The initial document of the Q&A, released in late March, provided guidance for the amendment to the extension in transitional provisions. This document was well received by many entities within the regulatory space. There has been an update to the Q&A document that has been released in mid-July. The document conveniently includes a change history that details the changes that have been made when compared to the March version. Most notably, the changes have been concerning the following:
- Flowcharts will be made available by the EU Commission to assist manufacturers and other relevant actors in deciding whether or not a device is covered by the extended transitional period provided for in Article 120 MDR.
- Clarification of what constitutes a withdrawal of a certificate. The document states that a notified body letter informing about the expiry of the certificate, or a controlled phase-out of production agreed between notified body and manufacturer due to the expiry of a certificate prior to 20 March 2023, is not considered to be a withdrawal of a certificate.
- Inclusion of links to the self-declaration templates, template for the confirmation of the notified body and updated fact sheet for Competent Authorities of Non-EU/EEA countries
- Clarification of the preferred format for submitting information to the notified body. The document stressed that since these submissions require the possibility for the notified body to add the relevant digital document/documents to its files, a ‘read-only’ access to the manufacturer’s electronic data platform is not sufficient.
- The need for the manufacturer to inform the notified body about the devices that will be subject to the appropriate surveillance by the notified body. Additionally, they would need to inform them where surveillance activities have not been continued, e.g. due to the expiry of the certificate before 20 March 2023.
There has also been an addition of questions, most notably:
- Question 6.1: Does a national derogation granted in accordance with Article 59 MDR, or the application of Article 97 MDR, after 20 March 2023 trigger the extension of the transitional period?
- Question 6.2: Can a device for which a derogation was granted in accordance with Article 59 MDR benefit from the transitional period even though it was required to not bear a CE marking?
- Question 9.1: What happens if the application is withdrawn, or the written agreement terminated?
- Question 9.2: What is the impact of changes related to the manufacturer during the transitional period?
- Question 11.1: Do legacy devices have to comply with UDI requirements during the extended transitional period?
The updated Q&A document can be accessed using the following link
