The latest version of the clinical evaluation of medical devices guideline, MEDDEV 2.7/1 Rev.4 was published by the European Commission in June 2016.

A new medical device regulation published on 5, May 2017 required some specific clinical evaluations that are not consistent with the MEDDEV 2.7/1 Rev. 4.

The EU notified body decided to extend the timeline for this clinical evaluation to give the manufacturers more time to prepare their clinical evidence documentation according to the changes in the new regulation, reflecting the state-of-the-art method for the evaluation.

If the requirements on clinical evaluation and active post-market surveillance of the applicable directive MDD and/or AIMDD are fulfilled, the extension is applicable.

The following timelines are applicable from now:

July 31, 2017 – May 25, 2020

·         All submissions can still use the previous version MEDDEV 2.7/1 Rev. 3

·         A plan on how to reflect the state-of-the-art method for the evaluation should be included in all submissions (also in every technical documentation)

May 26, 2020

·         After May 26, 2020, all CER should include the current state-of-the-art method of clinical evaluation following the new MEDDEV 2.7/1 Rev. 4. or another comparable version method.