Device was placed on the market only until the date of application of the MDR(26 May 2021) or the IVDR (26 May 2022).
• No registration in the UDI/DEV module is possible.
Sources: MDCG 2021-25 Rev.1 (MD), MDCG 2022-8 (IVD)
Special case
• Registration required in the event of a vigilance case via the EUDAMED Vigilance module (once operational).
(A device which was declared in conformity with Directive 90/385/EEC (AIMDD),Directive 93/42/EEC (MDD) or Directive 98/79/EC (IVDD) and subsequently placed on the market pursuant to Article 120(3) MDR (after 26 May 2021) or Article 110(3) IVDR (after 26 May 2022).)
No additional registration required.
Sources: Article 123(3)(e)(ii) MDR, Article 113(3)(fa)(ii) IVDR
Registration required no later than 28 November 2026.
Sources: Article 120(3d) MDR, Article 123(3)(e)(ii) MDR, MDCG 2021-25 Rev.1, Article 110(3d) IVDR, Article 113(3)(fa)(ii) IVDR, MDCG 2022-8
No explicit registration obligation.
Further note:
• The MDR / IVDR requirements relating to post-market surveillance, market surveillance and vigilance also apply to LEGACY DEVICES.
Sources: Article 120(3d) MDR, MDCG 2021-25 Rev.1, Article 110(3d) IVDR, MDCG 2022-8
Registration required immediately (prior to placing on the market).
Sources: Article 29 MDR, Article 26 IVDR
Sources: Article 123(3)(e)(i) MDR, Article 113(3)(fa)(i) IVDR
• However, the MDR/IVDR requirements relating to post-market surveillance, market surveillance and vigilance must still be complied with.
Sources: Article 123(3)(e)(i) MDR, Article 120(3d) MDR, Article 113(3)(fa)(i) IVDR, Article 110(3d) IVDR, MDCG 2022-8
Version dated 2026-06-18
Disclaimer:
The conclusions presented are based on the legislation available at the time of preparation, in particular the consolidated versions of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), as well as the relevant publications of the European Commission and the Medical Device Coordination Group (MDCG). The regulatory framework is subject to continuous development. In addition to the legally binding legislation, numerous guidance documents, position papers, question-and-answer documents and other publications issued by European institutions and expert bodies exist, some of which address or interpret specific issues differently. Furthermore, future legislative changes, new guidance documents or further clarifications issued by the competent authorities may lead to different conclusions on individual matters. Accordingly, this decision tree does not claim to provide an exhaustive or generally binding legal interpretation. Rather, it is intended as a practical guide based on the information currently available. We recommend that you continuously monitor developments in the relevant legislation, MDCG documents, Commission publications and EUDAMED-related guidelines, and regularly assess the implications for your products, registrations and processes. Where necessary, this may require you to take additional measures or adapt existing registration strategies.
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