Conditions attached to the extended MDR transition period

Regulation (EU) 2023/607 amended Regulation (EU) 2017/745 (MDR), extending the transition periods for certain medical devices. This extension is not automatic. It is contingent on meeting specific conditions, ensuring that devices continue to meet high safety and performance standards.

#Extended Transition Periods under Regulation (EU) 2023/607

Regulation (EU) 2023/607, adopted on 15 March 2023, introduced amendments to Article 120 of the MDR. This extended the transition periods for certain devices placed on the market under Directive 93/42/EEC (MDD) or Directive 90/385/EEC (AIMDD) that have a valid certificate issued by a notified body. The length of the extension depends on the device's risk class.

#New Deadlines for Legacy Devices

• 31 December 2027: For higher-risk devices, specifically Class III devices and Class IIb implantable devices, excluding sutures, staples, dental fillings, dental braces, root canal bypasses, or tooth crowns.
• 31 December 2028: For medium and lower-risk devices, specifically other Class IIb devices, Class IIa devices, and Class Is, Im, Ir devices.
• 26 May 2026: For Class I devices that require a notified body assessment for conformity with MDR (e.g., sterile or with measuring function) and for which the declaration of conformity was drawn up before 26 May 2021.

#Conditions for Eligibility

Article 120(3c) of the MDR, as amended by Regulation (EU) 2023/607, specifies the cumulative conditions for a device to benefit from these extended transition periods. These conditions ensure that only devices transitioning towards MDR compliance, and not posing an unacceptable risk, remain on the market.

Manufacturers of devices that continue to be placed on the market under the extended transition period must comply with the following requirements:

• Continuing MDD/AIMDD Compliance: The device continues to comply with Directive 93/42/EEC or Directive 90/385/EEC, as applicable (Article 120(3c)(a) MDR).
• No Significant Design Changes: There have been no significant changes in the design and intended purpose of the device (Article 120(3c)(b) MDR).
• No Unacceptable Risk: The device does not present an unacceptable risk to the health or safety of patients, users, or other persons, or to other aspects of public health protection (Article 120(3c)(c) MDR).
• QMS Implementation: The manufacturer has put in place a quality management system in accordance with Article 10(9) MDR by 26 May 2024 (Article 120(3c)(d) MDR).
• Formal Application: The manufacturer, or an authorised representative, has lodged a formal application for conformity assessment with a notified body for the device or for a device intended to substitute it, by 26 May 2024. A written agreement with the notified body must be concluded by 26 September 2024 (Article 120(3c)(e) MDR).

Distributors and importers must verify that their suppliers meet these conditions. They should request evidence of compliance from manufacturers, such as declarations of conformity, evidence of QMS implementation, and correspondence with a notified body regarding MDR application.

#Application of MDR Requirements during the Transition

Even for devices benefiting from the extended transition periods, certain MDR requirements apply. These include:

• Post-Market Surveillance: Requirements relating to post-market surveillance (PMS), market surveillance, vigilance, registration of economic operators, and registration of devices as laid down in Chapters III, VI, and VII of the MDR shall apply in place of the corresponding requirements in MDD/AIMDD (Article 120(3d) MDR).
• Obligations of Economic Operators: The obligations of economic operators, as specified in Articles 13, 14, and 16 of the MDR, apply to distributors and importers. This includes verifying that the device bears the CE marking, that the manufacturer has drawn up the EU declaration of conformity, and that the device is accompanied by the required information.

#EUDAMED Requirements

The full operational status of EUDAMED modules has been phased. Economic operators, including distributors and importers, should confirm the current status and scope of EUDAMED requirements with their national competent authority. This is essential for understanding their specific obligations regarding device and economic operator registration at any given time.

#Devices Not Eligible for Extension

Regulation (EU) 2023/607 also clarified that devices that were down-classified from Class I to Class IIa or IIb under the MDR, and for which a declaration of conformity was drawn up prior to 26 May 2021 without the involvement of a notified body, do not benefit from the extended transition periods. Such devices must meet the MDR requirements by 26 May 2024. Devices that did not have a valid MDD/AIMDD certificate before 26 May 2021 are also not eligible for the extended transition periods (Article 120(3) MDR).

#Common mistakes in practice

• Assuming all legacy devices automatically benefit from the extension without fulfilling the conditions specified in Article 120(3c) MDR.
• Failing to ensure the manufacturer has implemented an MDR-compliant Quality Management System by 26 May 2024.
• Not verifying that the manufacturer has lodged a formal application with a notified body by 26 May 2024 and secured a written agreement by 26 September 2024.
• Overlooking the immediate application of MDR post-market surveillance, vigilance, and market surveillance requirements for legacy devices.
• Distributors and importers not checking their supply chain for evidence of manufacturer compliance with the extension conditions, as required by Article 13 and 14 MDR.
• Failing to understand the specific deadlines for different risk classes of devices.

Note: This table summarises key dates. Specific exclusions apply, as detailed in Article 120(3a) MDR.

Compliance with the MDR and its transitional provisions is a continuous process. Distributors and importers play a crucial role in ensuring that devices placed on the market meet all applicable requirements. Further information about EUDAMED and its various modules can be found on our platform: EUDAMED AI platform.

This material is for information only and is not legal advice. For binding interpretation consult your national competent authority.