It's finally here. The European Commission's new In Vitro Diagnostic Regulation (IVDR 2017/746) will address several weaknesses of the IVDD and bring significant regulatory changes for IVD manufacturers selling in Europe. The IVDR will apply from 26 May 2022, but proactive IVD companies are planning their implementation strategies now.
In this white paper, Emergo takes an in-depth look at the IVDR and answers your biggest questions about Europe's changing regulatory landscape. You will learn:
- Implementation timelines
- Scope of the Regulation
- List of new concepts
- Detailed description of changes, by chapter
- also included: Classification Quick Reference Guide
Learn all this and more in this 15-page white paper.
About the Author
Ronald Boumans, MsC is Senior Regulatory Consultant at Emergo's office in The Hague. He previously served as Inspector of Medical Technology at the Dutch Healthcare Inspectorate (IGZ), and his areas of expertise include European medical device legislation, Competent Authority supervision, and CE Marking requirements.