March 27, 2023

EU MDR Transitional Extension Regulation (EU) 2023/607 and Previously-Expired MDD/AIMDD Certificates

Even if an MDD/AIMDD certificate from 25 May 2017 expired before Regulation (EU) 2023/607’s March 15 (20?), 2023 entry into force, and as long as it wasn’t “withdrawn” for cause (e.g., see EU MDR Annex IX.3.7), then placing on the market may continue provided that either a) the manufacturer and an EU MDR notified body had, prior to MDD/AIMDD certificate expiry, executed a written agreement (contract) formalizing (among other things) the parties’ mutual intentions for EU MDR conformity assessment later in due course, or b) the manufacturer has received an exception from the CA under either EU MDR Article 59(1) or Article 97(1). (On that note, I don’t believe Article 97 offers a way for the manufacturer to apply for the Article 97 exception; instead, Article 97 is a market surveillance-driven mechanism initiated/driven by notified bodies and competent authorities.  Accordingly, I’d say that Article 59(1) is the proper route if a manufacturer wishes to actually apply/lobby for an exception apart from an Article 97 for-cause scenario.)

Additional immediate conditions for continuing to place such expired-MDD/AIMDD certificate devices on the Union market are:

• those devices continue to comply with Directive 90/385/EEC or Directive 93/42/EEC, as applicable,

• there are no significant changes in the design and intended purpose,

• the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health,

• EU MDR requirements for post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in Directives 90/385/EEC and 93/42/EEC, and

• the notified body that issued the expired MDD/AIMDD certificate must continue to be responsible for the appropriate surveillance audits unless the manufacturer has agreed with an EU MDR notified body who will instead carry out such surveillance.

Finally, as of 26 May 2024, an additional condition will apply, namely that the manufacturer has put in place a quality management system in accordance with Article 10(9).

Additional requirements or exceptions to these provisions may apply regarding class III custom-made implantable devices and regarding deadlines for transition of surveillance auditing from the MDD/AIMDD notified body to an EU MDR notified body.