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Full text of EU MDR (Medical Device Regulation)

EU MDR Table of Contents

Chapter 1 (Art. 1 – 4)
Scope and definitions
Chapter 2 (Art. 5 – 24)
Making available on the market and putting into service of devices, obligations of economic operators, reprocessing, CE marking, free movement
Chapter 3 (Art. 25 – 34)
Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European database on medical devices
Chapter 4 (Art. 35 – 50)
Notified bodies
Chapter 5 (Art. 51 – 60)
Classification and conformity assessment

Section 1 (Art. 51)
Classification
Section 2 (Art. 52 – 60)
Conformity assessment

Chapter 6 (Art. 61 – 82)
Clinical evaluation and clinical investigations
Chapter 7 (Art. 83 – 100)
Post-market surveillance, vigilance and market surveillance

Section 1 (Art. 83 – 86)
Post-market surveillance
Section 2 (Art. 87 – 92)
Vigilance
Section 3 (Art. 93 – 100)
Market surveillance

Chapter 8 (Art. 101 – 108)
Cooperation between member states, medical device coordination group, expert laboratories, expert panels and device registers
Chapter 9 (Art. 109 – 113)
Confidentiality, data protection, funding and penalties
Chapter 10 (Art. 114 – 123)
Final provisions
(Anx. 1 – 17)
Annexes

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:

‘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).’.

« Article 117 – Amendment to Directive 2001/83...Article 119 – Amendment to Regulation (EC) N... »

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