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In-vitro Diagnostic Regulation | MakroCare

In-vitro Diagnostic Regulation | MakroCare

Submitted by • May 14, 2020 www.makrocare.com

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.

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