EU MDR Extension 2027–28: What You Need to Know
Introduction to EU MDR
When it comes to placing medical devices on the market in the European Union, the Medical Devices Regulation (EU MDR) has replaced the previous Medical Device Directive (93/42/EEC). The initial transition period was set to end on 26 May 2024, but recent updates regarding the EU MMDR Extension have provided medical device manufacturers with additional time to achieve compliance. Understanding the details of the EU MDR Extension is critical for companies navigating this regulatory shift.
Elexes guided 50+ manufacturers through EU MDR extension compliance, ensuring CE continuity. As RA/QA heads, you must act now to ensure your device remains CE-certified through 2027–28.
Extension of the EU MDR Transition period
The European Commission proposed an extended transition time on January 6, 2023, based on the risk classification of the medical device.
The standards for safety and performance set out in the EU MDR will not be altered by this extension. Manufacturers are essentially given extra time to adapt their processes to the regulation’s new requirements.
Why Was the MDR Timeline Extended?
⦿ To prevent the shortage of devices in the European countries
⦿ To provide more time for the manufacturers to get certified by the Notified Bodies (NBs) under new applicable regulations
⦿ To allow more NBs to qualify to be eligible for conducting an MDR review
New MDR Transition Deadlines: Who Qualifies?
⦿ From May 26, 2024 to Dec 31, 2027 for Class III, Class IIB implantable devices
⦿ From May 26, 2024 to Dec 31, 2028 for Class IIB non-implantable, Class IIA, and Class I devices
This applies to medical devices covered by a certificate or a Declaration of Conformity (DoC) issued before May 26, 2021.
Under this proposal, manufacturers of Class III implantable custom-made devices would have until May 26, 2026, to get certified by an NB.
Certificates issued before the MDR’s implementation in the European Union on May 26, 2021, would have their expiration dates extended under the new proposal.
The Commission also intends to eliminate the “sell-off” deadline imposed under MDR and IVDR that mandates the needless disposal of some safe medical equipment.
Need Help?
FAQs
What are the new EU MDR extension deadlines?
Class III and Class IIb implantable devices are extended until December 31, 2027. Class IIb (non-implantables), IIa, and Class I (sterile or measuring) devices are extended to December 31, 2028.
Which manufacturers are eligible for the EU MDR transition extension?
Manufacturers with compliant QMS and Notified Body agreements in place by May 26, 2024, are eligible. Devices must also continue to meet MDD/AIMDD standards and not pose an unacceptable risk.
Was the 'sell-off' period removed under the new MDR changes?
Yes. The EU removed the sell-off provision, allowing devices placed on the market prior to 26 May 2021 in accordance with the MDD/AIMDD or after 26 May 2021 during the transitional period provided for in Article 120 MDR (i.e. until 31 December 2027 or 31 December 2028, as applicable) may continue to be made available on the market or put into service without any limitation in time without prejudice to the device’s possible shelf-life or expiry date.
Does the EU MDR extension affect the EUDAMED timeline?
EUDAMED remains under phased implementation and is not directly impacted by the MDR deadline extension, though full compliance will eventually require EUDAMED integration.
How can I prepare for MDR compliance now?
To prepare for MDR compliance, manufacturers should first ensure that they already fulfilled the MDR extension eligibility criteria, including having an MDR-compliant QMS and a formal MDR application by may 2024 and signed agreement with a Notified Body by Sept 2024.
