Extending MDR/IVDR Transitional Period and Eliminating ‘Sell-Off’ Periods – (EU) 2023/607

The European Parliament and Council have put Regulation (EU) 2023/607 into effect on March 20, 2023. This new Regulation modifies Regulations (EU) 2017/745 and (EU) 2017/746, which pertain to the transitional period for medical devices and in vitro diagnostic medical devices. The Regulation eliminates the ‘sell-off provision’ for both the MDR and IVDR while outlining specific conditions for the extension provision to apply.

Regulation (EU) 2023/607 Criteria

The criteria for the extension to be applicable to medical devices include the following:

1. The devices must comply with Directive 90/385/EEC (AIMDD) or Directive 93/42/EEC (MDD) without any significant changes in design or intended purpose.
2. The device must not pose any unacceptable risks to the health or safety of patients, users, or other persons or any other aspect of public health protection.
3. The manufacturer must have a Quality Management System (QMS) in place, complying with Art 10(9) by May 26, 2024, at the latest.
4. The manufacturer or authorized representative must lodge a formal application for conformity assessment for MDR certification to a notified body by May 26, 2024. A written agreement between the manufacturer and the notified body must be signed by September 26, 2024.
5. The manufacturer or authorized representative for all the devices must comply with the MDR Article 120 requirements related to Post-Market Surveillance (PMS), vigilance, trend reporting, market surveillance, and registration of actors and devices since May 26, 2021.

Expansion of the Transitional Provisions of the MDR

The Regulation also expands the transitional provisions of the MDR. Class III (Class III custom-made implantable devices) has until May 26, 2026, while devices covered by valid MDD/AIMDD Certificates (as of March 20, 2023), and Class IIb implantable devices excluding well-established technologies (WET) under MDR have until December 31, 2027. Devices covered by valid MDD/AIMDD Certificates (as of March 20, 2023), and that are Class IIb devices (excluding Class IIb implantable non-WET), or Class IIa devices, or Class I sterile devices, or Class I devices with measuring function have until December 31, 2028.

IVD Changes with Regulation (EU) 2023/607

In addition, manufacturers of IVDs can continue to market and service their devices if they issued a declaration of conformity before May 26, 2022, and made no significant changes to the device’s design or intended purpose. They must have established PMS and vigilance following the IVDR and registered in EUDAMED. Class D devices have a new transition date of May 26, 2025, while Class C devices have a date of May 26, 2026. Class B devices have a transition date of May 26, 2027, and Class A sterile devices have a date of May 26, 2027. Non-sterile self-declared devices and all new devices have a transition date of May 26, 2022.

Key Take Away for Manufacturers from Regulation (EU) 2023/607

As we transition to the new regulatory framework, we want to provide you with essential cautions to ensure a smooth and successful process.

1. Firstly, please be aware that the capacity of notified bodies to support this transition is limited overall. To avoid any last-minute surprises, we strongly advise you to submit a formal application for MDR certification to a notified body no later than May 26, 2024.
2. Additionally, it is crucial to note that the MDR requirements, such as PMS, market surveillance, vigilance, and registration of economic operators and devices, will apply to the “extended” devices instead of the corresponding requirements of the MDD and AIMDD.

We hope you find this information helpful in ensuring compliance with the new regulatory framework. Please feel free to reach out to us with any questions or concerns.