European Commission: MDR and IVDR Amendments Q&A

The European Commission has published a document which covers common questions being asked about the new MDR and IVDR transitional provision amendments.

It answers the following questions:

  1. Which devices can benefit from the extended transitional period?
  2. Can devices that have already been certified in accordance with the MDR benefit from extended transitional period?
  3. What about ‘legacy devices’ for which the manufacturer does not wish to apply under the MDR?
  4. Which classification rules apply to determine whether the extended transitional period ends on 31 December 2027 or on 31 December 2028?
  5. Does the extended transitional period also apply to custom-made devices?
  6. If a certificate has expired before 20 March 2023 and a competent authority has granted a derogation in accordance with Article 59 MDR or has applied Article 97 MDR, how long is the transitional period?
  7. How can the manufacturer demonstrate that its legacy device benefits from the extension of the transitional period?
  8. What are the necessary elements of a formal application lodged by the manufacturer?
  9. What are the necessary elements of a written agreement between the manufacturer and the notified body?
  10. What is the meaning of “device intended to substitute that device”?
  11. Which evidence does the manufacturer have to provide for having put in place a QMS in accordance with the MDR?
  12. Do manufacturers, which have lodged an application for conformity assessment and have concluded a written agreement with a notified body before 20 March 2023, have to lodge a new application and/or conclude a new written agreement?
  13. What are the necessary elements of the arrangement for the transfer of the surveillance from the notified body that issued the MDD/AIMDD certificate to the MDR notified body?
  14. What does the limitation ‘where practicable’ imply?
  15. Which notified body is responsible for carrying out the appropriate surveillance when a written agreement in accordance with Article 120(3c), point e, MDR is signed between the manufacturer and a notified body designated under the MDR?
  16. In case there is an arrangement for the transfer of the surveillance to a different notified body designated under MDR, what are the implication on the labelling concerning the notified body’s identification number?
  17. . Is the notified body, which issued the certificate in accordance with Article 120(3b) of Regulation (EU) 2017/745, legally obliged to continue to carry out the surveillance of the products concerned until the end of the new transitional period or until the manufacturer has transferred this surveillance obligation to a notified body whose designation has been made in accordance with Article 42? May this notified body deny the manufacturer the use of its NB number?
  18. Which devices will benefit from the removal of the ‘sell-off’ date?

Full Q&A Document: https://health.ec.europa.eu/system/files/2023-03/mdr_proposal_extension-q-n-a_0.pdf