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.
Pragmatic solutions are called for to ensure that German medical device manufacturing and innovation remain competitive in global terms, federal health minister Nina Warken told a hearing of medtech industry leaders.
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?
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.
The UK Medicines and Healthcare products Regulatory Agency said its RegulatoryConnect program “no longer offers value for money for UK taxpayers” and will be closed just 19 months after its April 2024 launch.
Inaugural cabinet office dialog session leaves German medtech optimistic about increasing central government support in the coming months, say trade associations in Medica preview.
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.
The prosthetics market is evolving due to an increase in amputees from war and disease. Unhindr has developed a novel prostetic liner that can reduce the risk of further injury, while Esper is crafting advanced hand implants for Ukraine's front-line soldiers.
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.
The EU’s Medical Device and IVD Regulations require every manufacturer and authorized representative to have a PRRC. As compliance becomes mandatory for increasing numbers of manufacturers, figures are soaring and this role is becoming both increasingly distinctive and more complex.
Fines are a fact of life when it comes to manufacturers’ compliance with EU rules on persons responsible for regulatory compliance. But Italy’s stance adds pressure on individuals appointed to the role.
The first-of-its-kind sandbox for insights on how to regulate artificial intelligence in healthcare has accepted seven more AI innovators onto its learning program.
With a new EU medtech regulatory proposal soon to be released, how far will wider EU initiatives that have been less widely discussed impact the regulations and the anticipated new governance structure? Medtech Insight spoke with Erik Vollebregt in Rome.
John Nugent, who heads the medtech division at Irish business development agency IDA Ireland, spoke to Medtech Insight about how the country’s 75-year focus on encouraging medtech innovation is shifting in the light of digital health, AI, tariffs, and other new challenges.
An EU-funded project is supporting Ukraine in replacing its fragmented regulatory system with a new, centralized State Control Authority for medicines and medical devices, aligned with best EU practices.