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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 researcher who has published academic papers on EU cybersecurity legislation...

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