Can I read IVDR Transitional Provisions Guidance on EtoBox?
IVDR Transitional Provisions Guidance by eli is a document available to read on EtoBox.
What is IVDR Transitional Provisions Guidance about?
This document provides guidance for notified bodies and manufacturers on appropriate surveillance of medical devices during the transitional period from the IVDD to the IVDR. It outlines that notified bodies must continue surveillance of devices covered by existing IVDD certificates to ensure ongoing compliance with IVDD requirements. Notified bodies must also verify that manufacturers have adjusted their quality management systems to comply with specified post-market and vigilance requirements in the IVDR.
- Author
- eli
- Language
- EN