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TÜV SÜD
MEDDEV Rev. 4
Extension of implementation timeline
 
 August 2017
 
Dear ladies or gentleman,

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), TÜV SÜD 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

If you have any further questions, please do not hesitate to contact our global clinical focus team: clinical.focus.team@tuev-sued.de.

Best regards,



Dr. Bassil Akra
 
 
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