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Dynamic EU MDR 2017/745 Full Text
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
Chapter 6 (Art. 61 – 82) Clinical evaluation and clinical investigations
Chapter 7 (Art. 83 – 100) Post-market surveillance, vigilance and 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
Annexes
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Dynamic EU MDR 2017/745 Full Text

Now you can navigate the full text of the
EU Medical Device Regulation 2017/745
⁠
with ease.
The Regulation has been transcribed here and is divided by Chapter and Article in the left hand navigation pane. References to other Articles or Directives within the main text have turned into hyperlinks which you can click directly. The search bar can also be used to search for keywords in the Regulation.
Some Articles have additional Regulatory Intelligence™ built into the full text, as indicated by the icons below:
⏳ Orignial MDR text has been updated by later legislation or amendments. Updated text is shown in bold, with links provided as footnotes.
🎁 Further Guidance is available for this topic, with links provided
💡 Plain langauge summaries and examples to help explain certain MDR requirements



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