MDS REQ 1 Requirements for Medical Devices Marketing ...

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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)

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

  General, Annex