How to demonstrate your eligibility to benefit from the extended MDR change

Life Sciences Partner Lincoln Tsang and Ropes & Gray Partner Hannah Kerr-Petersen set out how manufacturers can demonstrate their eligibility to benefit from the revised MDR transition period.

To ease the transition to Regulation (EU) 2017/745 (the Medical Device Regulation or MDR) for the medical device industry, earlier this year the European Parliament and the Council adopted Regulation (EU) 2023/607 (the Amending Regulation). As stated earlier, the amended regulations provide additional time to manufacturers within which to achieve MDR compliance, provided certain conditions are met.

Despite positive legislative developments, notified bodies are not expected to amend the expiry dates of certificates of conformity issued under 93/42/EEC and 90/385/EEC (legacy directives) to reflect the extended deadlines Can go Revision Regulation. This can pose practical problems for manufacturers who need to prove the legality of commercializing their devices in other business settings, for example, as part of a due diligence process in a corporate transaction, a during the procurement process, or to obtain market access in a third country that relies on CE certification for importation and market access.

This note provides a brief overview of how manufacturers can demonstrate their eligibility for benefits from the revised MDR transition period.

Ultimately, manufacturers are required to obtain a certificate of conformity under the MDR

Before a medical device can be placed on the market, it must undergo a conformity assessment and be CE marked. For high risk equipment, this assessment must be carried out by a notified body. After successful completion of the conformity assessment, the notified body will issue a certificate of conformity, after which a CE mark can be affixed and the equipment can be placed on the market.

Certificates of Conformity issued by Notified Bodies under Legacy Directives cannot be relied upon to demonstrate compliance with the MDR, which means that all devices certified under the Legacy Directive (Legacy Devices) cannot be certified under the new MDR Must undergo conformity assessment.

How to demonstrate eligibility to avail the benefit of extended time limit for MDR compliance

The amended regulation extended the deadline to provide additional time to manufacturers to convert legacy equipment into MDR compliance. To benefit from the extension, manufacturers have to fulfill the conditions prescribed in Article 120(3c) of the MDR. especially:

• Legacy devices must continue to comply with the relevant Legacy Directive. In other words, it must benefit from a certificate of conformity issued under the relevant legacy directive, and must not be withdrawn by the notified body that issued this certificate.
• There should not be any significant change to the design or intended purpose of the legacy device. It’s worth noting that the guidance published by the Medical Device Coordination Group (MDCG) explaining what changes to a device would be considered “significant” has recently been updated.
• Legacy devices must be secure. More specifically, it must 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.
• By 26 May 2024, the manufacturer has to set up a Quality Management System (QMS) as per Article 10(9) of the MDR.
• By 26 May 2024, the manufacturer (or authorized representative) must file a formal application with a notified body for conformity assessment of the legacy device and its QMS. In accordance with guidance published by the European Commission, this application does not need to contain complete technical documentation, but it must clearly identify the manufacturer, the devices and their classification and the chosen conformity assessment procedure.
• By 26 September 2024, the notified body and the manufacturer shall have signed a written agreement, which, among other items, requires the manufacturer to notify the notified body of any vigilance reports, and to suspend, restrict or withdraw certificates Determines the right of the notified body to withdraw. has been issued, and it is the duty of the notified body to fulfill its notification obligation. It should also include an indication of a possible schedule for the submission of documents not provided at the time of application submission (eg completed technical documentation).

If these conditions are met, manufacturers can rely on the Certificate of Conformity issued under the Legacy Directive as a legal basis for commercializing the medical device in the EU. Where manufacturers are required to prove the validity of their reliance on such certificates, the amended Regulations provide that:

• Manufacturers should prepare a self-declaration that confirms that the conditions (described above) for the equipment concerned are satisfied.
• Manufacturers must request their notified body to issue a ‘confirmation letter’ confirming that the manufacturer has submitted a formal application for conformity assessment under the MDR, that a written agreement has been made between the parties, and That a suitable QMS is in place. A template for this letter has recently been published by the European Association for Medical Devices of Notified Bodies. According to guidance published by the European Commission, letters of conformity should, in principle, be issued free of charge.

practical implications for manufacturers

Device manufacturers who wish to rely on the extended transition period are advised to amend their MDR transition plans to take into account the setup deadlines described above.

If recent experience is anything to go by, the volume of requests for execution of written agreements and the time frame for issue of confirmation letters can be expected to increase. Accordingly, to ensure business continuity, manufacturers are advised to make these arrangements in due course.