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Q&A on MDR and IVDR Implementation by Guillaume is a document available to read on EtoBox.

What is Q&A on MDR and IVDR Implementation about?

This document provides guidance on implementing the new Medical Device Regulations and In Vitro Diagnostic Medical Device Regulations. It addresses several topics: 1) Medical devices that are an integral part of a medicinal product are subject to additional requirements under Article 117, including providing an EU certificate from a notified body. 2) Medicinal products that include a medical device in secondary packaging are also discussed. 3) The consultation procedure for medical devices incorporatin

Author

Guillaume

Language

EN