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Countdown Commences for Legacy Medical Device Manufacturers to Benefit from the MDR Transition Period Extension

May 2, 2024

As the medical device industry adapts to the evolving regulatory landscape, a critical deadline approaches for legacy medical device manufacturers to take advantage of the extended transition period for Regulation (EU) 2017/745 (MDR) compliance.

 

The European Union’s Regulation (EU) 2023/607, issued on 15 March 2023 and published five days later, grants an extension for certificates pertaining to legacy devices—those in conformity with Directive 90/385/EEC (AIMDD) or Directive 93/42/EEC (MDD) that are placed on the market after the MDR’s date of application (i.e. 26 May 2021).

 

Important Deadlines:

  • 26 May 2024: Deadline for manufacturers to have filed a formal application for MDR conformity assessment to a notified body.
  • 26 May 2024: Manufacturers must also have implemented a quality management system compliant with Article 10(9) of the MDR.
  • 26 September 2024: A signed agreement with a notified body must be submitted for the extension to apply.

 

Additional conditions to benefit from the transition periods include:

  • Devices continue to comply with AIMDD or MDD, as applicable;
  • There are no significant changes in design and intended purpose;
  • Devices do not present an unacceptable risk to patient, user or public health safety;

 

Remember, if your CE certificate under AIMDD or MDD has expired, you can prepare a self-declaration confirming compliance with the conditions mentioned above to benefit from the transition period proposed in Regulation (EU) 2023/607. Request this declaration from your notified body or use the template jointly developed by AESGP, COCIR, EuromContact, EUROM VI Medical Technology, and MedTech Europe.

 

Transition Period Deadlines

 

Transition DeadlineAffected Devices
26 May 2026Custom-made implantable devices in class III
31 December 2027Higher-risk devices

This includes Class III devices and Class IIb implantable devices, excluding sutures, braces, dental fillings, dental braces, dental crowns, screws, wedges, plates, wires, pins, clips and connectors.

31 December 2028Medium and lower risk products

This includes other class IIb products, class IIa products and products of classes ls, lm, lr.

No extensionClass I devices (other than ls, lm, lr)

 

The sell-off period for existing products has also been abolished to allow medical devices already placed on the market to be made available beyond the original date of May 2025; without any limitation in time without prejudice to the device’s possible shelf-life or expiry date.

 

Useful Resources

 

Stay informed and prepared to ensure a seamless transition to the MDR.

Contact us for any queries: medtech@asphalion.com

 

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