Is Your Clinical Evaluation MDR-Ready?
A Strategic Guide to Article 61 & Annex XIV Compliance
“The question in today’s regulatory world isn’t whether your device works; it’s whether you can prove it, transparently and defensibly in line with the expectations of Article 61 and Annex XIV.”
by Dr Nicola Edwards
Senior Analyst, SciMed Consultancy Ltd
EXECUTIVE SUMMARY
As EU MDR compliance enforcement tightens in 2025, manufacturers must be prepared to defend the quality, relevance, and sufficiency of their clinical evidence.
EU MDR Article 61 and Annex XIV now require manufacturers to justify clinical evidence levels and demonstrate General Safety and Performance Requirements (GSPRs) compliance.
A robust Clinical Evaluation Plan (CEP) must define intended use, clinical benefits, and methods for benefit-risk assessment.
A compliant Clinical Evaluation Report (CER) should address clinical evidence gaps, alternative therapies, and literature relevance.
Equivalence claims must be backed by thorough comparison of clinical, technical, and biological characteristics.
This article highlights key considerations to ensure your clinical evaluation is MDR-ready and audit-compliant.
YOUR CHECKLIST FOR COMPLIANCE
Have you identified the GSPRs relevant to your device?
Have you developed a compliant clinical evaluation plan?
Have you generated a compliant clinical evaluation report?
Can you demonstrate that your device achieves its intended purpose and is safe to use, taking into account the benefit:risk ratio across all intended users?
INTRODUCTION
Under EU Regulation 2017/745, manufacturers must provide rigorous, evidence-based Clinical Evaluation Reports (CERs) that clearly demonstrate GSPRs compliance. From Article 61 & Annex XIV, the MDR outlines regulatory expectations for new device submissions and legacy products. This blog offers a strategic guide for aligning your Clinical Evaluation Plan (CEP) and CER with current MDR standards - avoiding common pitfalls that delay CE marking or trigger non-conformities.
INDUSTRY CONTEXT & BACKGROUND
The European Union’s MDR 2017/745 replaced the Medical Device Directive (MDD), introducing stricter clinical evidence requirements, eliminating grandfathering provisions for legacy devices, and making clinical evaluation central to demonstrating regulatory compliance.
Under the MDD, equivalence and literature review alone were often sufficient. Under the MDR, manufacturers must provide a structured Clinical Evaluation Plan (CEP) and a robust Clinical Evaluation Report (CER) that directly map to GSPRs (Annex I) and satisfy Article 61 and Annex XIV Part A. This regulatory shift reflects the EU’s commitment to patient safety, data transparency, and continuous post-market vigilance.
THE STATUS OF THE MDR IN 2025
In May 2017, the EU Parliament published Regulation 2017/745, known as the EU Medical Device Regulations. These regulations were intended to replace the Medical Device Directive (MDD), which had been in effect since 1993. The MDR introduced new medical device classifications and definitions, improved safety requirements, and assessed performance over the device lifetime in a consistent, regulated manner.
The EU MDR applies to all manufacturers selling medical devices on the European market and must be implemented for all relevant devices placed on the market since 26th May 2024.
HOW CAN I ENSURE MY CLINICAL EVALUATION IS MDR COMPLIANT?
To place their medical device on the EU market, a manufacturer must demonstrate that the intended purpose and claims made in relation to safety and performance of their medical device are achieved, as per the General Safety and Performance Requirements (GSPRs) of the MDR. This post will explain how to address these GSPRs and produce a clinical evaluation that is MDR compliant. To do so, we will examine three key sections of the regulatory text – Article 61, Annex I, and Annex XIV Part A. Some small amendments have been made to the MDR text since 2017, therefore this information has been taken from the most recent text (dated January 2025).
MDR ARTICLE 61: THE ROLE OF A CLINICAL EVALUATION
The MDR text emphasises that the clinical evaluation must be based on clinical data, providing sufficient clinical evidence to satisfy the GSPRs and benefit:risk assessment. It is the responsibility of the manufacturer to specify and justify the level of clinical evidence necessary. This justification is based on the device characteristics and intended use. The clinical evaluation must be updated throughout the device lifetime, in accordance with PMCF and PMS plans, and presented as a clinical evaluation report (CER).
The process of clinical evaluation must be a defined and methodologically sound procedure. This involves three parts:
A critical evaluation of scientific literature relevant to the safety, performance, design, and intended purpose of the device. The data must demonstrate compliance with the GSPRs, and if they do not describe the particular device under evaluation, they must feature a device that is suitably equivalent.
A consideration of currently available alternative treatment options.
A critical evaluation of all available clinical investigations, including their methodologies[1].
