How to Write a Medical Device Clinical Evaluation Report Under MDR 2017/745
One of the most important documents that a medical device manufacturer has to produce under EU MDR 2017/745 is a Clinical Evaluation Report (CER). It provides proof that a device does what it is intended to do, is safe for patients and users and meets the General Safety and Performance Requirements (GSPRs) set out in Annex I of the MDR. Unlike the older MDD framework, the MDR framework demands a much higher depth, rigour and ongoing maintenance of clinical evidence.
This guide details the components of a well-structured CER and what manufacturers should consider at each stage.
Scope and Objectives
Each CER should have a well defined scope. This establishes the field of evaluation and helps to keep the document focused and audit-able. The scope should cover:
- An accurate description of the device and the intended purpose
- Target Patient Population and Use Indications
- The risk classification of the device according to the MDR 2017/745 (Rule 1–22, MDR Annex VIII)
- Contraindications, claims and clinical benefits to be claimed by manufacturer
By setting the objectives upfront, the CER will be meaningful and the clinical evidence collected will be directly relevant to support those claims.
Description of Device
The whole CER is based on a detailed description of the device. It shall describe the design, materials, mechanism of action, intended use and any variants or accessories within scope. Importantly, it should also determine what makes the device different from – or comparable to – existing products in the market;
Accuracy and completeness are critical here, since this section feeds directly into the equivalence assessments and state-of-the-art comparisons that appear later in this document.
Current state of the art
Under MDR 2017/745 and MDCG 2020-6, manufacturers are required to benchmark their device against the current “state of the art” – defined as the developed stage of current technical capability and what is generally accepted as good practice. This is not just a literature review but a systematic assessment of:
- Relevant clinical guidelines and standards (e.g. ISO, EN standards)
- Current clinical practice in the therapeutic area
- Devices akin to those available on the market now
- Any benchmark performance or safety limits set in the field
This section provides the standard by which the safety and performance of your device will be evaluated.
Clinical Evaluation Strategy (CES)
Prior to any data collection or evaluation, a Clinical Evaluation Plan (CEP) shall be developed. The CEP is a living document required under MDR Annex XIV Part A and describes:
- The device intended use and clinical indications
- Methodology for identification, evaluation and analysis of clinical data
- The criteria for equivalency (if applicable)
- What constitutes sufficient clinical evidence – criteria for acceptance
- The link between the CEP and the Post-Market Clinical Follow-Up (PMCF) plan
The CEP ensures a systematic, transparent and reproducible assessment which is scrutinised by Notified Bodies during conformity assessment.
Sources of Clinical Data
Strong CER is supported by multiple streams of clinical evidence. They generally include:
- Pre-market clinical investigations under MDR Article 62 or legacy studies
- Systematic searches of databases such as PubMed, EMBASE and Cochrane for published scientific literature Post-Market Clinical Follow-Up (PMCF) data, such as registries, surveys and real-world evidence studies
- Equivalent device data, where equivalence has been validly demonstrated according to MDCG 2020-5
All sources of data should be evaluated for relevance, quality and clinical significance. Using a structured appraisal tool (e.g. tools based on MEDDEV 2.7/1 rev. 4 methodology) ensures that only high quality, applicable data is used to support clinical conclusions.
Identification and Critical Evaluation of Clinical Data
The analytical core of the CER is the identification and critical appraisal of clinical data. This process includes:
- Systematic literature searches with defined search strings and inclusion/exclusion criteria
- Methodological quality, risk of bias and relevance to the device and its intended population were assessed for each study.
- Give the evidence a weight according to the level (for example RCT data versus case series versus registry data)
- Identifying any gaps in the clinical evidence and how these will be addressed – usually through PMCF activities
The CER must be transparent regarding data limitations. A Notified Body will be looking not only for positive data, but evidence that the manufacturer has been honest and critical in their assessment of the full body of evidence.
Analysis of Risk-Benefit
Manufacturers must demonstrate that the clinical benefits outweigh the residual risks of the device under the MDR. This analysis must be data driven, not assertion driven. It needs to deal with:
- Nature, frequency and severity of adverse events and complications identified in clinical data
- Anticipated clinical benefits (magnitude of effect and relevance to patients)
- How the design and instructions for use of the device mitigate residual risks
- ISO 14971 compliance (risk management) and how clinical risk-benefit feeds into the overall risk management file
This section will be updated as more safety or performance information is obtained from post-market surveillance.
- Postmarket Surveillance and Postmarket Clinical Followup
- Post-market surveillance (PMS) is not optional under MDR 2017/745 – it is a continuous, structured obligation. The CER shall set out:
PMS system in place on how adverse event data, user feedback and vigilance reports are collected and analysed
The PMCF plan, describing specific clinical activities to proactively collect ongoing evidence (e.g., patient registries, clinical studies, structured questionnaires)
How PMS findings feed back into the CER on a regular basis
A Periodic Safety Update Report (PSUR) needs to be compiled at defined intervals from the PMS data and update the CER for Class IIa and above. The PSUR is required annually for implantable and Class III devices.
Abstract
A compliant CER under MDR 2017/745 is far more than a summary of the literature. A CER is a structured evidence-based argument that your device is safe, performs as intended and that clinical benefits outweigh risks for the intended patient population. Every element from the Clinical Evaluation Plan to the incorporation of post-market surveillance must be methodical and traceable.
Given the level of scrutiny Notified Bodies apply, manufacturers are strongly encouraged to involve experienced clinical evaluation professionals early on, particularly for higher risk devices.
Need Help with Your Medical Device Clinical Evaluation Report Documentation?
Our team of regulatory affairs specialists has extensive experience in the preparation of CERs for Class I through Class III medical devices for EU and UK markets. Whether you are preparing for initial certification or re-certifying an existing CER post PSUR review, we can help.
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Citations
- MEDDEV 2.7/1 Revision 4 – Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC
- MDCG 2020-5 – Clinical Evaluation – Equivalence
- MDCG 2020-6 – Regulation (EU) 2017/745: Clinical Evidence Needed for Medical Devices Previously CE Marked under Directives 93/42/EEC or 90/385/EEC
- MDCG 2022-2 – Guidance on General Principles of Clinical Evidence for In Vitro Diagnostic Medical Devices
- Commission of the European Communities. Regulation (EU) 2017/745 – Medical Device Regulation (MDR), including Annex XIV and Annex I (GSPRs)
- ISO 14971:2019 – Application of Risk Management to Medical Devices
