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Beyond MDR: How Stricter EU Rules On AI And Data Are Set To Impact Medtech

 
• By Eliza Slawther

The second half of 2022 has seen much debate and concern from EU medtech stakeholders around numerous proposed horizontal rules that will affect digital products. Changes in policies around AI, cybersecurity and data-sharing are likely to be an even bigger theme in 2023.

EU Lock
• Source: Shutterstock

The European Commission’s ambitions to increase the safety of products available in the EU has been a key driver of the Medical Device and IVD Regulations (MDR/IVDR), but this is not the only area where tougher regulations have proven troublesome for medtech.

Indeed, its proposed Artificial Intelligence (AI) Act has met with much criticism from the medical device community and beyond. Trade association MedTech Europe has warned that the new rules, if or when adopted, will clash with sector-specific regulations in the MDR and create even more workload for manufacturers

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