Overlapping EU regulations that relate to medical devices and cybersecurity have been a concern among industry for many months. Medtech Insight asks an expert where, how and why overlap could prove troublesome.
Trade bodies have already warned that horizontal legislation, such as the Artificial Intelligence (AI) Act proposals, could overlap with the EU Medical Device and IVD Regulations (MDR/IVDR), leading to regulatory fragmentation and confusion among medical device manufacturers.
This is not the only piece of EU legislation that could catch device makers out, however. Elisabetta Biasin, an expert...
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.
Advocates spanning the spectrum of women’s health met in Manhattan to discuss the gender disparities that remain in healthcare and how public policy can correct them and the enormous ROI investors in women’s health can potentially reap.
The US FDA issued eight warning letters in September and October, with ultrasound, surgical and mobile apps among the affected product types.
