NB Defers Clinical Evaluation

In June 2016, the EU published MEDDEV 2.7/1 Rev. 4 Clinical Evaluation: A Guide For Manufacturers And Notified Bodies Under Directives 93/42/EEC and 90/385/EEC. This new version, replacing Rev. 3, includes significant changes. The revision to Rev. 4 does not have an effective data, which has caused significant confusion. Some Notified Bodies expected immediate implementation of the guidance in the manufacturer’s technical file or design dossier. Others expected the manufacturer to develop a transition plan to meet the new requirements in Rev. 4.

TÜV SÜD extended its implementation timeline to allow manufacturers more time to ensure compliance. On May 5, 2017 the EU published the Medical Device Regulation with a transition period to May 25, 2020. During this time, TÜV SÜD intends to accept clinical evaluation to Rev. 3 or Rev. 4. From May 26, 2020, clinical evaluations must implement Rev. 4.

It is not clear if other Notified Bodies will follow this approach.