It is important that all manufacturers who still need to apply for conformity assessment of their high-risk class D devices in the context of the IVD Regulation encounter improvements in the efficiency and predictability path to certification.
But, at present, manufacturers wishing to transition their class D IVDs to the IVDR “face numerous challenges.”
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?