The current version of the guidance document MEDDEV 2.7/1 was published as Revision 4 on the website of the European Commission end of June 2016.

This document includes the methodology to conduct a clinical evaluation, defines the period of active updates, clarifies the identification and analysis of data, sets higher requirements on the evidence of product equivalence and specifies the activities of the Notified Body within the assessment procedure.

The guidance document was immediately published without a transition period. This has raised the question by manufacturers when to implement Revision 4. Hereby we would like to inform you about our expectations concerning the implementation of the new guidance document when performing clinical evaluations.

Initially it needs to be emphasized that MEDDEV. 2.7/1 is not legally binding but a guidance document of a particularly high level. The high relevance of this document is supported by the fact, that according to our knowledge there are no other standards or guidance documents for performing a clinical evaluation. As MEDDEV documents are not only applied by Notified Bodies but have also relevance for Competent Authorities and in product liability issues, they are a recognized state of the art.

Therefore manufacturers are strictly recommended to use the guidance. In case MEDDEV 2.7/1 Revision 4 is not fully applied, an alternative route, which achieves at least the same level, shall be used.

It is expected that manufacturers prepare a transition plan describing comprehensible measures with regard to checking and if required to adjust the clinical evaluation to MEDDEV 2.7/1 Rev. 4. These transition plans will be checked by mdc during the annual surveillance audits.

For all new applications (initial certification) it is expected, that the clinical evaluation documentation is in compliance to MEDDEV 2.7/1 Rev. 4. or an equal level.

It is generally expected that all new or essentially revised clinical evaluations comply with the new revision 4 or an equal level. Revision of all clinical evaluations shall be completed – depending on the product - within 1 to 5 years, as defined in section 6.2.3 3 (Updating the clinical evaluation) of the guidance.

This procedure will be executed subject to the definition of a common national or European regulation which certainly will be applied subsequently by mdc.