Regulation (EU) 2017/746
id:
regulation-eu-2017-746-264-2043904
title:
Regulation (EU) 2017/746
text:
Regulation (EU) 2017/746 (IVDR) is a regulation of the European Union on the placing on the market and putting into service of in vitro diagnostic medical devices (IVD), repealing Directive 98/79/EC (IVDD), which also concerned IVD. The regulation was published in April 2017 and is closely aligned to the EU regulation on medical devices.
Changes compared to the IVDD include changes in device classification, stricter oversight of manufacturers by Notified Bodies, introduction of the "Person Respo
brand slug:
wiki
category slug:
encyclopedia
description:
original url:
https://en.wikipedia.org/wiki/Regulation_(EU)_2017/746
date created:
date modified:
2023-04-11T06:41:27Z
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image:
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fields total:
13
integrity:
14