IVDR Performance Studies and the ISO 20916:2024 Revision

April 2, 2024

ISO 20916: Introduction

ISO 20916, “Clinical performance studies using specimens from human subjects – Good study practice” was first published in 2019 and recently released as EN ISO 20916:2024 (European Standard) at the end of March 2024, harmonizing IVDR Performance Studies with this latest revision.

In the rapidly evolving landscape of in vitro diagnostic (IVD) medical devices, maintaining the highest standards of safety and performance is paramount. ISO 20916 stands as a cornerstone in this endeavor, providing a framework for the quality and reliability of IVDs used in clinical performance studies employing human subject specimens.

This standard encapsulates comprehensive practices for planning, designing, conducting, recording, and reporting clinical performance studies for IVD devices. It lays down the foundational principles and specifies general requirements aimed at assessing clinical performance and safety for regulatory purposes. It has been meticulously designed to ensure that IVDs meet stringent criteria, thereby safeguarding public health and enhancing patient outcomes. It is intended to aid regulatory compliance, ensuring studies yield robust, ethical, and reliable results.

MDx will host a live free webinar on “Preparing for IVDR Clinical Performance Studies under ISO20916 and the new annex ZA” on the 30th April 2024 at 5pm CET. Register here.

The importance of Annex ZA of ISO 20916:2024 in IVDR performance studies

At the end of March 2024, the IVD community witnessed a significant milestone with the publication of a new revision of ISO 20916 which harmonizes IVDR performance studies. While the standard was already referenced in the text of the IVDR, this revision is particularly notable for the inclusion of Annex ZA, which finally harmonizes the standard with the In Vitro Diagnostic Regulation (IVDR) (Regulation (EU) 2017/746).

This harmonization of performance studies marks a critical step in aligning the standard with the comprehensive requirements set forth by the IVDR, thus facilitating a more streamlined regulatory pathway for IVD manufacturers. The significance of Annex ZA cannot be overstated. It bridges the gap between ISO 20916 and the IVDR, providing a clear and actionable framework for manufacturers to achieve compliance.

The text of ISO 20916:2019 has been approved by CEN (the European Committee for Standardization) as EN ISO 20916:2024 without any modification. This inclusion is a strategic enhancement, reinforcing the standard’s relevance and applicability in the regulatory landscape.

Note: As of the date this article was written, the official recognition of ISO 20916:2024 as an IVDR harmonized standard for clinical performance studies in the European Union’s Official Journal was awaiting confirmation.

Success in IVD Clinical Performance Studies with MDx CRO

At MDx CRO, we navigate the complexities of IVDR and the latest ISO 20916 revision for in vitro diagnostic (IVD) studies with unmatched expertise. Our commitment to rigorous clinical operations ensures that every clinical performance study meets all regulatory standards, incorporating strategic risk management and adaptability for maximum compliance and integrity.

Partnering with us offers manufacturers a significant advantage, rigorously evaluating IVDs to ensure adequate performance and safety, a critical component of regulatory approvals.

Choose MDx CRO for excellence in IVD clinical performance studies, driving success and enhancing patient outcomes. Contact us for a discussion today!

Highlights from Annex ZA include:

Presumption of Conformity: Compliance with the normative clauses of ISO 20916, as specified in Table ZA.1, confers a presumption of conformity with the corresponding GSPRs of the IVDR. This presumption is a testament to the robustness of the standard in meeting regulatory expectations.
Definition Clarification: Where differences arise between definitions in ISO 20916 and those in the IVDR, Annex ZA ensures clarity by highlighting these differences. The annex prioritizes the definitions set out in the IVDR, underscoring the regulation’s primacy.
Risk Management Alignment: The annex emphasizes the necessity of aligning the risk management process in EN ISO 20916:2024 with the IVDR. This alignment ensures that risks associated with IVDs are “reduced as far as possible”, in accordance with the regulation’s stringent requirements. In addition, ISO 20916 does not include foreseeable misuse in the risk management process, as required by IVDR.
Manufacturer’s Policy on Acceptable Risk: Annex ZA clarifies that the manufacturer’s approach to determining acceptable risk must adhere to specific GSPRs (i.e. 1, 2, 3, 4, 5, 8, 10, 11, 13, 15, 16, 17, 18 and 19) outlined in the IVDR. Furthermore, when reducing risks, sponsors, CROs, manufacturers and other stakeholders should note that while ISO 20916 does not include user training as a risk reduction measure, this is indeed allowed under IVDR.

