MDR Transitional regime clarified by MDCG

The Medical Devices Coordination Group (MDCG) has published a document concerning the validity of certificates issued in accordance to the Directive MDD [1] and AIMDD [2] after the new Medical Device Regulation (MDR) becomes applicable.

Article 120 (2) of the MDR states that certificates issued in accordance to MDD and AIMDD shall remain valid until the end of the period indicated on the certificate or 27 May 2024 whichever comes first. Those certificates shall become void at the latest on 27 May 2024.

The derogation from Art. 5 of the MDR is valid provided that from the date of application of this Regulation:

  1. The device continues to comply with either of the Directives and provided there are no significant changes in the design and intended purpose of the device.
  2. The requirements of the MDR relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in the Directives as of 26 May 2020.
  3. The Notified Body (NB) that issued the certificate must remain responsible for the necessary surveillance activities applicable to the device and it must have the possibility to take any necessary related measure – MDR, Art. 120(3)
  4. The manufacturer and the NB shall include contractual provisions allowing the appropriate performance of such surveillance activities.
  5. Authorities responsible for the NBs must have the right to monitor the NB’s activities, regardless if the NB has applied or not to be designated under the MDR and/or it has or not a valid designation under the MDD, AIMDD during the validity of the Certificates – MDR Art. 120(2) and Art.120(3)

The MDCG also clarified that, with respect to the MD and AIMD Directives, after 25 May 2021, NANDO will be only used for information purposes. It will clearly state that those NBs were designated under the Directives and cannot issue new certificates under MDR and are only allowed to carry out surveillance activities for valid certificates in the transitional period (and therefore comply with the conditions mentioned above).

Clàudia Miralles

Regulatory Affairs Department

November 15th, 2019

If you wish to know more about the new Medical Device Regulation, please do not hesitate to contact us through our website. With more than 30 years of regulatory experience, Obelis experts will gladly assist you. We guide companies around the world to comply to the European standards.

Get in touch

Share This

Copy Link to Clipboard