1. Read & understand Medical Device Regulation (MDR) – This is the most critical advice we can give. You should read MDR to know what clinical evaluation is and what is required from you. There are no shortcuts on this one.
2. What is Clinical Evaluation? – Clinical evaluation is an ongoing procedure to collect, appraise and analyze clinical data on a medical device (or its equivalent) to conclude whether there is sufficient clinical evidence for compliance with relevant General Safety and Performance Requirements (GSPR). Clinical evaluation is required for all medical devices (MDR, Article 61 (1)).
3. Legacy devices – For sufficient clinical evidence for legacy devices, see MDCG 2020-6 guidance.
4. Clinical evaluation is part of manufacturer quality management – It should be aligned with and reflected in other aspects of the Technical Documentation (TD), such as:
- the interface of the clinical evaluation with the risk management process and its appraisal and analysis of the preclinical and clinical evaluation and their relevance for the demonstration of conformity with the relevant requirements in MDR, Annex I;
- Post-market surveillance (PMS) including any corrective and preventive actions involving the device;
- Post-market clinical follow-up (PMCF) plan and, where appropriate the PMCF report;
- Instructions for use
5. Know what Notified Body (NB) expects from you – The NB expectations regarding the company clinical evaluation process and documentation are clearly presented in MDCG 2020-13 Clinical evaluation assessment report template (July 2020) guidance.
6. Clinical Evaluation procedure – You need a procedure to keep the clinical evaluation plan up to date (MDR, Annex IX, Chapter I (2.1).
7. Clinical Evaluation Plan & Report – Clinical Evaluation should be performed based on the company Clinical Evaluation Plan (CEP). See MDR Article 61 and Part A of Annex XIV). The clinical evaluation results and the clinical evidence on which it is based shall be documented in a Clinical Evaluation Report (CER).
8. CEP content – For CEP content, see MEDDEV 2.7/1 rev.4, Sections 7 and MDR, Annex XIV, Part A (1a).
More about CER
9. Type of clinical evaluation – You need to provide a statement about the data used in the clinical evaluation. The data relevant to the clinical evaluation may be either:
- generated and held by the manufacturer
- available from scientific literature, or
10. Be consistent – All product-related info in CER should be the same throughout the document and reflect what is written in other parts of TD, such as labeling, IFU, and promotional materials.
11. CER should be self-sufficient & searchable – CER should contain at least summaries of all referenced documents. Provide CER in searchable text PDF format with bookmarks. The contents of the clinical evaluation report shall be cross-referenced to the relevant documents that support them.
12. Device classification – Provide device classification in CER in accordance with MDR Annex VIII, Chapter III, Classification Rules.
13. Regarding the use of MDCG guidance – Although MDCG documents are not legally binding, there are considered as a State of Art (SOA) interpretation of MDR requirements. Therefore, you should take them into consideration.
14. Regarding the use of MEDDEV 2.7/1 Rev. 4 – Yes, your CER should comply with this MEDDEV guidance in addition to MDR requirements. Review Appendix I in MDCG 2020-6 (Sufficient clinical evidence for legacy devices, April 2020) for the sections of MEDDEV 2.7/1 rev. 4, which are specifically relevant under the MDR.
15. Updated standards – Follow the most updated standard (even if it is not harmonized under MDR); only a few are harmonized under MDR by now.
16. Justify the used standard – Provide the justification if you partially followed the updated standard or followed non-updated standard or guidance to demonstrate compliance with GSPR.
17. Know the hierarchy of standards – Follow the standards in the following descending order of significance: Common specifications, Harmonised standards (under MDR), Standards and MDCG Documents.
18. Multiple equivalence – If you claim equivalence to more than one device (why should you?), each equivalent device must meet all three equivalence criteria (clinical, technical, biological). We advise you to select only one device. Review Clinical Evaluation – Equivalence (April 2020) guidance.
19. Update the State of Art (SOA) – The current knowledge & SOA should be based upon updated literature search.
20. Benefit/Risk ratio – Make a list and specification of parameters used to determine, based on the SOA, the acceptability of the benefit/risk ratio for the intended purpose(s) or indications of the device.
21. The literature search should be based on protocol – Literature search should be based on a search protocol that documents the search planning before execution. For the literature search methods and strategy review MEDDEV 2.7/1 revision 4, section A5 and MDCG 2020-13, Section D.
22. Use at least two literature databases – The literature data should be retrieved from at least two databases. For, e.g., you can use PubMed & Cochrane Library database.
23. Distinguish two literature search data – Literature search should clearly distinguish between two types of data: the device under evaluation and the SOA.
24. Use of textbooks & conference materials – For SOA only, you can use this source of data to indirectly identify referenced literature.
25. About literature search info – The literature search should be documented in sufficient detail so that the methods can be appraised critically, the results verified, and the search reproduced if required.
26. Vigilance data – Search at least two competent authority databases such as MAUDE (FDA), TGA, MHRA, etc. See MEDDEV 2.7/1 revision 4, section 9.3.1 (c).
27. Appraisal – Perform appraisal of identified data based on the appraisal plan that describes the procedure and the criteria for the appraisal. The appraisal could be qualitative and/or quantitative; qualitative data may suffice for the well-established and lower-risk devices. For the possible appraisal method, you can refer to Appendix D of the GHTF SG5/N2R8:2007 on Clinical Evaluation.
28. Benefit/Risk Analysis – Ask yourself whether all the risks that could significantly impact the benefit-risk analysis have been identified in the clinical evaluation? Is there alignment between risk management and clinical evaluation?
29. Articles – Provide a complete list of retrieved articles and rationale for those which were excluded.
30. Position regarding additional clinical investigation – Provide a statement whether further clinical studies are necessary to generate missing data and eliminate compliance issues.
31. Regarding the evaluators – clinical evaluation should be conducted by a suitably qualified individual or a team.
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If you plan to write your first Clinical Evaluation Report (CER) and don’t know how to start – we advise you to use our CER template, which could be easily customized to your product – see here.
For the further information please contact:
Daniel Albahari M.Sc., RAC