Updated: New EU Templates For IVD Performance Study Sponsors, Including For Substantial Modifications
Executive Summary
With the official launch of Eudamed still some 18 months aways, the EU has published a series of templates to help sponsors of IVD performance studies communicate with member state authorities. This piece has now been updated to reflect the availability of a new template for substantial modifications of a performance study.
You may also be interested in...
European Commission Expects Eudamed To Be Fully Ready By Q2 2024
The European Commission has published an updated timeline for delivering the EU medical device database. Regarded as the cornerstone of the EU medical device and IVD regulations, the Eudamed database will have been delayed by four years and there are transition periods ahead.
BSI Notified Body Highlights Crucial Elements Related To EU’s MDR Amending Regulation
BSI Group has issued a useful Q&A document on how it sees the new EU MDR amending Regulation, which extends the transition deadlines for legacy medical devices, impacting manufacturers and their relationship with notified bodies.
European Commission Proposes First “Master UDI-DI” - For Contact Lenses
Medtech stakeholders are being invited to comment on a proposed delegated regulation, the type of which could eventually be relevant for more than just contact lenses.