In Vitro Diagnostics

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?

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.

How will medtech be buffeted by what is seen as the EU’s capitulation to US demands to water down its AI and data regulations?

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 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.

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.