Clinical Evaluation: MEDDEV 2.7/1 Revision 4
A new guidance document for Clinical Evaluation (MEDDEV 2.7/1 Rev. 4) was released this summer providing new requirements and much-needed clarification in several areas. The new guidance offers clarity around writing a fully compliant and comprehensive clinical evaluation report (CER). As mentioned in an earlier post, “Effective Strategies for Compiling the Dreaded CER,” we notice many US-based medical device manufacturers are unaware of the European requirement for clinical evaluation and CER documentation – an oversight that could put your ability to market your product at risk.
A CER is a living document that includes clinical data, the appraisal and analysis stages of the evaluation, and conclusions about device safety and performance. This report is a required element of the technical documentation for any medical device that will be marketed or sold in Europe. Here, we review the stages of a clinical evaluation and highlight new requirements.
The revised version of the MEDDEV 2.7/1 adds a preliminary Stage 0 to highlight the importance of planning for the clinical evaluation. Before beginning a clinical evaluation, the scope should be defined based on the Essential Requirements that need to be addressed from a clinical perspective, and the nature and history of the medical device.
- Stage 0: Define Scope and Plan the Clinical Evaluation
- Stage 1: Identification of Pertinent Data
- Stage 2: Appraisal of Pertinent Data
- Stage 3: Analysis of Clinical Data, Draw Conclusions
- Stage 4: Finalize the CER
While most of Revision 4 provides direction on existing guidelines, there are a few new requirements to consider. Specific requirements around CER author and evaluator expertise are introduced in this revision to elicit review by more highly qualified individuals. Expertise is defined as having either five or 10 years of professional experience, depending on the person’s higher education degree(s) and whether or not a degree is considered a prerequisite for the task. Evaluators must make a declaration of interest and all qualifications must be documented and duly justified.
Another new requirement focuses on access to data. Relevant technical and clinical data from an equivalent device must be clearly assessed and documented as part of a clinical evaluation. Updates to Revision 4 indicate an expectation that notified bodies challenge the manufacturer’s access to data for similar devices with which equivalence is claimed.
Many device manufacturers are still transitioning to the new guidelines, but MEDDEV 2.7/1 Rev. 4 is expected to become the gold standard against which notified bodies will review clinical evaluation reports prepared by medical device manufacturers. As a result, some manufacturers may need to adjust their approach to clinical evaluation to ensure their medical devices reflect the rules and criteria defined in the new guidance.
If you need guidance on how to prepare or update a CER, contact us.