Medical Device

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.

An interactive look at recent executive-level company changes and promotions in the biopharma, medical device and diagnostics industries.

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

In an ongoing effort to accelerate the commercialization of select innovative drugs and medical devices, Korea’s MFDS is launching a new program for certain products that will receive regular regulatory consultations until they reach the approval stage.

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.

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.

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.

Lawmaking in Germany came to a halt after the federal election was called, meaning cardiovascular detection and pharmacy legislation were put on hold. In part one of a two-part interview on key themes for industry, Martin Walger, chief executive of the IVDs industry association, the VDGH, lays out the hopes and fears of IVD companies in the run up to the late February vote.

The new definition of what is considered an ‘AI system’ in the context of the EU’s AI Act is helpful, but there is no automatic determination for medtech, and gray areas persist.