Page Last Updated: 20 March 2023
Medical Device legacy devices are:
On 20 March 2023, the MDR’s transitional provisions were extended. The transition period was originally set to end 26 May 2024. However, Regulation 2023/607 has now extended the transition period to the following:
*The following devices are excluded and are eligible for the 31 December 2028 deadline: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors
While not technically categorized as a legacy device, Class III implantable custom-made devices have been granted a further transition period to obtain conformity assessment certification from a Notified Body. These products may be lawfully placed onto the market without a conformity assessment certificate until 26 May 2026, provided that they: 1) lodged a formal application with a notified body no later than 26 May 2024 and 2) have signed a written agreement with a Notified Body no later than 26 September 2024.
IVD legacy devices are:
IVD legacy devices may continue to be placed onto the European Single Market after the IVDR’s date of application (26 May 2022), through the following dates:
IVDR, Article 110 (2 and 3) outlines which devices are eligible for the transition period.
The self-declared/self-certified device must have already had MDD/IVDD CE Marking on the MDR/IVDR’s date of application to be considered a legacy device.
Where a manufacturer places a new device onto the market, i.e., one that did not yet have CE Marking by the MDR/IVDR date of application, then that device is not eligible for this transition period allowance. Meaning:
Additional Conditions: Medical Devices and IVDs
The following conditions apply to all legacy devices (Notified Body CE Marked and Self-Declared):
Additional Conditions: Medical Devices Only
Where these requirements are met:
MDD Class I self-certified legacy devices may continue to be placed onto the EU market until 31 December 2028.
IVDD self-certified legacy devices may continue to be placed onto the EU market based on the timelines provided in the above IVD section.
If a manufacturer intends to make a significant change to the design or intended purpose of the device, then the manufacturer should work with a Notified Body toward MDR/IVDR CE marking.
MDR/IVDR sections related to post-market surveillance, market surveillance, vigilance and registration of economic operators and devices apply to all legacy devices. As well, the quality system requirements will become applicable for MDD/AIMDD devices starting 26 May 2024.
The MDCG has published guidance to help clarify the requirements: MDCG 2021-25 for medical devices and MDCG 2022-8 for IVDs.
The following are examples extracted from the MDCG annexes and Regulation 2023/607, which amends the transitional provision of the MDR.
MDR/IVDR Section | Applicable: YES/NO |
---|---|
MDR Art. 10(10), (12)-(15)/IVDR Art. 10(9), (11)-(14) – General obligations of manufacturers, specifically the sections related to post-market surveillance, market surveillance, vigilance and registration of economic operators and devices | MDR – “YES (nota bene: ‘conformity with the requirements of this Regulation’ shall mean for ‘legacy devices’ conformity with the MDD or AIMDD and the additional requirements in accordance with Article 120(3) MDR)” IVDR – “YES (nota bene: ‘conformity with the requirements of this Regulation’ for ‘IVD legacy devices’ means conformity with the IVDD and the additional requirements in accordance with Article 110(3) IVDR)” |
MDR Art. 10(9) on quality system requirements | “YES” – Per EU Regulation 2023/607, which amends the MDR’s transitional provisions, medical device manufacturers must implement a quality management system as outlined in MDR Article 10(9) no later than 26 May 2024 |
MDR/IVDR Art. 13(2) 2nd subparagraph, (4), (6)-(8), (10)- General obligations of importers, specifically the sections related to post-market surveillance, market surveillance, vigilance and registration of economic operators and devices | MDR – “YES (nota bene: ‘conformity with the requirements of this Regulation’ shall mean for ‘legacy devices’ conformity with the MDD or AIMDD and the additional requirements in accordance with Article 120(3) MDR)” IVDR – “YES (nota bene: ‘conformity with the requirements of this Regulation’ for ‘IVD legacy devices’ means conformity with the IVDD and the additional requirements in accordance with Article 110(3) IVDR)” |
MDR/IVDR Art. 15 – Person Responsible for Regulatory Compliance | “NO” |
MDR Art. 27/IVDR Art. 24 – Unique Device Identification (UDI) system | Device Identification (UDI) system “NO (See in this respect also MDCG 2019-5 on registration of legacy devices in Eudamed)” |
MDR Art. 32/IVDR Art. 29 – Summary of safety and clinical performance/Summary of safety and performance | “NO” |
MDR Art. 85/IVDR Art. 80 – Post-market surveillance (PMS) report | MDR – “YES (classification of devices in class I follows classification rules of the MDD, i.e. Art. 85 applies to class I ‘legacy devices’ despite the fact that those devices might be in a higher class under the MDR)” IVDR – “YES, applicable to all ‘legacy devices’, unless manufacturer voluntarily prepares a PSUR pursuant to Article 81” |
The Medical Device Coordination Group (MDCG) has released guidance documents related to ‘significant’ changes.
MDD/AIMDD Legacy Devices – MDCG 2020-3
The guidance document provides feedback such as: “administrative changes of organisations are considered in principle as nonsignificant. This includes changes of the manufacturer’s name, address or legal form (legal entity remains) or changes of the authorised representative.”
It additionally provides a series of flowcharts to help manufacturers assess if a change may be considered significant.
IVDD Legacy Devices – MDCG 2022-6
Like the guidance for medical devices, the IVD legacy guidance document provides feedback and flowcharts of what may be considered a significant change.
For more information, please read: MDCG Guidance on IVDR Legacy Device Transition and Significant Changes