SCENARIO 1: CLINICAL INVESTIGATION REQUIRED
If the manufacturer determines that a clinical investigation involving an NB is necessary, the process is strict. The application for the investigation should have been submitted by June 22, 2024, with work commencing by December 23, 2024.
To ensure continuity, the contract with a Notified Body (NB) must be signed by January 1, 2028, with the aim of obtaining the CE certificate by December 31, 2029. During the transition, any significant change to the design or intended purpose is prohibited.
SCENARIO 2: WITHOUT CLINICAL INVESTIGATION
If the involvement of an NB is required but no clinical investigation is necessary, the timelines are slightly shorter. The manufacturer is required to sign the agreement with the Notified Body by January 1, 2027. The final deadline for MDR certification is set for December 31, 2028.
SCENARIO 3: LEGACY DEVICES (FORMER MDD)
For ‘legacy’ devices already covered by an MDD certificate, the standard MDR extension deadlines apply. The application to the NB should have been submitted by May 26, 2024, followed by the signing of the contract by September 26, 2024. Final certification must be obtained by 2027 for high-risk products (Class III and IIb implantables) or by 2028 for lower classes and specific exemptions.
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