Synergies between ISO 20916 and IVDR:

IVDR clinical performance parameters: Generally aligned between ISO 20916 and IVDR, however note that ISO 20916 does not mention “expected values in normal and affected populations” as a clinical performance parameter.
Ethical considerations: Generally aligned but ISO 20916 is a lot more prescriptive when compared to IVDR, defining ethical considerations and responsibilities for all parties involved, including principal investigators and sponsors.
Measures to minimise bias in study design: ISO 20916 further defines specific areas that should be considered when avoiding bias, including population bias, bias in the test protocol, bias in the reference measurement procedure, etc.
Site qualification: ISO 20916 provides a more detailed framework for site qualification, covering several criteria, including investigator qualifications, adequate resources and facilities, validated equipment , lab’s quality management system etc.
Clinical performance study report (CPSR): ISO 20916 is in general a lot more prescriptive on the contents of the clinical performance study report. Additional requirements are provided for interventional and other performance studies involving risks to the subjects.
Comparator devices used in an IVD performance study: Generally aligned, but ISO 20916 defines further how comparator IVDs should be listed, including their commercial name, manufacturer and catalogue number for example.
Investigators Brochure (IB) for Annex XIV studies: both IVDR and ISO 20916 are aligned. Annex C in ISO 20916 is dedicated to the contents of the IB. In addition ISO 20916 is a lot more prescriptive than IVDR on requirements related to risk management and risk-benefit analysis that need to be described in the CPSP and IB.

Differences to be aware of:

Differences in Annex XIV studies (and IVDR article 58): The definitions of an Annex XIV study in IVDR (i.e. interventional and other performance studies involving risks to the subjects) are different from ISO 20916. Although Annex ZA considers both the standard and regulation to cover the same elements and therefore being aligned, the description of what is in essence an Annex XIV study is different when we look at the detail. For example, the IVDR recognizes surgically invasive sample taking as being an Annex XIV study, while ISO 20916 does not use this terminology.
Adverse events: Although both IVDR and ISO 20916 are considered aligned, there are differences in the categorization of adverse events occurring in clinical performance studies. ISO 20916 provides two main types of events: non-device-related and device-related, and further categorizes this into non-serious and serious, anticipated, and non-anticipated. The IVDR is not as prescriptive in this area.
Clinical performance study plan (CPSP): ISO 20916 is more prescriptive on the specimen details to be listed in the CPSP, including their storage. In addition, ISO 20916 does not require reference to the current state of the art in diagnosis and/or medicine, whereas this is a requirement from IVDR. Last but not least, ISO 20916 has specific requirements for the CPSP synopsis.
Monitoring plan: ISO 20916 is a lot more prescriptive on the requirements for the monitoring plan, including qualification and training of monitors. According to ISO 20916 sponsors can also develop a rationale for remote monitoring. In addition, whereas IVDR requires that sponsors appoint a monitor independent of the investigation site, this point is not mandated by ISO 20916.
Informed Consent: A lot more detail is provided in ISO 20916 when compared to IVDR. The standard offers a detailed framework for obtaining informed consent.

Who Benefits from EN ISO 20916:2024?

Manufacturers of in vitro diagnostic medical devices
In vitro diagnostic clinics and laboratories
Test centres for in vitro diagnostic medical devices
Regulatory authorities
IVDR Notified Bodies
IVD Clinical research organizations (CROs)
Investigators and sponsors

Advantages of Adopting EN ISO 20916 for IVD Performance studies

Robust Results: It ensures high-quality, accurate, and reliable data generation, pivotal for safe healthcare decisions.
Ethical Standards: It upholds the rights, safety, dignity, and well-being of study subjects.
Study Planning and Conduct: It facilitates the meticulous planning and execution of IVD performance studies, ensuring regulatory and ethical compliance alongside scientific validity.
Compliance and Clarity: It provides a framework for compliance with IVDR, clarifying roles and responsibilities of all parties involved.
Risk Management: It emphasizes subject safety, especially regarding specimen collection risks, and ensures data integrity.

Implications for IVD Performance Studies and CRO Services

The integration of ISO 20916 with the IVDR, highlighted by the inclusion of Annex ZA, significantly transforms IVD clinical performance studies and CRO operations. This crucial alignment demands a comprehensive revision in study design, execution, and reporting methodologies, highlighting the importance of compliance with the unified ISO 20916 and IVDR standards. It emphasizes the need for robust quality and risk management systems and ethically responsible study development.

