Transcription of MDS REQ 1 Requirements for Medical Devices Marketing ...
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MDS REQ 1 Requirements for Medical Devices Marketing ...
MDS-REQ-001-V6/211219 Page 1 of 109 MDS REQ 1 Requirements for Medical Devices Marketing Authorization Version Number: Version Date: 19/12/2021 MDS-REQ-001-V6/211219 Page 2 of 109 Table of Content Introduction _____ 3 Purpose _____ 3 Scope _____ 3 Background _____ 3 Requirements _____ 4 Annexes _____ 6 annex (1) Essential Principles of Safety and Performance for Medical Devices other than In-Vitro Medical Device _____ 7 annex (2): Essential Principles of Safety and Performance for In-Vitro Medical Devices 29 annex (3) Medical Device Technical Documentation _____ 50 annex (4) IVD Technical Documentation _____ 59 annex (5) Risk Classification Rules for Medical Devices _____ 69 annex (6) Clinical Evaluation and Post-Market Clinical Follow-Up _____ 81 annex (7): Performance Evaluation, Performance Studies and Post-Market Performance Follow-Up _____ 84 annex (8) Implant Card and Information t
Annex (5), the general safety requirements set out in Essential Principle (1) and Essential Principle (8) shall be understood to mean that the device, when used under the conditions and for the purposes intended, does not present a risk at all or presents a risk that is no more
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