Regulation

Pending legislation in the US House of Representatives would allow Medicare patients to benefit from some of the latest and most innovative technologies. The bipartisan bill would establish a clear pathway for reimbursement for algorithm-based healthcare services approved by the FDA.

The MHRA’s premarket statutory instrument for Great Britain should to be laid before UK parliament in Q2 and be in force by year end, in an ideal world. There are concerns that the new statutory instrument must align with imminent EU MDR changes.

With the roll out of agentic AI, the US FDA continues to expand AI capabilities across the agency. The latest AI deployment follows the agency’s May launch of Elsa, its generative AI tool, which marked ‘the dawn of the AI era’ at the FDA.

In September, the US FDA asked the public to weigh in on how AI-enabled medical devices perform in real-world settings. With the comment period now closed, the agency has heard back from dozens of stakeholders on how the agency can use clinical outcomes to better understand these devices.

Simultaneous revisions of the EU’s AI, data and medtech rules offer opportunities for simplification and alignment but also risk confusion and competing priorities. With political tensions in the background, does all this portend further unwanted compromises or delays for medtech?

After years of delays - and even skepticism in Rome last month when officials hinted at its imminent debut - the long-awaited EUDAMED medical device database release has finally been confirmed

The European Commission’s Digital Omnibus Package promises to simplify EU complex digital compliance processes, but is it taking the EU in the right direction in its simplification efforts?

Abbott has initiated a medical device correction for about 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the US after internal testing detected a risk the device may produce inaccurate glucose readings.

A recent study demonstrates that certain types of blood-based tests that screen for multiple cancers at once have the potential to flip the script on cancer diagnoses, including some of the deadliest types.

The European Commission seems to have heeded many of the medtech industry’s points regarding challenges with the implementation of the AI Act within the Digital Omnibus. But the usual EU hurdles must be crossed before the sector will know if these proposals will make it into law.

Medtech companies should not look at the current period as a regulatory hiatus, but as an opportunity to avoid a crisis two to three years down the line.

The association’s recent position paper highlights how complex the transfer process is but explains to manufacturers and notified bodies how to meet the requirements.

Brain-computer interfaces advance toward trials and commercialization, Oura pushes for FDA-cleared blood pressure monitoring, and regulators weigh AI’s expanding role in mental health and diagnostics amid rising safety concerns.

The US FDA has issued a draft guidance document to help device manufacturers navigate the new Quality Management System Regulation (QMSR) concerning premarket approval applications and humanitarian device exemptions applications. The new regs take effect in February.

UK SMEs complained about the proposed 2025-2027 MHRA user fees and got easements on payments for trials and scaled-back registration and PMS service fees. Now the agency is offering more assistance in a pilot of clinical trial fee waivers.

The sector has been waiting long enough for one of the foundation stones of the implementation of the EU’s Medical Device and IVD Regulations. This month will see a landmark event.

While anticipation grows around the European Commission’s forthcoming medtech proposal, due in mid-December, a series of EU documents have been published on topics including recertification, standards, changes to companion diagnostics and the latest notified body announcements.

During the MDIC Excellence in Quality Summit, an expert in product recalls offered several unconventional and somewhat controversial factors that impact how quickly device makers initiate a recall once they discover a problem.

FDA advisers gave a cautious nod to the idea of using generative AI in mental healthcare during a Nov. 6 panel meeting, saying evidence-backed tools could help expand access – but warning that safety, oversight, and the irreplaceable human connection remain major unanswered questions.

The roles and responsibilities of EU medtech’s persons responsible for regulatory compliance vary widely in role and risk exposure. The recent TEAM-PRRC meeting highlighted how vulnerable they can be and the steps to protect themselves.