This evolution signifies more than standard adherence; it represents a commitment to elevating IVD performance and efficacy in line with the highest EU regulatory standards. It requires IVD stakeholders, including CROs, sponsors and manufacturers, to deeply understand and agilely apply these standards, not only for compliance but to set new quality and safety benchmarks in diagnostics.

This commitment is fundamental to advancing patient care and public health, marking a significant step forward in regulatory compliance and industry excellence.

Since its foundation, MDx CRO has consistently used ISO 20916 as the benchmark for all our IVD clinical performance studies. The release of Annex ZA and its harmonization with IVDR reinforces our status as the leading CRO for IVD clinical performance studies.

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.

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FDA Laboratory Developed Tests (LDTs) Regulation

October 4, 2023

FDA’s new LDT regulation underscores the vital role of IVD CROs in compliance and safety. Phased over four years without grandfathering, it highlights the necessity for IVD CROs’ regulatory expertise and their key role in aligning LDTs with stringent standards, marking a significant shift in the IVD landscape.

Introduction

The Food and Drug Administration (FDA) recently released a groundbreaking proposed rule on September 29, 2023, aiming to transform its existing approach toward Laboratory-Developed Tests (LDTs). This paradigm shift directly impacts In Vitro Diagnostic products (IVDs) and their regulation. The proposed rule presents a layered plan for LDTs, phasing out FDA’s longstanding policy of enforcement discretion. For stakeholders in the IVD sector, including clinical laboratories and LDT manufacturers, the implications of this proposed rule are monumental.

Key Points to Consider as the FDA regulates LDTs

Modification to IVD Definition: The FDA aims to explicitly categorize LDTs as IVDs within the scope of 21 CFR Part 809.3, thus making them subject to FDA’s medical device regulations, including premarket review.
Phased Implementation: The FDA proposes to gradually roll back its enforcement discretion policy for LDTs, segmenting the regulatory shifts over five distinct stages across a four-year period.
No Grandfather Clause: Unlike previous considerations, the new proposal doesn’t plan to “grandfather” existing LDTs. Public commentary on this subject is invited.
Test Exemptions: Specific test types, such as forensic and human leukocyte antigen tests, are marked for exemption from enhanced regulatory oversight.
Comment Period: Stakeholders have until December 4, 2023, to submit their feedback on the proposed rule.

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

These IVDs also fall under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). LDTs, a specialized category within IVDs, have long operated under enforcement discretion, essentially receiving less stringent oversight. This approach historically aligned with the perception of LDTs as low-risk products, but the proposed rule acknowledges the evolved complexity and widespread use of LDTs in modern healthcare.

The Evolving Landscape of LDTs

Over the past 50 years, the role of LDTs has changed dramatically, making the FDA regulation of Laboratory Developed Tests increasingly crucial. Their growing prevalence and the technical sophistication involved have prompted calls for stronger regulatory oversight. These significant developments have culminated in the FDA’s renewed perspective on LDTs. Shedding its previous stance of general enforcement discretion, the FDA Laboratory Developed Tests Regulation now aims to redefine LDTs broadly, addressing potential regulatory gaps and emphasizing the need for robust public health protection.

The Road Ahead: Implications and Recommendations

The phased implementation approach impacts various aspects of medical device regulation:

Medical Device Reporting: Will be the first area where enforcement discretion will cease.
Quality Systems: Expected to come under scrutiny three years after the final policy is published.
Premarket Review: To be phased in 3.5 to four years after the final policy, impacting high-risk IVDs first and then trickling down to moderate-risk and low-risk IVDs.

Given these imminent changes, clinical labs offering LDTs must prepare for enhanced regulatory compliance and for increased FDA regulation of Laboratory developed tests. These labs should develop protocols for both analytical and clinical validity, ensuring alignment with new regulatory expectations.

Synergies with the EU’s IVDR roll-out

In Europe, a similar regulation, the In Vitro Diagnostic Regulation (IVDR), is being phased in, emphasizing the importance of compliance for in house developed tests. Under IVDR, laboratories must ensure that their Technical Documentation and Quality Management System are up-to-date and comply with the regulation and the national law. Failure to comply with the IVDR can result in serious consequences, including fines, loss of accreditation, and even closure of the laboratory.

Furthermore, laboratories that develop in-house IVDs will be required to comply with similar requirements for manufacturing as commercial IVD manufacturers. This means that laboratories must ensure that their IVDs meet high standards for safety and performance, which can only be achieved through rigorous testing and validation.

