The AI Act is due for publication in July 2024. Marco Caproni of notified body, TÜV SÜD, explained how requirements over and above those in the MDR and IVDR impact medtech manufacturers.
The AI Act, the first of its kind in the world, will need to be fully enforced for products that come under the scope of both the Medical Device Regulation or In Vitro Diagnostics Regulation and the AI Act within three years of its publication in the Official Journal of the EU i.e. likely July/August 2027.
There are still many unknowns. The AI Office is now operational and work is beginning on filling in the details....
A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.
Thena Capital, the first UK-based early-stage specialist medtech firm, has made its first investment since closing its £50m fund. Medtech Insight spoke with general partner Pamela Walker Geddes to gain insight into Thena Capital’s investment strategy.
Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it.
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.
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.
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