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  1. Introduction

   1. Introduction.srt

   1.2 REGULATION (EU) 2017745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices.html

  2. Harmonised standards for medical devices

   1. Harmonised standards for medical devices.srt

   1.2 Commission Implementing Decision (EU) 20211182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017745 of the European Parliament

   1.4 MDCG 2021-5 Guidance on standardisation for medical devices April 2021.html

  3. CHAPTER I General Requirements (SaMD)

   1. Chapter I General Requirements SaMD.srt

   1.2 EN 301 549 V3.2.1 (2021-03) Accessibility requirements for ICT products and services.html

   1.4 MDCG 2019-16 - Guidance on Cybersecurity for medical devices.html

   1.6 MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies.html

   1.8 MHRA Medical device stand-alone software including apps.html

  4. CHAPTER II, Requirements Regarding Design and Manufacture (SaMD)

   1. CHAPTER II, Requirements Regarding Design and Manufacture (SaMD).srt

  5. CHAPTER III of General Safety and Performance requirements (SaMD)

   1. CHAPTER III, Requirements Regarding the Information Supplied with the.srt

   1.2 MDCG 2018-5 UDI Assignment to Medical Device Software.html

  6. Final Notes

   1. Final Notes.srt