How to demonstrate your eligibility to benefit from extended MDR transition

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Life sciences partner Lincoln Tsang and associate Hannah Kerr-Peterson from Ropes & Gray set out how manufacturers can demonstrate their eligibility to benefit from the amended MDR transition periods.

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To ease the medical device industry’s transition to Regulation (EU) 2017/745 (the Medical Device Regulation or MDR), earlier this year the European Parliament and Council adopted Regulation (EU) 2023/607 (the Amending Regulation). As previously reported, the Amending Regulation provides manufacturers with additional time within which to achieve MDR compliance, provided certain conditions are fulfilled.

Notwithstanding the positive legislative development, notified bodies are not expected to amend the expiry dates of certificates of conformity that they have issued under Directives 93/42/EEC and 90/385/EEC (the Legacy Directives) to reflect the extended deadlines provided for in the Amending Regulation. This could pose practical issues for manufacturers who are required to prove the lawfulness of the commercialisation of their devices in other commercial settings, for example, as part of a due diligence process in a corporate transaction, during a procurement procedure, or to gain market access in a third country which relies on the CE certification for importation and market access.

This note provides a brief overview of how manufacturers can demonstrate their eligibility to benefit from the amended MDR transition periods.

Ultimately, manufacturers need to obtain certificates of conformity under the MDR

Prior to a medical device being placed on the market, it must have undergone a conformity assessment and been CE marked. For higher risk devices, this assessment must be conducted by a notified body. After the successful completion of a conformity assessment, the notified body will issue a certificate of conformity, after which a CE mark can be affixed, and the device placed on the market.

Certificates of conformity issued by notified bodies under the Legacy Directives cannot be relied upon to demonstrate compliance with the MDR, meaning that all devices certified under the Legacy Directives (Legacy Devices) must undergo fresh conformity assessments under the MDR.

How to demonstrate eligibility to benefit from the extended deadlines for MDR compliance

The Amending Regulation extended the deadlines to provide manufacturers with additional time for transitioning Legacy Devices to a state of compliance with MDR. To benefit from the extensions, manufacturers must satisfy the conditions set out in Article 120(3c) of the MDR. In particular:

If these conditions are met, manufacturers can rely on certificates of conformity issued under a Legacy Directive, as a lawful basis for the commercialisation of the medical device in the EU. Where manufacturers are required to prove the lawfulness of their reliance on such certificates, the Amending Regulation provides that:

Practical implications for manufacturers

Device manufacturers who intend to rely on the extended transition periods are advised to amend their MDR transition plans to take account of the deadlines for making the arrangements described above.

If recent experience is anything to go by, the volume of requests for the execution of written agreements and the issuance of Confirmation Letters could be expected to increase as the deadlines approach. Accordingly, to ensure business continuity, it is advisable for manufacturers to make these arrangements in good time.

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