MDCG 2021-1: Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional

The European Commission has just published the Guidance MDCG 2021-1. This document intends to describe harmonized administrative practices and alternative technical solutions for the exchange of information until EUDAMED becomes fully functional.

The aim is to enable the different actors to meet their obligations with the requirements of Regulation (EU) 2017/745, including those relating to the provisions referred to in Article 123(3) (d) and (e), while minimizing any potential additional burden.

In principle and unless otherwise concluded by the MDCG, the reporting obligations in EUDAMED apply to all information generated and collected under the Regulation (EU) 2017/745 from its date of application (e.g. UDI, certificates) and therefore must be carried out as soon as EUDAMED becomes fully operational.

As a reminder, since December 1^st, 2020, on a voluntary basis, the economic operators concerned can register in EUDAMED for the issuance of the SRN (Single Registration Number) by the national competent authority.

DOWNLOAD THE GUIDANCE MDCG 2021-1