A Practical Guide to EU MDR Compliance
“MDCG 2020-6 provides essential clarity for legacy devices, helping manufacturers bridge the gap between historical data and today’s MDR standards.”
by Dr Nadhim Bayatti
Senior Analyst, SciMed Consultancy Ltd
EXECUTIVE SUMMARY
Updating Clinical Evaluation Reports (CERs) for legacy devices under MDR is a critical requirement, and manufacturers must take a proactive approach to ensure compliance and protect EU market access.
Regulators are applying greater scrutiny to ensure there is sufficient clinical evidence, especially for high-risk and implantable devices.
Well-Established Technologies (WET) and standard-of-care devices may require less evidence, and in some cases clinical data may not be appropriate, but justification must align with the relevant MDCG guidance.
Strong Post-Market Surveillance (PMS) data systems, targeted Post-Market Clinical Follow-up (PMCF) studies, and structured Systematic Literature Review and Appraisal are essential tools for closing clinical evidence gaps.
A well-documented Clinical Evaluation Strategy, supported by a robust Clinical Evaluation Document Suite, is the most effective way to demonstrate compliance and maintain uninterrupted CE marking.
YOUR CHECKLIST FOR COMPLIANCE
Confirm legacy device status and eligibility under MDR.
Determine evidence needs using MDCG 2020-6 guidance.
Close any clinical evidence gaps with PMS, PMCF, and literature review.
Maintain a complete Clinical Evaluation Documentation Suite.
Justify all decisions with traceable references to GSPRs and MDR guidance.
INTRODUCTION
Many manufacturers are now facing one of the most difficult aspects of MDR transition: updating Clinical Evaluation Reports (CERs) for legacy devices. While these devices benefit from transitional arrangements, regulators expect stricter evidence standards and more robust justifications than under the MDD or AIMDD.
At SciMed, we support clients struggling with questions such as: What qualifies as sufficient clinical evidence for a legacy device? How can Well-Established Technologies (WET) or Article 61(10) MDR be leveraged effectively? And most importantly, what steps in Clinical Evidence Gap Analysis and Remediation Planning must be taken now to avoid compliance gaps that could jeopardize CE marking and EU market access?
What are Legacy Devices under MDR?
These are devices that had a valid MDD or AIMDD CE certificate on 26 May 2021. The certificate must not have expired before 20 March 2023, or if it has expired, it must not have been withdrawn by the Notified Body. Additionally, these devices must have a signed written agreement in place, or they must have been granted an Article 59(1) derogation or Article 97(1) authorization by an EU Competent Authority.
A device loses legacy status if it undergoes a significant change to design or intended purpose. Not all devices qualify as legacy; Class I devices requiring no Notified Body involvement under the EU MDR should already follow the new regulation.
What are Well-Established Technologies (WET) and Standard of Care Devices?
WETs are a defined group of devices specifically called out within the EU MDR. Article 52 describes these as certain Class IIb implantables. A specific list of devices features in Article 61(6), however, the term “WET” is not restricted to these devices alone. Article 61(8) states that the term can also apply to devices similar to those devices listed and may be added to in future.
Common features of such similar devices include:
Simple, stable designs with little evolution,
Well-known safety profiles and no significant past safety issues,
Well-established clinical performance and role as standard of care,
Long market history.
For such devices, the level of evidence required in a Clinical Evaluation Report (CER) may be lower if the above conditions are met.
WHAT ARE THE BIGGEST CHALLENGES IN PRODUCING AN MDR-COMPLIANT CLINICAL EVALUATION FOR LEGACY DEVICES?
A recent study (Kearney & McDermott, 2023) highlighted the challenges manufacturers face when developing an MDR-compliant CER for their legacy device. By far, the biggest problem manufacturers identify for developing an EU MDR-compliant CER is determining the "amount of data needed to generate sufficient clinical evidence." Specifically for legacy devices transitioning to MDR, addressing gaps in clinical data is essential.
