What is MDR Clinical Evaluation?
Medical Device Regulation (MDR) 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, including Class I devices that don’t require Notified Body review.
The clinical evaluation is part of manufacturer quality management and should be aligned with and reflected in other aspects of the Technical Documentation, such as:
• The interface of the clinical evaluation with the risk management process
• the 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 report; and
• Instructions for use (IFU)
Notified bodies presented their expectations regarding the company clinical evaluation process and documentation in 2020-07 MDCG_clinical_evaluation_template. The Authorized Representatives (ARs) follow the same guidelines for the clinical evaluation documentation review of Class I medical devices, which must comply with MDR from 26 May 2021.
Clinical Evaluation Procedure
The manufacturer needs to have a procedure to keep the clinical evaluation plan up to date, considering state of art (MDR, Annex IX, Chapter I (2.1).
Clinical evaluation should be performed by 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).
See MEDDEV 2.7/1 revision 4 (2016) Sections 7 and MDR, Annex XIV, Part A (1a) for the CEP content.
In CER, the company needs to provide a statement about the data used in the clinical assessment. The data relevant to the clinical evaluation may be:
• generated and held by the manufacturer or
• available from scientific literature, or
Writing Compliant CER
CER should be consistent, self-sufficient, and searchable. All product-related info (and others) in CER should be the same throughout the document and reflect what is written in other parts of Technical Documentation, such as labeling, IFU, and promotional materials.
CER should be self-sufficient and contain at least summaries of all referenced documents. It would help if you wrote in a way it would be understandable for the reviewer. CER should be in searchable text PDF format with bookmarks. The contents of the clinical evaluation report shall be cross-referenced with the relevant documents that support them. 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, are specifically relevant under the MDR. Ask yourself whether all the risks that could significantly impact the benefit-risk analysis have been identified in the clinical evaluation. Is there an alignment between risk management and clinical assessment? Provide a complete list of retrieved articles and rationale for those excluded.
Provide a statement and rationale for whether further clinical studies or other measures are necessary to generate missing data and eliminate compliance issues. To determine PMCF needs, consider residual risks and any uncertainties or unanswered questions.
Please note that a suitably qualified individual or a team should conduct the MDR clinical evaluation. In addition, the manufacturer should be able to justify the choice of the evaluators through reference to their qualifications and documented experience and present a declaration of interest for each evaluator.
Clinical Evaluation Literature Search
A literature search should be based on a search protocol that documents the search planning before execution. See literature search methods and strategy review in MEDDEV 2.7/1 revision 4, section A5 and MDCG 2020-13, Section D. The literature data should be retrieved from at least two databases (e.g., you can use PubMed & Cochrane Library). The search should clearly distinguish between two types of data: the device under evaluation (or its equivalent device) and the State of Art. 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. Perform appraisal of identified data based on the appraisal plan that describes the procedure and the criteria for the assessment. The appraisal could be qualitative or quantitative; qualitative data may suffice for the well-established and lower-risk devices. For the possible appraisal method, refer to Appendix D of the GHTF SG5/N2R8:2007 on Clinical Evaluation. See our recent post on how to do a literature search here:
We can assist you with the following tasks:
• Build strategy to waive or reduce additional clinical investigations
• Write MDR Clinical Evaluation procedure
• Write or review MDR Clinical Evaluation Plan
• Write or review MDR Clinical Evaluation Report
• Analyze and demonstrate equivalence to the comparator device
• Review or update a Summary of Safety and Clinical Performance (SSCP)
• Review or update a Periodic Safety Update Report (PSUR)
If you plan to write your first MDR 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.
Don’t hesitate to contact me directly if you need any assistance with MDR clinical evaluation issues or any other MDR tasks: email@example.com