View source for Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble Preamble

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{{:Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble}}

{| class="wikitable gplx-infobox"
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Module
| Module 1 — Unit 1.3.0
|-
! Scope
| IVD
|-
! Document part
| Preamble
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
| 
|-
! Tags
| [[Glossary:TAG-00231-Per-ung|Performance study]], [[Glossary:TAG-00043-Goo-tek|Good clinical practice]], [[Glossary:TAG-00218-Har-päi|Harmonised standard]], [[Glossary:TAG-00220-Inv-agn|IVD]]
|-
! Comment
| Performance study rules aligned with international standards
|}

== Content ==
EU Regulation 2017/746 – Preamble:
(66) The rules on performance studies should be in line with well-established international guidance in this field, such as the international standard ISO 20916 on good clinical practice for clinical investigations of medical devices for human subjects […]

In addition, the rules should be in line with the most recent version of the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects.