MDR Transitional Period Extension: Key Regulatory Insights for Medical Device Compliance

The MDR Transitional Period Extension, introduced by EU Regulation 2023/607, offers medical-device manufacturers critical additional time to comply with the Medical Device Regulation (EU) 2017/745. This amendment addresses the urgent need to prevent device shortages while maintaining safety and performance requirements in the EU healthcare system.

Updated MDR Certification Deadlines

• May 26 2026: Class III custom-made implantable devices

• December 31 2027: Class III and selected Class IIb implantable devices (excluding sutures, staples, dental fillings, braces, etc.)

• December 31 2028: Other Class IIb, Class IIa, and specified Class I devices (e.g., sterile or measuring function)

Regulatory Requirements for Transitional Period

To maintain regulatory compliance during the MDR transitional period, manufacturers must:

• Ensure ongoing compliance with MDD (93/42/EEC) or AIMDD (90/385/EEC)

• Implement an MDR-compliant Quality Management System (QMS) by May 26 2024

• Submit a formal MDR application to a notified body by May 26 2024

• Sign a written agreement with a notified body by September 26 2024

These steps are essential to continue placing legacy devices on the EU market under the transitional provisions.

What Are Legacy Medical Devices?

Legacy devices are those that:

• Were certified under MDD or AIMDD

• Have not undergone significant changes in design or intended use

• Are transitioning to MDR compliance under Article 120(3c) conditions

These devices do not require full MDR certification during the transitional period but must remain under notified-body surveillance for post-market activities, vigilance, and registration.

Role of the Written Agreement with Notified Bodies

A written agreement, as required by Article 120(3c)(e) of the MDR, establishes the formal relationship for MDR conformity assessment. This agreement must:

• Be based on a complete MDR application

• Include a documented timeline for technical-file submission

• Be signed before detailed application review begins

• Optionally include a surveillance transfer if changing notified bodies

The agreement legally validates continued market access under the transitional extension.

Why MDR Transitional Period Documents Are Used Instead of EC Certificates

Regulatory professionals may encounter transitional-extension documentation rather than new EC certificates because:

• Certificates are automatically extended by law under Article 120(3c)

• Manufacturer self-declaration confirms compliance with MDR-extension conditions

• These documents serve as valid proof of compliance for import and distribution

• Many manufacturers are mid-transition and not yet required to finalize full MDR certification

Elimination of the “Sell-Off” Deadline

The “sell-off” provision has been removed, meaning devices placed on the market under the MDR transitional extension may be sold indefinitely, eliminating previous expiration-based constraints.

Conclusion

The MDR transitional-period extension under Regulation (EU) 2023/607 is a vital regulatory development for medical-device manufacturers and importers. It ensures continued market access for legacy devices while giving manufacturers time to complete their MDR certification process. Regulatory-affairs professionals must stay aligned with these updated timelines and compliance obligations to support uninterrupted market activity and maintain product conformity across the EU.