Full text of EU MDR (Medical Device Regulation)
[simple-social-share css="0"]

EU MDR Table of Contents

Source EUR-Lex: https://eur-lex.europa.eu/
EU MDR Chapter 10 Article 118

Article 118 – Amendment to Regulation (EC) No 178/2002

In the third paragraph of Article 2 of Regulation (EC) No 178/2002, the following point is added:

  1. ‘i)medical devices within the meaning of Regulation (EU) 2017/745 of the European Parliament and of the Council (*).
(*) 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 (OJ L 117, 5.5.2017, p. 1).’.
IMPLEMENT ISO 13485 & MDR
BY YOURSELF

SEE HOW IT WORKS

  • Optimized for small and medium-sized companies
  • Costs up to 80% less than using consultants
  • Expert consultations and unlimited email support available
  • Created by Advisera, the leading website for compliance