Today the EU Commission updated the MDR Transition Extension Q&A. The updated version is available: HERE
The Q&A provides practical guidance on how to apply the MDR extension under EU Regulation 2023/607. For example:
The Q&A clarifies some of its earlier statements, for example:
“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.”
A template jointly developed by industry associations (AESGP, COCIR, EuromContact, EUROM VI, and MedTech Europe) for manufacturers is now available. The purpose is to self-assert compliance with the MDR transition extension period. It consists of two parts:
The template is available: HERE
The EU Commission has updated its MDR Factsheet, to reflect the later dates. It is available: HERE
The Factsheet is targeted at international regulators, to explain the extension. It may be helpful to manufacturers if they are struggling to show non-EU regulators that rely on EU marketing approval (e.g., Middle East, LatAm countries), that the expired CE certificate is still valid.
The Q&A now includes the following:
