The European Commission’s Q&A, Revision 2 of July 2024, clarified that if a medical device manufacturer terminates its relationship with a Notified Body and simultaneously transfers its application to another Notified Body (also designated under the MDR), the conditions for accessing the transitional period are still fulfilled.

For instance, a manufacturer could benefit from the increased capacity available at a different Notified Body than the one to which the initial application was submitted at the start of the transitional period.

ECM DESIGNATION SCOPE UPDATED: EXTENSION TO CERTAIN CLASS III DEVICE TYPES

With the directorial decree dated December 4, 2025, ECM’s scope of designation was updated, extending it to certain types of Class III devices. ECM’s full scope of designation is available on the NANDO system.

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