Regulation

MedTech Europe’s Petra Zoellner discusses industry's response to EU regulatory proposals aimed at improving notified body operations, transparency, and cost predictability, ultimately fostering innovation in medical technology.

In this second of a three-part series, Medtech Insight spoke with three neuroethicists who raised concerns about privacy, patient safeguards and the need for comprehensive guidelines. These issues are becoming more pressing as BCI companies get ready to commercialize their products.

The US FDA has made incorporating real-world evidence into medical device decisions a lot easier. The agency now says it will accept RWE without requiring it to contain identifiable individual patient data, making more of it available. Many stakeholders welcomed the change.

Joint Singapore-UK plan underlines direction of travel for MHRA after its embracing of international reliance (IR). Australia’s TGA has also broken new ground by recognizing the UKCA mark.

Industry associations support the commission’s MDR/IVDR revision simplification objective and aim to increase Europe’s competitiveness, but MedTech Europe also sees further room for improvement.

As requested by a pair of US senators, the GAO has published a report on how the FDA handles medical device recalls. The review found that the agency lacks the necessary staff and regulatory authority to process recalls safely and effectively.

The just published proposed targeted revision of the Medical Device and IVD Regulations is a radical rethink of how the EU should regulate medical devices. The document is aimed at supporting industry and patients alike.

Roadmap version 1.0 is a living document, not a legislative instrument, that will be updated and tweaked for timings as necessary.

New document sets out a structured framework to help breakthrough medical devices tackling serious health needs navigate EU regulation with greater clarity, collaboration and predictability.

Rapid advancements in neurotechnology intensify the need for clear regulations concerning neural data privacy. As these technologies evolve at unprecedented speeds, lawmakers, legal experts, and neuroethicists are increasingly focused on their societal impact.

Just ahead of the European Commission publishing its proposed revisions of the Medical Device and IVD Regulations, it has released an equally important document on the future of notified body operations in the bloc.

The US FDA’s General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee convened Wednesday to discuss germicidal ultraviolet (GUV) devices as a mode of disinfection, a technology that has emerged since the COVID-19 pandemic.

A new face seconded to the European Commission's medtech unit and changes to several EU rules impacting medtech

Sponsors of higher risk device and diagnostic investigations are being invited to participate in a pilot that aims to reduce regulatory burden.

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