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The AI Act needs to go hand in hand with sectoral legislation to keep AI-enabled products on the EU market

Posted on 30.09.2022

Brussels, 30 September 2022 In a joint statement, industry stakeholders call for the alignment of the proposed AI Act with sector-specific product safety legislation. If issues of overregulation and misalignment are not addressed, the resulting regulatory uncertainty could adversely impact the access of European citizens to safe and high-quality goods ranging from medical technologies, machinery and tools used in the automotive and furniture sector to gardening tools and machines protecting against electric fires.  

The proposed Artificial Intelligence Act (AI Act) builds on the legal architecture of the New Legislative Framework (NLF) that serves to improve the safety and quality of products accessing the European market.  

Stakeholders representing, among others, the machinery and medical technology industry point out in a joint statement released today that the proposal in its current form, however, significantly risks overregulating industries. If not addressed adequately, the duplicative requirements it creates could limit a wide range of products and technologies to access the EU market. 

In the case of medical technologies, this could have a significant impact on manufacturers that are already under significant regulatory strain.  

Meeting the requirements of our own sectoral regulation under the NLF has required heavy lifting from the medical technology industry, but also for the Notified Bodies, where we currently see the biggest bottleneck. The impact of additional requirements from the AI Act would have manufacturers facing further technical and financial burdens as well as capacity constraints to get devices certified for the European market. We need to avoid this regulatory fragmentation, which could adversely impact patients’ access to innovative healthcare solutions“, said MedTech Europe CEO Serge Bernasconi. 

The statement’s signatories support the NLF provisions as a means of complying with the AI Act. However, when shaping and negotiating the AI Act, EU legislators should ensure that the requirements set out in this regulation will align closely with existing obligations in sector-specific legislation. 

MedTech Europe, together with the other industry stakeholders, are committed to continuing constructive dialogues on this issue with legislators to help build a proportionate and well-functioning regulatory system that enables a trustworthy AI regulatory framework and seamless access of safe and high-quality products to the European market. 

About MedTech Europe

MedTech Europe is the European trade association for the medical technology industry including diagnostics, medical devices and digital health. Our members are national, European and multinational companies as well as a network of national medical technology associations who research, develop, manufacture, distribute and supply health-related technologies, services and solutions.

For more information, please contact:

Caroline Moulins
Sr. Manager Communications External Affairs
MedTech Europe
[email protected]