EU level guidance has been issued on custom-made devices (CMDs), adaptable medical devices and patient-matched medical devices. It should help clarify how to regulate devices which lie on the borderline between needing to fully comply with the EU's MDR and those that eligible for some regulatory exemptions as CMDs.
An eight-page Q&A document, endorsed by the European Commission’s Medical Device Coordination Group, helps clarify the nuanced differences between CMDs, adaptable medical devices and patient-matched medical devices and the necessary regulatory approaches according to their precise definition.
The text also examines the area of overlap between materials used in both CMDs and medical devices that undergo the...
June Raine was a “hard act to follow” at MHRA, but new chief executive Lawrence Tallon is looking to the future in setting out a vision for the UK regulator.
The US Department of Commerce’s investigation into the national security impact of importing various medical equipment could lead to tariffs on many products. Device industry responds by emphasizing the robustness of domestic production, but also the rigidity of supply and reimbursement agreements.
Industry survey points to ongoing low revenues rise and weaker profit levels for half of BVMed industry association members in 2025, as German manufacturers raise stakes on global harmonization.
A pioneering initiative, Edvance MedTech, is being launched by leading experts in medical technology regulation which aims get to the heart of what is needed to improve the way EU rules are not only applied but also decided.
Some of the first manufacturers to receive Medicare coverage for their breakthrough devices through the Transitional Coverage for Emerging Technologies pathway praise CMS’ engagement and timelines in the process, despite some challenges around post-launch data collection.
Industry survey points to ongoing low revenues rise and weaker profit levels for half of BVMed industry association members in 2025, as German manufacturers raise stakes on global harmonization.
A pioneering initiative, Edvance MedTech, is being launched by leading experts in medical technology regulation which aims get to the heart of what is needed to improve the way EU rules are not only applied but also decided.
