Work is progressing towards publications of an updated list of standards to support implementation of the EU’s new medtech regulations.
The revised EU mandate for standards that are required in the context of the Medical Device and IVD Regulations is currently under official review. The commission hopes it will be published in early 2023.
This will be the first amendment to the European Commission mandate for the development of harmonized medtech standards. The original...
The Milner Institute, the on-campus hub for start-up acceleration at Cambridge University, hosted its annual Pitch Day on July 1. Start-ups Panakeia, PathwayBio and Sentinal4D presented diagnostic technologies.
To succeed in medtech, investors must focus on patient outcomes. Gilde Healthcare says involving patients boosts product effectiveness, access and market success — making it a smart strategy in today’s strained healthcare systems.
Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.
