance with the IVDR.
Clinical performance study management: We design and manage clinical performance studies tailored to your IVD device, generating robust clinical evidence that supports your device’s intended purpose and clinical performance claims.
Post-market surveillance support: We assist manufacturers in establishing a comprehensive PMS system, ensuring continuous monitoring of the safety and performance of your IVD device throughout its lifecycle.

Regulatory Process for IVD: Conclusion

Understanding the regulatory process for IVD in Europe is crucial for manufacturers looking to bring their products to market successfully. The IVDR has introduced new requirements and conformity assessment routes that manufacturers must comply with to ensure patient safety and the performance of their IVD devices.

Partnering with an experienced IVD consultancy like MDx CRO can significantly streamline the process, providing invaluable support in developing technical documentation, managing clinical performance studies, and ensuring compliance with the IVDR.

Are you in need of expert guidance and support to navigate the regulatory process for IVD in Europe? Contact MDx CRO today to learn more about our IVD consultancy services and how we can help you successfully bring your IVD device to market.

FAQs

What are the key changes introduced by the In Vitro Diagnostic Regulation (IVDR) in Europe?

The IVDR has introduced several significant changes to the regulatory process for IVD in Europe. Some of the key changes include:

A new risk-based classification system for IVD devices, dividing them into four classes (A, B, C, and D) based on their potential risk to patients and public health.
More stringent requirements for clinical evidence, emphasizing the importance of conducting clinical performance studies to generate robust clinical data.
Increased scrutiny of the IVD technical documentation to ensure the safety, performance, and compliance of IVD devices.
Enhanced post-market surveillance (PMS) requirements, mandating manufacturers to establish a comprehensive PMS system that monitors the safety and performance of their IVD devices throughout their lifecycle.

How can an IVD consultancy like MDx CRO help manufacturers navigate the regulatory process for IVD in Europe?

MDx CRO, a leading IVD consultancy, offers expert guidance and support to help manufacturers navigate the complex regulatory process for IVD in Europe. Our services include:

Developing technical documentation that demonstrates the safety, performance, and compliance of IVD devices according to the IVDR requirements.
Designing and managing clinical performance studies tailored to the specific IVD device, generating robust clinical evidence to support its intended purpose and clinical performance claims.
Assisting with the establishment of a comprehensive post-market surveillance system, ensuring continuous monitoring and addressing any potential risks, non-conformities, or adverse events throughout the device’s lifecycle.

By partnering with MDx CRO, manufacturers can ensure compliance with the IVDR and successfully bring their IVD devices to the European market.

Industry Insights & Regulatory Updates

Making IVDR Work in Combined Studies: Scientific & Operational Lessons from 40+ Programs

ISO 14155:2026 What’s Changed and What It Means for Your Clinical Investigation

Portugal’s New Clinical Trials Law No. 9/2026: What Sponsors Need to Know

IMDRF Draft N91 2026: New Clinical Evidence Requirements for IVDs Explained

EU AI Act and Medical Devices: What SaMD Developers Need to Know (2026)