UK’s NHS Launches AI Regulation Service Specifically For Medtech Firms
The regulatory landscape for digital and AI-based products can be tough for companies and users alike to navigate. Four UK organizations have partnered up to create a service that aims to demystify complex regulatory rules around AI and digital medtech.
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Stack Of New And Revised EU MDR and IVDR Guidances In The Pipeline
The EU has published a lengthy list of new guidances to be drafted as well as existing guidance documents that need updating in the context of its MDR and IVD medtech regulations, including covering the interpretation of the Medical Device Regulation wording on “significant changes.”
France Latest Country To Introduce Digital Medtech Reimbursement Fast-Track
France has introduced a fast-track market access pathway for certain digital health products, adding to similar schemes in neighboring EU countries Germany and Belgium. But how does the new reimbursement program work, and which products are eligible for coverage?
MHRA Says UK Approach To AI Regulation ‘Legislatively Light’, Unlike EU Proposals
The UK’s medtech regulator is “going big on guidance” when it comes to artificial intelligence and software as a medical device, an expert from the agency has said, while legislation will be light in comparison to the EU’s planned AI Act.