MDCG 2020-3 Rev. 1: Guidance on significant changes to transitional provisions under Article 120 MDR revised
31 May 2023
Medical devices placed on the market after the effective date of the Medical Device Regulation (EU) 2017/745 (MDR), 26 May 2021, and compliant with MDCG Guidance 2021-25 are considered “legacy devices“. These include:
- “devices which are class I devices under Directive 93/42/EEC (MDD), for which an EC declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure under the MDR requires the involvement of a notified body;
- devices covered by a valid EC certificate issued in accordance with Directive 90/385/EEC (AIMDD) or the MDD prior to 26 May 2021.”
If the devices continue to comply with the requirements of the AIMDD or MDD, they may be placed on the market or put into service until 31 December 2027 or 31 December 2028, respectively, in accordance with Article 120(3) of the MDR, as last amended by Regulation (EU) 2023/607.
Article 120(3c) of the MDR provides, among others, that legacy products must continue to comply with the AIMDD/MDD and that there are no significant changes in the design or intended purpose of the device. The MDCG 2023-3 “Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD” serves to explain the concept of “significant changes in the design and intended purpose.”
“The first revision of the guidance document MDCG 2020-3 on significant changes regarding the transitional provisions under Article 120(3) MDR takes into account the experience gained with the application of the original version so far, is aligned with the equivalent guidance for IVDs, MDCG 2022-6 of May 2022 and adjusted to Regulation (EU) 2023/607.”