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Cybersecurity In The EU: How Overlapping Regulations Could Harm Medtech

 
• By Eliza Slawther

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.

Cybersecurity
• Source: Shutterstock

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...

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