The latest list includes a new EU document in the wings that addresses the designation of medtech notified bodies under the AI Act.
The European Commission’s Medical Device Coordination Group has started work on a document clarifying the designation process of notified bodies according to the AI Act (Regulation (EU) 2024/1689).
The text, which is being worked on by the MDCG’s Notified Bodies Oversight subgroup, is due to be endorsed by...
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.
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.
MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”
The UK government’s blueprint to deliver an NHS "fit for the future" was released on July 3.
