The European Commission has published a first revision of its Q&A document regarding the implementation of the amending regulation (EU) 2023/607 to the medical devices regulation (MDR).
Updates have been made to section 7 on how a manufacturer can demonstrate that its legacy device can profit from the extension of the transition period. The original document had stated that associated confirmation letters should be based on a harmonised template. In the most recent revision, the document says that the manufacturer could also demonstrate having applied for conformity assessment and arranged a written agreement with a notified body by another method, for example, a copy of the relevant document.
In addition, new appendices have been added linking with a template for a manufacturer’s declaration and a template for notified body confirmation letter.
Other changes generated by additions to Q&As in the original text are among others:
- A notified body letter notifying about the expiry of the certificate, or a controlled phase-out of production agreed between notified body and manufacture because of the expiry of a certificate before 20 March 2023 are not deemed as withdrawal of a certificate.
- As regards the information presented by the manufacturer or the authorised representative with their formal application to a notified body for conformity assessment under the MDR as a step being able to take advantage of the extended transitional period, the submission of information requires the possibility for the notified body to add the relevant digital document(s) to its files. Consequently, a ‘read only’ access to the manufacturer’s electronic data platform is not enough.
- To facilitate the notified body to complete the surveillance and make the required arrangements with the manufacturers, a previous notified body must advise any new notified body that is involved with the same device about the device(s) requiring appropriate surveillance, especially when surveillance activities have not been ongoing, for instance, if the certificate expired before 20 March 2023.
Further considerations include but are not limited to:
Section 6.1. asks if a national derogation granted in accordance with article 59 of the MDR, or the application of article 97 under the MDR, after March 2023 trigger the extension of the transitional period. The answer is no. Where after 20 March 2023, a competent authority has consented to a derogation in accordance with article 59, or has insisted on, in line with article 97, to perform the applicable conformity assessment procedure, the conditions for the extended transition period is not met. So, an expired certificate will not be deemed as valid.
The original Q&A document was made public on March 24 and is intended for companies wanting to take advantage of the extended transition periods for their legacy products.
Source: Medtech Insight (an Informa product)