ARTICLE SUMMARY:
In this edition of Consultants Corner, Bassil Akra, of AKRA Team, implores device companies not to delay the chase for MDR certification even though transition times are about to be extended. If your firm, however, will need to leverage the new timelines, do the work, declare conformity, and avoid asking unnecessary questions, he advises.
Welcome to Consultants Corner, where we check in with independent experts about questions they are answering or challenges they are solving for clients on the front lines of medtech regulatory, reimbursement, and market access.
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Bassil Akra (bassil.akra@akrateam.com) is CEO of AKRA Team, which he founded in 2021 as a consultancy to support companies’ efforts with the MDR and IVDR. He previously worked for the largest EU notified body, TÜV SÜD Product Service, most recently as VP of strategic business development of global medical health services. He has also represented the EU notified body association as part of the implementation of the new EU regulations and in the development of related guidance documents. |
The Question: My CE Mark Certificate Has Expired, Now What?
Let’s say your firm has submitted documentation to a notified body for a conformity assessment under the EU Medical Device Regulation, but the clock is ticking and you’ve had no reply. Or, the NB has come back with a response asking for a battery of unexpected testing and now your company is waiting for support from an over-taxed external laboratory. In the interim, the validity period on your CE mark lapses.
These are becoming increasingly common occurrences for companies and it’s only going to get worse through May 2024, when the last certificates granted under the legacy EU directives expire. To be sure, manufacturers should be doing absolutely everything in their power to avoid this predicament, says Bassil Akra, whose consulting firm, AKRA Team, advises companies on the intricacies of the EU MDR and IVD Regulation. “I do not recommend that any manufacturer take a break now,” he stresses.
