The latest revision of MEDDEV 2.7.1 published last month is more or less a total re-write, and may up-end manufacturer’s clinical plans as well as studies underway to support CE Marking but not yet submitted in tech file or design dossier. In line with the ever-increasing scrutiny being placed on Notified Bodies, the revision will likely result in more and larger clinical investigations vs. the less onerous and popular clinical evaluation route which has been used by thousands of manufacturers for the past decade. Manufacturers may find many of the appealing aspects aspects of CER coming to an end: The criteria and documentation of device equivalency is increasing, CER reports need to be updated more often, and the evaluator’s CER qualifications rise to a higher bar and must be documented as such. The MEDDEV also creates more work for the Notified Bodies – a CEAR (Clinical Evaluation Assessment Report) will be required for all reviews – and as part of their assessment, the Notified Bodies may need to beef up their internal review processes and expertise with the Competent Authority. As such, this has the makings for increased revenue associated with Clinical Evaluation reviews during Notified Body product reviews.
For a complimentary copy of the guidance, click here. Is your product labeling in need of a global make-over? For more info about the MEDDEV and how The CRO Group may be of assistance in clinical evaluations and investigations supporting CE Marking, and how you may just
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