Skip to Content

in-vitro diagnostic regulation | MakroCare

in-vitro diagnostic regulation | MakroCare

Submitted by • May 14, 2020

The EU In Vitro Diagnostic Regulation (IVDR) implementation debates starting ahead of the GAP assessments. MakroCare Experts guide you how to go about doing a systematic review of your technical documentation and QMS.Currently, only 10-20% of IVDs are subject to Notified Body scrutiny under the IVDD. That number will increase to 80-90% under the IVDR (In Vitro Diagnostic Regulation) and increase the limited number of Notified Bodies authorized to do IVD product reviews.

Voted by:
Voted by priya melie

<a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <s> <strike> <strong>