Clinical Evaluation according to MEDDEV 2.7.1 Revision 4
The MEDDEV 2.7.1 Revision 4 has been published in June 2016 and is to its full extent and without any transition period applicable for the current european legislation MDD 93/42 EEC. It is expected that the Revision 4 will remain the standard for clinical evaluations also with the newly published Medical Device Regulation. This has relevant impact on you:
- Clinical Evaluation Reports (CERs) that need an update or are compiled for an initial product registration need to follow Revision 4 of MEDDEV 2.7.1
- The structure and interconnection of appraisal criteria as well as the analysis of the relevant literature is considerably more time-consuming for reports compiled according to Revision 4.
- CERs concerning risk products (class III and all implantable products) need to be updated annually, whereas CERs for all other products require an update every 2-5 years (following a clear justification of the update interval).
The compilation of a CER according to Revision 4 makes substantial demands on resources and competences:
- Enforced requirement: establishment and maintenance of a clinical evaluation plan
- Extensive knowledge and assessment of current state of the art of the relevant indications
- Augmented requirements for the use of equivalent devices
- Comprehensive and interconnected argumentation
- Competent authors and reviewer
With a systematic and well documented approach the transition to Revision 4 may be managed successfully and efficiently and the risk of criticism by your notified body reduced.
We are happy to support you in the planning, compilation or update of your clinial evaluations taking account of your individual priorities.
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