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.
Cybersecurity In The EU: How Overlapping Regulations Could Harm Medtech
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.
