|Products Concerned||MD, IVD|
|Regulatory reference||MDR (EU) 2017/745
Article 123(3) d) and e)
Annex VI, part A section 2
Annex VI, part B
IVDR (EU) 2017/746
Article 113 (3) a) et f)
Annexe VI, partie A section 2
Annexe VI, partie B
The purpose of this document is to clarify the date of application of certain registrations in EUDAMED, where there are some inconsistencies in the MD Regulation.
Thus, the MDCG specifies that the registration of device information (Annex VI, Part A, Section 2) and the registration of the elements to be provided in the UDI database (Annex VI, Part B), will apply 18 months after the date of application of the Regulation (i.e. 26 November 2022) or, if EUDAMED is not fully functional in time, from 24 months after the date of publication of the Commission’s notice.
The MDCG also specifies that the date of application of assignment of Basic UDI-DI and UDI-DI remains applicable on the date of application of the Regulation, 26 May 2021.
These considerations apply mutatis mutandis to the IVDR.