According to an established EU notified body, there will be an extended timeline for the MEDDEV 2.7/1 Rev. 4. On May 5, 2017, the new medical device regulation was published with a transition period of 3 years. Due to this fact and the fact that this regulation includes specific clinical requirements which are not consistent with the MEDDEV Guidance Document on clinical evaluation (MEDDEV 2.7/1 Rev. 4), the EU notified body decided to extend the implementation timeline for the reflection of the state-of-the-art methods of clinical evaluation. This decision was taken to allow medical device manufacturers to use their resources effectively when adopting the upcoming changes with the new regulation to their clinical evidence documentation. This extension is just possible if the requirements on clinical evaluation and active post-market surveillance of the applicable directive MDD and/or AIMDD are fulfilled. In particular, the following timelines are applicable from today: July 31, 2017 – May 25, 2020
Every submission can still follow the currently used methodology reflected in the MEDDEV 2.7/1 Rev. 3 or another comparable method
Every submission shall include a plan on how to reflect the current state-of-the-art method for clinical evaluation (i.e., MEDDEV 2.7/1 Rev. 4 or another comparable method)
Every technical documentation that is selected in this period shall either include a plan for the reflection of state-of-the-art methodology implementation as presented, for example, in the MEDDEV 2.7/1 Rev. 4, or be part of a general plan of the manufacturer
May 26, 2020
Every CER which is signed after May 26, 2020, shall be reflecting the current state-of-the-art method of clinical evaluation by either following the Rev. 4 of the MEDDEV or another comparable method