In recent news, the European Commission proposed an extension to the transition deadline for Legacy Medical Devices to be placed on the EU market. Here is a quick summary of recently posted information about the reasoning behind this decision and how it affects Medical Device Manufacturers.
Currently Legacy Medical Devices, i.e., devices with a valid Medical Device Directive (MDD) or an Active Implantable Medical Device Directive (AIMDD) certificate and without any significant design changes, are able to be placed on the market under Medical Device Regulation (MDR) Article 120(3) until May 26, 2024. Two surveys conducted in 2022 confirmed the low number of designated Notified Bodies (now 36) are not expected to complete the necessary MDR assessments by the May 26, 2024 deadline, resulting in a shortage of medical devices on the EU market.
In response, on December 9, 2022, the European Commission (EC) proposed and the European Council expressed agreement to a PROPOSAL to extend the transition period for Legacy Medical Devices to be placed on the market. Legacy Medical Devices, i.e., devices with a valid Medical Device Directive (MDD) or an Active Implantable Medical Device Directive (AIMDD) and without any significant design changes, are able to be placed on the market under MDR Article 120(3) until May 26, 2024.
The published proposal includes the following provisions:
- Extend the Legacy Device Class III and IIb transition period end date to place products on the market to 2027 [May-26] [extended 3 years]
- Extend the Legacy Device Class IIa and I (NB Conformity Assessment required, i.e., Class I Sterile, Measuring Function, and Reusable Surgical Instrument) transition period end date to place products on the market to 2028 [May-26] (extended 4 years)
- Extend the validity of Legacy MDD and AIMDD certificates [MDR Article 120(2)]
Limit the extension only to Legacy Devices that:
- Do not present any unacceptable risk to health and safety
- Have not undergone significant changes in design or intended purpose
- For which the manufacturers have already undertaken the necessary steps to launch the certification process under the MDR
- Remove the one-year “Sell-off” period for Legacy MD (and IVD) devices to flow through the supply chain.
The Council indicated the EC proposal will be addressed in January 2023. A MDR amendment is expected to define the Legacy Medical Device transition extension.
Proposed EU MDR/IVDR Timeline
IMPORTANT - There is no mention in the proposal to change the mandatory UDI/Device Registration period to EUDAMED. As provided by the MDR, this period is triggered by the EC Notice that “EUDAMED is fully functional.” The mandatory EU UDI/Device Registration period is currently expected to be from Q4 2024 to Q2 2026.
This proposal only addresses Legacy Medical Devices. Legacy In-Vitro Diagnostic devices were previously granted a 1-year transition extension and extended dates for up-classified IVDs. Although some have indicated the low IVDR NB capacity and slow migration to IVDRs may need to be re-evaluated.
On the same day, December 9, 2022, the Medical Device Coordination Group (MDCG) released a guidance document MDCG 2022-18 that indicated how Legacy Devices with expired MDD/AIMD certificates and MDD/AIMD certificates expiring before May 26, 2024 could remain on the market for a “reasonable” period to time after their certificate expired.
This provision does not include a significant number of Legacy Devices that have MDD/AIMDD certificates expiring after May 26, 2024 – so it is not a comprehensive solution. The MDCG guidance refers to Article 97 MDR where Competent Authorities in EU Member States are able to address non-compliant devices where “certification of devices under the MDR has not been finalized before expiry of the Directive’s certificate, and where the device does not present an unacceptable risk to health and safety.” The CA may define a reasonable period of time (generally 12 months) within which the manufacturer has to bring the device into compliance with the MDR. The recommended steps and qualifying conditions are detailed in the MDCG document.
In all cases, manufacturers will need to register currently marketed products, either Legacy Devices or MDR Equivalent Devices and any new MDR Devices, during the mandatory registration period (and spontaneously upon a serious incident report).
As more information comes in, we will continue to report on this evolving process. For additional information about EUDAMED and other Medical Device resources, please visit our Knowledge Center.
Questions about health authorities and Unique Device Identification (UDI)? We monitor health authorities around the globe for the latest requirements and exceptions. If you have UDI questions, we can help. Email us: [email protected] or call +1-215-557-3010