Cybersecurity in the EU

Industry has been worried for some time about convergent EU regulations concerning medical devices and cybersecurity. Trade associations like MedTech Europe believe that horizontal legislation, such as the Artificial Intelligence (AI) Act proposals, could overlap with Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices (MDR and IVDR), resulting in regulatory fragmentation and uncertainty among medical device manufacturers. 

In addition, other legislation, such as the EU Directive on Security of Network and Information Systems (NIS Directive) and its proposed revised form, NIS2 could oblige manufacturers to duplicate certain duties.

The situation is highly dynamic and manufacturers and associated entities are well-advised to have a close eye on the corresponding developments.

Source: Medtech Insight (an Informa product)

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