EU Extends Transition Period for Medical Devices from MDD to MDR Until 2027/2028

EU Extends Transition Period for Medical Devices from MDD to MDR Until 2027/2028

May 5, 2025

In response to industry challenges and to prevent potential shortages of medical devices, the European Union has officially extended the transition period for compliance with the Medical Device Regulation (MDR) (EU) 2017/745. This extension, enacted through Regulation (EU) 2023/607, allows certain medical devices certified under the previous Medical Device Directive (MDD) to remain on the market beyond the original deadline, provided specific conditions are met.(simmons-simmons.com, Home // Cooley // Global Law Firm)

Key Provisions of the Extension:

• Extended Deadlines Based on Device Risk Class:

  • High-risk devices (Class III and certain Class IIb implantable devices): Transition period extended until December 31, 2027.

  • Medium- and low-risk devices (Class IIb non-implantable, Class IIa, and certain Class I devices): Transition period extended until December 31, 2028. (DQSGLOBAL, Network Partners Group)

• Conditions for Extension Eligibility:

  • Devices must have had a valid MDD certificate as of May 26, 2021, and the certificate must not have been withdrawn.

  • Manufacturers must have submitted a formal application for MDR conformity assessment by May 26, 2024, and signed a written agreement with a Notified Body by September 26, 2024.

  • Devices must continue to comply with MDD requirements without significant changes in design or intended purpose.

  • Manufacturers must implement MDR requirements related to post-market surveillance, market surveillance, vigilance, and registration of economic operators. (DLRC, Eversana, BSI)

• Removal of the 'Sell-Off' Period:
  The previous 'sell-off' period, which required devices placed on the market before May 26, 2021, to be withdrawn by May 26, 2025, has been eliminated. This change allows such devices to remain available on the market without a fixed end date, provided they meet the necessary conditions. (DLRC)

Implications for Manufacturers:

This extension provides manufacturers with additional time to achieve full compliance with the MDR, addressing concerns about the capacity of Notified Bodies and the potential for device shortages. However, it is crucial for manufacturers to adhere strictly to the outlined conditions to benefit from the extended transition period.(Eversana)

Manufacturers are encouraged to proactively engage with Notified Bodies, ensure timely submission of conformity assessment applications, and maintain rigorous compliance with both MDD and applicable MDR provisions during this transitional phase.(DLRC)

For more detailed information, refer to the full text of Regulation (EU) 2023/607: EUR-Lex Document