It is important to note that the IVDR specifically includes in-house developed tests, including LDTs and CE marked IVDs modified by laboratories. If an equivalent CE marked device is available on the market or IVD product is manufactured at an industrial scale, the laboratory cannot use exemption for LDT´s provided in the IVDR (Article 5.5) and must CE mark the IVD. MDx CRO has recently published an article assessing the impact of the IVDR on LDTs.

Conclusion: An Industry in Transition

As specialists in quality, regulatory, and clinical consultancy focused on IVDs, MDx CRO advises stakeholders to take proactive measures in anticipation of these sweeping regulatory changes. Judicial challenges and public feedback could alter the timeline for the FDA to start regulating LDTs, but there’s no doubt that enhanced regulation of LDTs is on the horizon, already in full force in Europe.

Comments on the Proposed FDA Rule should be submitted by December 4, 2023, to help shape this crucial regulatory development. It is an opportune time for the industry to engage in open dialogue and to prepare for the inevitable changes that lie ahead.

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.

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Companion Diagnostics IVD Consultancy within the EMA Framework: Comprehensive Guidance

August 8, 2023

The field of companion diagnostics IVD (CDx) represents a confluence of technological innovation, regulatory compliance, and patient care. As personalized medicine becomes an integral part of healthcare, the regulatory framework governing CDx, including the In Vitro Diagnostic Medical Devices Regulation (IVDR), has become more complex. This scenario calls for a specialized companion diagnostics consultancy. MDx CRO is at the forefront of this arena, offering expertise and guidance in the process for CDx consultation with the European Medicines Agency (EMA), Notified Body preparation and IVDR compliance within the European Union (EU).

Companion Diagnostics IVD and their Role

CDx are in vitro diagnostic (IVD) tests designed to provide information that is essential for the safe and effective use of a corresponding medicinal product. Their applications could include:

Identifying patients who are most likely to benefit from a particular therapeutic product.
Determining patients’ suitability for specific treatments.
Monitoring responses to ongoing treatments.

The Impact of IVDR on Companion Diagnostics

The IVDR sets out robust legal requirements for in vitro diagnostic medical devices, including CDx. Key aspects include:

Enhanced Patient Safety: Ensuring the quality and reliability of CDx IVDs.
Stricter Oversight: Increased scrutiny of the CDx development and approval process. Unlike the previous directive, CDx now require conformity assessment by a Notified Body, an independent organization designated to assess the compliance of medical devices and in-vitro diagnostics. In addition, CDx are also assessed by a medicines authority, most likely the EMA (European Medicines Agency), but a competent authority could also be involved .
Comprehensive Technical Documentation: Increased clinical evidence requirements are particularly notable in the IVDR. MDx CRO can help CDx manufacturers and their drug partners gather the necessary data to support their CDx application. This data may include clinical trial data (clinical performance data), analytical data, and safety data. Manufacturers must provide robust clinical evidence to demonstrate the performance, safety, and clinical utility of the CDx.

There are a number of other factors that can affect the approval process for CDx in the EU. These factors include:

The availability of data: Both the Notified Body and the EMA will need to have access to data from clinical trials that demonstrate the safety and effectiveness of the CDx.
The complexity of the CDx: The more complex the CDx, the more difficult it will be to assess its safety and effectiveness.
The novelty of the CDx: If the CDx involves new technologies or indications, the EMA and the Notified Body will need to take a more cautious approach to its approval. Different scenarios will play a role on the extent of scrutiny involved, including co-developed CDx scenarios, follow-on CDx, and CDx already on the market under the old IVD directive.

Understanding the EMA Companion Diagnostics Consultation Procedure

The consultation procedure is initiated by the notified body when it receives an application from a CDx manufacturer. The medicinal product involved could be a medicine already authorised for marketing in the EU or a medicine undergoing approval. Aligning drug and diagnostic development processes can help to ensure that the results of the clinical trials are accurate and reliable, and that the medicine is safe and effective when used with the CDx.

Aligning timelines in the drug and diagnostic (CDx) development process can help to ensure that the clinical trials for the medicine are conducted in a way that is consistent with the intended use of the CDx.

Upon application for a CDx IVD approval, the notified body will submit a letter of intent to the EMA, along with a technical dossier that describes the CDx and the medicinal product.

The EMA will then appoint a rapporteur, who will be responsible for reviewing the technical dossier and issuing a scientific opinion on the suitability of the CDx for use with the medicinal product. The rapporteur will also consider the views of any other interested parties, such as the applicant for the medicinal product, the manufacturer of the CDx, and patient groups.

