Impact of the European Union Medical Device Regulation Extension on Legacy Devices

Question: The European Union (EU) has extended the transition period for medical devices under the Medical Device Regulation (MDR) and removed the sell-off provisions for existing products. How do these changes impact you?

Answer: On 7 March 2023, the European Council voted to adopt a measure to extend the transitional period for medical devices under the European Union Medical Device Regulation (MDR). The extension is intended to address the risk of shortages of critical medical devices due to low notified body capacity. The extension provides manufacturers and notified bodies alike with added breathing room to effectively transition to MDR from current MDD Certificates.

The extension applies to legacy devices of all classes. Legacy devices are those placed on the market after the MDR’s date of application until 26 May 2024 that:

• Class I devices under Medical Devices Directive (MDD), for which (1) a declaration of conformity was drawn up prior to 26 May 2021, and (2) for which the conformity assessment procedure under the MDR requires the involvement of a notified body
• Devices covered by valid EC certificates issued under MDD prior to 26 May 2021.

Class III and IIb implantable devices have until December 2027; Class IIb non-implantable devices, Class IIa and Class I devices have until December 2028. Class III custom-made implantable devices would have until May 2026.

Q: Will devices be issued a new certificate?

A: No. If a legacy device is eligible for the extension, it will be extended provided the conditions laid down in Article 120(3) are fulfilled (more on that below). No new certificates will be issued. Notified bodies can provide written confirmation correcting or complementing information on an existing certificate. This is important in situations where a manufacturer may need to demonstrate validity of the certificate to third parties, for example.

Competent authorities should be able to issue certificates of free sale for the duration of the extended certificate validity as well.

Q: What do I need to do to benefit from the extension of MDR transition period?

A: A manufacturer or the authorised representative must lodge a formal application for conformity assessment in accordance with Section 4.3, first subparagraph, of Annex VII MDR no later than 26 May 2024. The manufacturer and notified body must finalize and sign a written agreement on the extension no later than 26 September 2024.

A full review of the application by the notified body is not required before the signature of the written agreement. While this relieves some of the burden, the manufacturer must still provide certain required elements and documentation for extension.

Q: Does that mean manufacturers must continue to comply with the MDD during the transition period?

A: Yes, but under Article 120(3) of the MDR, the manufacturer will still be required to comply with parts of the MDR during the transition period. It is critical for manufacturers to understand what requirements apply, such as the prohibition of significant changes in the design and intended purpose during the transition period.

Manufacturers must also resist the temptation to ease up on efforts towards MDR transition in the meantime. There remains a shortage of notified body capacity to review and certify new and legacy devices. The shortage may cause delayed acceptance of medical device technical documentation review and longer review periods, which may exceed 12 months.

Q: What does moving forward look like?

A: The EU MDR extension gives both manufacturers and notified bodies badly needed breathing room for the transition without removing critical medical devices from the market. At the same time, the extension does come with specific conditions and imposes some MDR requirements during the transition.

It is also important for manufacturers to not slow down their work toward transitioning to MDR compliance. Workloads on notified bodies will remain burdensome, making it difficult for them to review applications in a timely manner. It is also expected that application review timelines may be 12 months or more. Therefore, it is important for manufacturers to stay focused on MDR transition until completion.

Q: How can EVERSANA’s Regulatory Consulting help you?

A: If you have a legacy device, our team of regulatory experts can help you to understand your compliance requirements and devise an effective strategy that ensures your device remains on the market. We can assist you with all phases: from assessing extension implications to developing and implementing a compliance strategy. We are your partner every step of the way, from updating QMS to liaising with authorities and notified bodies. Let us help with technical documentation, post-market surveillance, and conformity assessments, so you can focus on your business with confidence.