Article 61 requires Manufacturers to plan, conduct and document a Clinical Evaluation as a part of conforming with the general safety and performance requirements set out in Annex I.
The general requirements of the clinical evaluation process are set out in paragraph 3 of Article 61. The clinical evaluation process must be ”a defined and methodologically sound procedure” and must include (a) “a critical evaluation of the relevant scientific literature…”, (b) “a critical evaluation of the results of all available clinical investigations…”, and (c) “consideration of currently available alternative treatment options…”. But these are quite general statements and not sufficient on their own for defining a robust process. Further detail on the required clinical evaluation process is provided in Annex XIV.
According to paragraph 1 of Part A of Annex XIV there must be a Clinical Evaluation Plan, implying (a) a planning stage (Stage 0), (b) a stage of identifying relevant clinical data (Stage 1), (c) a stage of appraising the data (Stage 2), (d) depending on the outcome of the appraisal, potentially the generation of new data through clinical investigations, (e) a stage of analysing the data (Stage 3). Finally, according to paragraph 4, the process must produce a Clinical Evaluation Report, implying a reporting stage (Stage 4).
Those readers who are familiar with the MEDDEV guidance document 2.7/1 rev. 4 “Clinical evaluation: Guide for manufacturers and notified bodies” will probably recognise the process described in Part A of Annex XIV, as being essentially the same as the process described in the MEDDEV 2.71 rev. 4. That’s clearly not a coincidence. The authors of the EU MDR evidently had the 2016 MEDDEV in mind when writing Part A of Annex XIV. That’s good news: It means that any Manufacturer with a clinical evaluation process based on MEDDEV 2.7/1 rev 4, is already well advanced in complying with the clinical evaluation requirements of the Regulation. It also means that any new Manufacturers looking to implement a clinical evaluation process for the first time, can base their process on MEDDEV 2.7/1 rev. 4 and they wont go far wrong, even if the MEDDEV was written for the Directive. Note: At the time of writing this article, no EU MDR specific clinical evaluation guidance had been published.
In general MEDDEV 2.7/1 rev 4. contains more detail and clarity than the requirements in Annex XIV, but there are three points where the Regulation goes beyond the MEDDEV. The first is in relation to the Clinical Evaluation Plan, the content of which is specified in Paragraph 1 (a) of Annex XIV. The second is in relation to the PMCF Plan, the requirements for which are specified in paragraph 6 of Annex XIV Part B. The third is the requirement, according to paragraph 7, to produce, during the post market phase, a PMCF Evaluation Report. While the precise content of the PMCF Evaluation Report is not specified, paragraph 8 makes clear that the PMCF Evaluation Report can be a potential source of information for; (a) updating the Clinical Evaluation Report, (b) updating the Risk Management Report, (c) identifying corrective or preventive actions. Implying that the conclusions of the PMCF Evaluation Report must at least consider these three topics.