In Vitro Diagnostics

This brings the total number of notified bodies appointed under the IVDR to 14

As the EU seeks to refine its medtech regulations, the advantages of the global Medical Device Single Audit Program are increasingly highlighted. Industry leaders are now urging authorities to take decisive action.

The latest list includes a new EU document in the wings that addresses the designation of medtech notified bodies under the AI Act.

Improving reimbursement and integrating digital process across health care should be two priorities for the incoming German coalition, says Martin Walger, chief executive of the IVD industry association, the VDGH, in part two of his interview with In Vivo.

During Q4, biopharmas brought in an aggregate $16.8bn in financing and device company fundraising totaled $2.3bn; while in vitro diagnostic firms and research tools players raised $294m.

The European Commission has launched a pilot to deliver on its promise that member states should coordinate with each other on clinical assessment reviews under the Medical Device and IVD Regulations.

Industry is quoting the Draghi report on EU competitiveness and its call for a clear, agile and streamlined legal framework in an attempt to get the EU to prevent overkill in the regulation of AI.

Good is not always good enough. A centralized oversight body could help EU medtech testing bodies reach their full potential and ensure consistent regulatory balance says life sciences expert lawyer, Alison Dennis.

New data-sharing framework signals a new era for health data exchange as EU initiatives to maximize its benefits kick into action.

EU study underscores need for reform in predictability, transparency, and cost-efficiency to enhance Europe’s competitiveness and strengthen its global role in health care.