[1]There are certain caveats that allow clinical investigations to be skipped, provided there are enough data to satisfy the GSPRs. These caveats are found in paragraphs 4-8 of Article 61.
MDR ANNEX I: HOW TO SATISFY THE GENERAL GSPR REQUIREMENTS?
Chapter 1, Annex 1 of the MDR lists nine paragraphs as general safety and performance requirements. The first and last provide a clear overview of the aim that all manufacturers should strive for: that the device achieves its intended purpose, that it is designed to do so under normal conditions of use, and that it is safe to do so. Medical devices should not compromise patient, user, or bystander safety, and any risks of use should be considered acceptable when weighed against potential patient benefit. The state-of-the-art should be considered when making these conclusions.
Further GSPRs are then described, and we outline them below:
2. Risks must be reduced as far as possible without adversely affecting the benefit-risk ratio.
3. Manufacturers must establish and maintain a risk management system that is updated throughout the device lifetime[1].
Risk control measures must conform to safety principles, taking into account the state-of-the-art, to reduce risk to an acceptable level. This involves reducing risks as far as possible, taking adequate protection measures, and providing safety information or training to users. Residual risk must be communicated to users.
In reducing risks relating to use error, the manufacturer must reduce as far as possible any risks related to ergonomic device features and the intended use environment and give consideration both to the understanding/experience and the medical/physical condition of the intended user.
The characteristics and performance of the device must not be affected by stresses of normal use and maintenance throughout its lifetime such that health or safety of the patient/user is compromised e.g. avoidance of wear and tear.
The device must be packaged such that its characteristics and performance shall not be affected by conditions of transport or storage e.g. fluctuations in temperature.
All known and foreseeable risks, and any undesirable side effects, shall be minimised and be acceptable when weighed against the evaluated clinical benefit.
Although these GSPRs do focus on risk and safety, clinical data is key to establishing a benefit:risk argument and therefore should be prioritised alongside the risk management documentation.
[1]More information on the content of the risk management system is found in paragraph 3 of Chapter 1.
A top-down summary of the GSPRs as listed in the chapters of Annex I is shown below.
MDR ANNEX XIV PART A: WHAT GOES INTO A CLINICAL EVALUATION?
A compliant clinical evaluation relies on two key outputs: a clinical evaluation plan and a clinical evaluation report. It should also take into account both favourable and unfavourable data.
The Clinical Evaluation Plan
A compliant clinical evaluation plan must include the following:
An identification of the relevant GSPRs to be met
The intended purpose of the device
The intended target groups, with clear indications and contra-indications
A detailed description of intended clinical benefit to patients and specified clinical outcome parameters
The methods to be used for qualitative and quantitative assessment of clinical safety, with clear reference to the determination of residual risks and side effects
A list and specification of parameters to be used to determine the acceptability of the benefit:risk ratio of the device. These parameters should be based on the state-of-the-art and cover all indications and intended purposes.
Acknowledgement of how benefit:risk issues relating to specific components e.g. pharmaceutical, or non-human tissues, are to be addressed
A clinical development plan describing progression from exploratory to confirmatory investigations, and post market clinical follow-up documentation
The Clinical Evaluation Report
A compliant clinical evaluation report must include the following:
A systematic literature review of clinical data relevant to the device and its intended purpose, identifying any gaps in clinical evidence
An appraisal of all relevant clinical data in terms of their suitability for establishing the safety and performance of the device
The generation of new data to fill any evidence gaps, via clinical investigations designed according to the clinical development plan
An analysis of all relevant clinical data to reach conclusions about safety and performance of the device, and its clinical benefits.
HOW LONG SHOULD A CER BE?
The depth and extent of a CER should reflect the nature, classification, intended purpose, known risks, and claims of the device. For example, the CER of a well-established technology with limited risk is likely to be shorter than that of a new technology with numerous intended purposes and clinical claims.
CAN I USE CLINICAL DATA FROM AN EQUIVALENT DEVICE TO SATISFY THE GSPRS?
Clinical data from another device can be used provided the equivalent device is sufficiently similar such that no clinically significant difference in performance and safety is expected. This must be justified with sound scientific evidence, and technical, biological, and clinical characteristics must be matched.
SUMMARY
As EU MDR enforcement intensifies, Clinical Evaluation Reports must stand up to heightened regulatory scrutiny. This strategic guide outlines how to align with Article 61 and Annex XIV, including best practices for defining intended use, demonstrating GSPR compliance, justifying clinical evidence levels, and supporting equivalence claims. Designed for regulatory and clinical affairs leaders, this post helps identify potential weaknesses in your clinical evaluation strategy development, clinical evidence gap analysis, and prepares you proactively for regulatory audits.
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