Following the release of revision 4 of MEDDEV 2.7/1 'Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC, published in June by the European Commission, it is important for manufacturers to ensure that the latest (detailed) requirements are included within your clinical evaluation report (CER) templates going forward.
The revised guidance covers general principles of conducting a clinical evaluation in much more detail and including new prescriptive appendices:
Stage 0: definition of scope of clinical evaluation (planning)
Stage 1: identification of pertinent data
Stage 2: appraisal of individual pertinent data sets
Stage 3: analysis of clinical data
Stage 4: finalisation of the clinical evaluation report
See more at http://ec.europa.eu/DocsRoom/documents/17522/attachments/1/translations/
The new guidance also includes the role of the notified body in the assessment of CER's. On that note, notified bodies will be looking more closely at how all the essential requirements are met including those with regard to usability / human factors (i.e. that the design adequately reduces the risk of use error as much as possible, due to the ergonomic features of the device and the environment in which it is used). Usability aspects are known to cause or contribute to a large proportion of incidents.
The concept of "equivalence" is an area that some manufacturers struggle with and this has now been more clearly defined. Equivalent devices should be almost identical to the device undergoing clinical evaluation. How often does the CER need to be actively updated? This frequency must be defined and justified by the manufacturer. For products that pose a "significant risk" to the user / patient and are not well established this needs to be performed at least annually and in other cases with a frequency of 2 to 5 years.
Kind regards,
Karen
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Karen Real
Director
Real Regulatory Ltd
London
United Kingdom
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