Jun 17, 2022

The European Commission’s Medical Device Coordination Group (MDCG) has published a new position paper recommending that manufacturers currently transitioning to full Medical Devices Regulation (MDR) compliance step up efforts in order to avoid losing their CE Mark certifications and therefore access to the European Union market.

The MDCG paper focuses on device manufacturers whose CE Marking under the EU Medical Devices Directive (MDD) or Active Implantable Medical Devices Directive (AIMDD) are set to expire in 2023 or 2024, at which point their devices will require certification to the MDR in order to remain on the EU market.

MDCG cites recent survey data from Notified Bodies suggesting that many manufacturers transitioning from MDD and/or AIMDD certification to the MDR by their May 26, 2024 deadline have much to do in order to meet new compliance obligations. Key findings identified by the MDCG paper include:

  • More than 90% of currently valid MDD and AIMDD certificates will expire in 2023 or 2024
  • 75% of all Notified Bodies have reported that more than half of all applications from manufacturers have been found incomplete
  • Manufacturers running the risk of not obtaining valid certification to the MDR by the May 2024 deadline could ultimately result in device supply shortages

“It should be noted that around 70% of AIMDD/MDD certificates will expire in 2024 (by 26 May 2024 at the latest),” notes the MDCG paper. “Manufacturers should take into consideration that it might not be possible that notified bodies designated under the MDR would be able to assess all corresponding files within the first months of 2024.”

MDR Article 59 to the rescue?

Article 59 of the MDR allows for derogation from the Regulation’s conformity assessment requirements, but only in certain, specific instances, notes the MDCG paper. However, many manufacturers relying on Article 59 as an emergency option if their MDR transition efforts are not completed in time may find that their devices do not qualify for this route.

EU Competent Authorities grant derogation from MDR conformity assessment procedures only in the following cases:

  • The use of the device in question is in the interest of public health, patient safety or patient health, plus:
    • The manufacturer can show that all reasonable efforts have been taken to transition to the MDR
    • The manufacturer has submitted an application for Notified Body certification to the MDR at least one year before the organization’s MDD or AIMDD certification is set to expire

Furthermore, the MDCG warns that regulators will not accept “economic grounds alone” as a qualification for Article 59 derogation.

Instead, the MDCG paper recommends that manufacturers focus on system adjustments, finalizing transitions to the MDR and applying to MDR-designated Notified Bodies for certification “as soon as possible” ahead of the May 26, 2024 transition period deadline.

Additional EU MDR compliance resources from Emergo by UL:

Author

  • Annette van Raamsdonk and Stewart Eisenhart

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