The EMA will provide its scientific opinion on the CDx aspects that relate to the medicine to the notified body. The notified body will then use the EMA’s opinion to make a decision on whether to grant the CE mark to the CDx, in accordance with the regulatory requirements of the in vitro diagnostics regulation (EU IVDR).

EMA procedure timetables play a major role in the success of the consultation and turn around times for responses can be extremely short. Manufacturers should factor this in as they plan for their CDx submissions. There is the possibility to request a pre-submission meeting which will include representatives from Notified Bodies, EMA and could also include the drug manufacturer – this is used strictly to align on procedural and timing considerations (it is not used to provide feedback on study design or the content of the technical documentation).

One of the key documents used in the consultation and submitted by the notified body to the EMA is the SSP (Summary of Safety and Performance). The EMA expects manufacturers to use the SSP template provided in MDCG 2022-9. A lot more detail is expected in the SSP when compared to the information provided in the IFU. For example, detail on concordance studies is needed, particularly for co-developed CDx when different versions of a diagnostic have been used throughout the clinical development program.

MDx CRO: Your Partner in Companion Diagnostics Consultancy

Our companion diagnostics consultancy services encompass every stage of development, approval, and post-market surveillance:

Guidance on IVDR Requirements: In-depth support in understanding and meeting the specific demands of IVDR as they relate to CDx. MDx CRO can help a diagnostics company identify the specific requirements that apply to its CDx. For example, the requirements for a CDx that is intended to assess a patient’s suitability for treatment may be different from the requirements for a CDx that is intended to be used to monitor a patient’s response to treatment.
Preparation for Notified Body Assessment: Tailored strategies for successful assessment of a CDx under the IVDR: Assistance with compiling and submitting the necessary technical documentation and quality related documents.
Providing training to the manufacturer’s staff: MDx CRO can provide training to the manufacturer’s staff on the EMA’s requirements for CDx, as well as the notified body’s assessment process and expectations. This training will help to ensure that the manufacturer’s staff are prepared to answer any notified body questions and increase chances of success.
Stakeholder Communication: Facilitating communication with all relevant parties.
Global Perspective: Navigating international considerations for CDx in multi-country studies.
Post-Market Support: Focused on maintaining the highest standards through ongoing compliance monitoring with IVDR and other regulatory requirements. This includes implementing strong post-market surveillance processes and Post-Market Performance Follow-up (PMPF) evaluations, monitoring the CDx’s performance in real-world clinical settings, tracking and analyzing adverse events related to CDx usage, and conducting ongoing studies to evaluate the long-term impact and effectiveness of the CDx.

Why MDx CRO for Companion Diagnostics IVD Consultancy?

Expertise: Our in-depth knowledge of CDx, IVDR, and EU regulations offers unparalleled support.
Collaboration: Working closely with clients, we tailor our approach to meet specific needs.
Efficiency: Our insights and guidance save valuable time and resources, simplifying complex regulatory pathways.
Commitment: Our dedication to excellence, patient safety, and innovation sets us apart.

Navigating the multifaceted world of companion diagnostics in the EU, with the added complexity of IVDR, requires a dedicated and skilled partner. MDx CRO stands ready to be your guide in this critical journey, ensuring alignment with all regulatory standards. Reach out to explore how our companion diagnostics consultancy can be the key to unlocking your CDx potential in the EU’s dynamic regulatory environment.

FAQs

Q: What is a co-developed Companion Diagnostics in the context of EMA consultation?

A: A co-developed CDx is a device developed alongside a medicinal product for either initial authorization or a change of indication. This can include development during a pivotal clinical trial or a bridging study, with sufficient documentation to ensure performance alignment.

Q: How does a follow-on CDx differ from a co-developed CDx?

A: A follow-on CDx seeks the same indication as the original CDx but is not developed in parallel with the medicinal product. The follow-on CDx targets the same biomarker but may not be based on the same technology. It should be highly comparable to the original in performance, safety, and effectiveness.

Q: What documentation is required for a follow-on CDx?

A: Sufficient documentation must be provided for a follow-on CDx to prove that its analytical performance is comparable to the original CDx and that there’s no impact on clinical performance incompatible with the safe and effective use of the medicinal product.

Q: How are devices transitioning from IVDD to IVDR handled?

A: Devices initially marketed under Directive 98/79/EC (IVDD) that transition to IVDR fall under the co-developed or follow-on scenarios, depending on how they were initially developed.

