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).

Sources: MDCG 2021-25 Rev.1 (MD), MDCG 2022-8 (IVD)

(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.

Sources: Article 123(3)(e)(ii) MDR, Article 113(3)(fa)(ii) IVDR

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

Registration required no later than 28 November 2026.

Sources: Article 123(3)(e)(i) MDR, Article 113(3)(fa)(i) IVDR

No explicit registration obligation.

• 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