Following amending Regulation (EU) 2023/607 on the extended transition period for medical devices under the MDR and removal of sell-off periods under the MDR and IVDR, the European Commission has set up a Q&A document to provide guidance on the most urgent questions.
The document addresses 17 questions:
- Which devices can benefit from the extended transitional period?
- Can devices that have already been certified in accordance with the MDR benefit from extended transitional period?
- What about ‘legacy devices’ for which the manufacturer does not wish to apply under the MDR?
- Which classification rules apply to determine whether the extended transitional period ends on 31 December 2027 or on 31 December 2028?
- Does the extended transitional period also apply to custom-made devices?
- 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?
- How can the manufacturer demonstrate that its legacy device benefits from the extension of the transitional period?
- What are the necessary elements of a formal application lodged by the manufacturer?
- What are the necessary elements of a written agreement between the manufacturer and the notified body?
- What is the meaning of “device intended to substitute that device”?
- Which evidence does the manufacturer have to provide for having put in place a QMS in accordance with the MDR?
- 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?
The remaining five questions relate to scenarios where a manufacturer changed the notified body for the MDR conformity assessment and to the sell-off period.
While some of the answers seem to convey obvious details, others provide valuable information. For example, the answer on question 7 suggests a self-declaration issued by the manufacturer in combination with a confirmation by the notified body and potentially a certificate of free sale by the competent authority.
It remains to be seen in how far the suggestions can be established in practice. Should you wish mdi Europa to submit the Q&A document or if you need further advice, please let us know.
Source: European Commission, Medtech Insight (an Informa product)
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