Q: Is it possible to proceed with a single CDx consultation procedure for multiple authorized medicinal products and indications?

A: Yes, if a device’s intended purpose includes several authorized medicinal products and indications, it’s recommended to proceed with one single CDx consultation procedure. All concerned medicinal products should be listed in the intention to submit a letter by the Notified Body and in the application form.

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.

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MDR Transition Period: Updated Q&A Document, Changes & Clarifications

July 20, 2023

The recent amendment of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) through Regulation (EU) 2023/607 has introduced crucial changes to safeguard public health, prioritize patient safety, and prevent disruptions in healthcare services. The Q&A document regarding the extension of the MDR transition period and removal of the “sell-off” periods has been updated (July 2023) in response.

Key Changes to the Q&A Document on the MDR Transition Period

MDx CRO had previously published a comprehensive summary of the European Commission’s Q&A document.

The following questions in the Q&A document have undergone significant changes:

Q&A no 1: The Commission will provide flowcharts to assist manufacturers and other relevant parties in determining whether a device falls under the extended transitional period specified in Article 120 MDR.
Q&A no 2: Clarifies that a letter from a notified body regarding the certificate’s expiry or a controlled phase-out of production, mutually agreed upon by the notified body and the manufacturer before 20 March 2023, is not considered a certificate withdrawal.
Q&A no 7: Manufacturers need to provide a self-declaration confirming their compliance with the extension conditions and stating the end date of the transition period. They can include a “confirmation letter” from the notified body, which identifies the devices and certificates covered. Templates for the self-declaration and notified body’s confirmation letter are available at this link. Furthermore, an updated factsheet for competent authorities in non-EU/EEA countries explains the functioning of the extended transition period.
Q&A no 8: Clarifies that that when submitting information, notified bodies (as per Article 36(2) MDR) must have the capability to include the relevant (digital) document(s) in their own records. Simply having ‘read-only’ access to the manufacturer’s electronic data platform is not considered sufficient.
Q&A no 17: Manufacturers must inform the notified body about devices that require surveillance, especially if surveillance activities were discontinued due to certificate expiration before 20 March 2023. This information allows the notified body to conduct proper surveillance and make necessary arrangements with the manufacturer.

New Additions to the Q&A Document

The following questions have been newly introduced in the MDR Transition Period Q&A document:

Q&A no 6.1: If a competent authority grants a national derogation under Article 59 MDR or requires a manufacturer to follow the applicable conformity assessment procedure as per Article 97 MDR after 20 March 2023, the extended transitional period specified in Article 120(3a) MDR does not apply.
Q&A no 6.2: If the removal of the CE marking is a condition or consequence of the derogation granted by the competent national authority according to Article 59 of the MDR, the device may still be placed on the market with a CE marking, provided that all other conditions are met.
Q&A no 9.1: If a manufacturer withdraws the conformity assessment application or terminates the written agreement with the notified body after the deadlines, the extended transitional period ends. However, if the manufacturer switches to another notified body and fulfills all conditions, the transitional period continues. Updated documentation is necessary after the change, except when changing notified bodies due to non-compliance.
Q&A no 9.2: The manufacturer’s organization may undergo administrative changes, such as changes in name, address, or legal form, which generally do not impact the transitional period during the extended transition period. However, the transfer of devices from a manufacturer certified under MDD/AIMDD to another manufacturer intending to market them under MDR is not covered by the transitional period, unless both manufacturers are part of the same larger organization.
Q&A no 11.1: Legacy devices are not required to comply with the Unique Device Identification (UDI) requirements of the MDR during the extended transitional period. Even after May 26, 2024, when the manufacturer of the legacy device must have an MDR-compliant Quality Management System (QMS), UDI requirements will only apply if UDI assignment is necessary for those devices according to Article 10(9), point (h), of the MDR.

MDR Transition with MDx CRO

In conclusion, these recent changes and additions to the medical device regulations are significant milestones that harmonize industry standards and ensure a smooth transition for legacy devices, prioritizing safety and public health. The Q&A document serves as an essential tool for manufacturers, notified bodies, and competent authorities navigating the evolving regulatory landscape within the European Union.

Take advantage of MDx CRO’s expertise to ensure MDR compliance and meet transitional period requirements. Partnering with MDx CRO empowers manufacturers to meet safety standards, unlock opportunities in the European healthcare market, and contribute to healthcare advancements.

Contact us today!

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