Update for EU Amending Regulation and Regulators Who Leverage CE Marking Certificates

By Razel Cada, Megan Gottlieb and Evangeline Loh

Regulators are scrambling to confirm that their provisions regarding leveraging CE Marking Certificates are sufficiently aligned to Regulation 2023/607 by the May 26, 2024 deadline.

Regulation 2023/607

Regulation 2023/607 amended the EU Medical Devices Regulation (2017/745, MDR) to grant more time for legacy medical devices to become compliant with the MDR.

The first deadline is swiftly approaching, May 26, 2024. Manufacturers must secure an application with a Notified Body to review the legacy device (or a substitute device) to the MDR. We at Emergo by UL have written extensively on this topic, so this is not intended to serve as an update on the European situation. The next due date is September 26, 2024, for the agreement with the Notified Body to be in place.

Regulatory leveraging of compliance to the EU MDR

We have also recently featured global harmonization and leveraging regulatory authorizations as regulatory strategy topics. It is important to consider the consequences related to the impact of Regulation 2023/607 on other jurisdictions, including Malaysia.

With the delay of compliance requirements for legacy medical devices in the EU, regulators who accept authorizations to the MDR (CE Marking) are also impacted.

For the most part, these regulators have embraced the deadlines established in Regulation 2023/607 for securing the MDR CE Marking Certificate: end of December 2027 for Class III and implantable Class IIb devices and end of December 2028 for all others, including the devices that were Class I self-certified to the Medical Devices Directive (MDD) and are up-classified per the MDR.

Updated regulators list

We previously reported on the following regulators who had acknowledged additional time: SwissMedic, Israel Ministry of Health, UK MHRA, Australia TGA and Malaysia MDA. Here we share additional related content.

In the UK, The Medical Devices (Amendment) (Great Britain) Regulations 2023 was published in June 2023 to extend the deadlines for acceptance of CE Marking in Britain. One difference with Regulation 2023/607 is that the MHRA moved up the date from the end of 2028 to the end of June 2028.

In Switzerland, an amendment was posted at the end of September that became effective November 1. The Medical Devices Ordinance (MedDO) and Ordinance on In Vitro Diagnostics (IvDO) was revised. In particular, Article 101 of the MedDO was edited to include the dates in Regulation 2023/607.

In Israel, the Ministry of Health announced guidelines (April 1) related to leveraging compliance with the EU legislation. The provisions of Regulation 2023/607 are entirely endorsed by the Medical Device Division (AMAR). 

In Australia, the TGA published guidance (updated January 2024) that explains the conditions of their acceptance of MDD Certificates that remain valid under the provisions of Regulation 2023/607. Additional evidence of eligibility for extended validity must be submitted along with the application.

Concluding remarks

As the May 26 deadline approaches, regulators who leverage compliance with the MDR have now also articulated how these changes will be managed. For the most part, most have accepted the EU dates, other than the MHRA who modified the end of December 2028 date to the end of June 2028.