Explore European Union Legislation by Asking a Legal Question
assisted-checkbox
filter-instruction-1
positive-filters
negative-filters
act-filter tabs-all
parameters-title
query
assisted-checkbox: ✅
result-title
total 1
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. ) article 34 CELEX: 02017R0745-20250110 Functionality of Eudamed
1. The Commission shall, in collaboration with the MDCG, draw up the functional specifications for Eudamed. The Commission shall draw up a plan for the implementation of those specifications by 26 May 2018. 2. The Commission shall inform the MDCG when, on the basis of independent audit reports, it has verified that one or more of the electronic systems referred to in Article 33(2) are functional and meet the functional specifications drawn up pursuant to paragraph 1 of this Article. 3. The Commission shall, after consultation with the MDCG and when it is satisfied that the conditions referred to in paragraph 2 have been fulfilled, publish a notice to that effect in the Official Journal of the European Union. |