5 mai 2017 In order for manufacturers to be able to demonstrate the conformity of such products the. Commission should adopt common specifications at ...
15 févr. 2021 MDR EUDAMED. 1. EUROPEAN COMMISSION – DG SANTE. 1 INTRODUCTION ... Regulation (EU) 2017/745 (MDR) or Regulation 2017/746 (IVDR).
4 juil. 2022 Article 42(13) MDR. Article 38(13) IVDR. Commission Implementing Regulation (EU) 2017/2185. Definition of the list of codes and ...
24 nov. 2017 Having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices amending Directive ...
26 mai 2021 EUROPEAN COMMISSION. DIRECTORATE-GENERAL FOR HEALTH ... medical devices through a specific chapter of the EU-Switzerland Mutual Recognition.
5 mai 2017 (21) Directive 98/79/EC allows the Commission to adopt common technical specifications for specific categories of in vitro diagnostic medical ...
20 août 2020 Article 42(13) MDR. Article 38(13) IVDR. Commission Implementing Regulation (EU) 2017/2185. Definition of the list of codes and ...
European Commission - Research Directorate-General. Directorate L - Science Economy and Society. Unit L3 - Governance and Ethics. Page 1 of 7.
Medical Devices (Eudamed) as required by Article 27(3) of MDR and Article 24(3) of IVDR. UDI issuing entities designated by the European Commission.
17 déc. 2015 THE EUROPEAN COMMISSION. Having regard to the Treaty on the Functioning of the European Union