Manufacturers can remediate this through:
Leveraging Post-Market Surveillance (PMS) data
Conducting Systematic Literature Review and Appraisal
Implementing Post-Market Clinical Follow-up (PMCF) studies
Addressing these evidence gaps requires resources and structured processes, including Clinical Evaluation Documentation preparation and clear Strategy Development.
IS YOUR LEGACY DEVICE DEFENSIBLE UNDER MDR?
For many legacy devices, the issue is not whether data exists, it is whether the clinical evidence strategy meets current MDR expectations.
Our Clinical Evaluation Audit Checklist is designed to help you assess that risk before it becomes a notified body finding.
It helps you identify:
Gaps in clinical evidence relative to MDCG 2020-6 expectations
Weak justification of Well-Established Technology (WET) status
Misalignment between PMS, PMCF, and clinical evaluation
Insufficient or poorly structured literature appraisal
Where your CER may not hold up under audit
WHAT CONSTITUTES SUFFICIENT CLINICAL EVIDENCE?
MDCG 2020-6 is the guidance created specifically to examine sufficiency of data for legacy devices.
Appendix III of MDCG 2020-6 provides a suggested hierarchy of clinical evidence for legacy devices. For high-risk devices, such as non-WET Class III/implantable devices, a high degree of clinical evidence is required (clinical data at a minimum of Rank 4 in the hierarchy).
However, for legacy devices that are WET/standard of care, the clinical evidence requirement is lower, at Rank 6 of the hierarchy: "Evaluation of state of the art, including evaluation of clinical data from similar devices…" Thus, data on the generic device group as well as similar devices can be supportive of conformity to the relevant GSPRs if clinical data is missing on the device under evaluation.
WHEN CLINICAL DATA MAY NOT BE APPROPRIATE – ARTICLE 61(10)
Article 61(10) of the MDR¹ describes how conformity with the GSPRs for some non-Class III or implantable devices may be possible when clinical data is deemed inappropriate. These tend to be devices that do not have 'direct' interaction with the human body, although interaction is not excluded. However, if a manufacturer of a medical device is making clinical claims from its clinical performance that lead to a clinical benefit, then clinical data is required, and Article 61(10) no longer applies. Consideration must be given to duration, design, risks, novelty, and their role in performance of the overall medical procedure. Low-risk devices without direct interaction, with no direct patient benefit and claims, are ideal candidates for using Article 61(10) to prove conformity to the GSPRs of the MDR.
Even in these cases, manufacturers must still hold a complete Clinical Evaluation Documentation Suite with, at a minimum:
A documented Clinical Evaluation Plan
A Systematic Literature Review and Appraisal of the State of the Art in Clinical Evaluation
A robust Clinical Evaluation Report
Supporting rationale tied to Notified Body expectations.
SUMMARY
When updating a Clinical Evaluation for Legacy Medical Devices, manufacturers must carefully assess whether current evidence is sufficient under MDCG 2020-6 guidance. For Well-Established Technologies (WET) or standard-of-care devices, limited new data may be acceptable. For low-risk devices under Article 61(10) MDR, clinical data may not be required, but a documented Clinical Evaluation Report (CER) supported by literature and risk assessment is still mandatory.
Ultimately, a structured approach is essential for achieving MDR-compliant Clinical Evaluation and safeguarding EU market access.
LEGACY DEVICE COMPLIANCE UNDER MDR IS NOT A ONE-OFF EXERCISE
MedTech Horizon provides monthly guidance on clinical evaluation strategy, MDCG interpretation, and how manufacturers are addressing legacy device challenges in practice.
USEFUL REFERENCES
The EU MDR (Reg. (EU) 2017/745) can be found here.
The MDCG’s guidance on Clinical Evidence for Legacy Devices can be found here.
The MDCG’s guidance on MDR Requirements for Legacy Devices can be found here.
Kearney & McDermott’s 2023 Study “The Challenges for Manufacturers of the Increased Clinical Evaluation in the European Medical Device Regulations: A Quantitative Study” can be found here.
If you are actively updating legacy device documentation or preparing for notified body review, you can speak with our team for a focused discussion.
