Regulation
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.
A flurry of firings as part of the Trump administration’s pledge to shrink the federal government hit the FDA over the weekend. While the exact number of staff let go is unclear, the agency’s device center took the brunt of it.
The latest list includes a new EU document in the wings that addresses the designation of medtech notified bodies under the AI Act.
A federal judge granted Doctors for America’s motion for a temporary restraining order directing the FDA and CDC to restore information removed from the agencies’ websites to comply with a presidential executive order targeting “gender ideology extremism.”
Notified bodies’ conformity assessment processes can easily be streamlined and made potentially less costly within the context of the EU’s current regulations.
The MHRA’s post-market surveillance regulations for Great Britain will be followed in 2026 by a pre-market regulation, but its progress will not be steered by the agency’s erstwhile leader of device system transformation. The ABHI’s Steve Lee and Phil Brown ponder where national device system regulation – and the MHRA – go next.
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.
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.
The US Food and Drug Administration (FDA) draft guidance limits tissue biopsy collection in clinical trials to primary endpoints and specific research use cases. However, Andrew Newland, CEO of circulating tumor cell (CTC) liquid biopsy firm Angle Plc, believes that the guidance could enhance the market for liquid biopsy makers.
Measures for reporting interruption of supply or discontinuation of devices in Europe were rushed into the Medical Device Regulation, a German law firm claims, leading to the need for a stricter interpretation.
The Dermanostic app is in the spotlight again as its recent action has prompted a German regional court to believe it no longer falls foul of a ruling recently made by a higher regional court.
The US FDA says diabetes patients who rely on their smartphones to receive critical disease-related alerts should ensure their phones are configured correctly. If not, the alerts might be missed.
Agencies within the US Department of Health and Human Services are beginning to communicate with the public again as HHS lifts the pause for some types of notices. However, other delays persist.
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.
Cardiovascular detection and pharmacy legislation were put on hold last November when Germany's federal election was called. Martin Walger, chief executive of the IVDs industry association, the VDGH, discusses the hopes and fears of IVD companies in the run-up to the February 2025 vote.
An innovative patient monitoring system developed by Danish physicians sends vital signs data directly to nurses, allowing them to keep tabs on patients without being in the room.
Seven new Centers of Excellence for Regulatory Science and Innovation have been funded by the UK with a brief to investigate smart regulation of AI and digital health innovations, among other areas. Medtech Insight asked Alastair Denniston, leader of the CERSI in AI and Digital Health Technologies, to explain the significance and the goals of his center.
While the main deadline for the application of the EU’s AI Act to most AI-enabled medical technologies already regulated under the medtech regulations is 2 August 2027, various more immediate deadlines also need meeting.
Sara Brenner has been a key figure in the FDA’s diagnostics team, but her choice as acting FDA commissioner likely has more to do with her background with advanced technology and comfort level with the tech-focused side of the Trump transition team.