Regulation
Are you selling a high-risk AI-enabled device or service? Understanding the next steps is crucial. A team of legal experts has shared valuable advice to help you start to understand the complexities.
China's medical equipment industry is growing rapidly, driven by limited domestic presence in high-cost segments and increasing adoption of local products in areas like monitoring equipment, defibrillators, and ventilators. International giants dominate the high-end market, but domestic companies such as Neusoft Medical Systems and Mindray Medical are making significant strides.
Lawrence Tallon will succeed June Raine as MHRA chief executive on 1 April. UK medtechs will prioritize an early meeting with the man who since 2020 has served as deputy chief executive of Guy’s and St Thomas' NHS Trust.
In the wake of a series of unprecedented executive orders from US President Trump, the EU medtech industry faces significant political, regulatory and business challenges. Swift and strategic action is essential to ensure stability and safeguard patient safety.
EU industry advocates for amendment to existing proposal to streamline clinical strategy costs and timelines, as well as boost efficiency and innovation
A new memo from the Office of Management and Budget directs federal agencies to create plans for reorganization and staff reductions to improve efficiency. While the document includes an exemption for staff working on public safety issues, it’s unclear whether that will be enough to keep FDA reviewers and inspectors on the job.
Assimilated EU medtech law used in Great Britain will not be sunsetted on 26 May 2025, as originally provided for. That was the first decision published by the MHRA in the wake of its recent consultation on shaping the regulatory system.
As the EU AI Act takes shape, critical details are emerging rapidly. However, the approaching deadlines are even more pressing. This article delves into the essential information that medtech professionals need to stay ahead.
The Irish notified body has had to suspend IVD client work since late 2024.
Industry and healthcare professionals generally welcome the European Commission's proposal to broaden the use of eIFUs. However, more official statements are still awaited.
A lead reviewer at the US FDA’s device center is back on the job after being caught up in the purge that hit the agency over Presidents Day weekend. Before learning that his termination had been rescinded, he told Medtech Insight he was indebted to the US for the opportunities the country had given to him.
Some US FDA employees who were recently laid off by the Trump Administration, including in CDRH, are being called back to work, multiple sources confirmed to MTI's sister publication, the Pink Sheet.
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.