Updated: EU IVD Regulation Guidance On Significant Changes Now Available
Executive Summary
With just a few weeks to go until the IVD Regulation fully applies, much-needed guidance has been published which discusses “significant changes” for legacy IVDs
You may also be interested in...
EU Explains Steps Sponsors Must Take When Using Companion Diagnostics In Drug Development
A new Q&A document from the European Medicines Agency outlines the key steps that pharma companies should take when using companion diagnostics in clinical trials, and the information it expects to see in marketing authorization applications.
Second EU MDR Notified Body Designated In France
Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has been named too.
EU Regulatory Experts Support Notified Bodies, But Argue For Greater Consistency
Notified bodies have been a pivotal part of the EU medtech regulatory system since it was first launched in the 1990s. Where might they fit within a new medtech regulatory governance structure? Panelists on a recent vodcast grappled with the question.