Med-tech: AI Products Face More EU Regulations
May 24, 2021
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by Arabella Seebaluck

Med-tech regulation is a developing field in EU
The European Union is planning on introducing more regulations on artificial intelligence med-tech. The proposed legal framework will look at regulating the technology to meet the bloc’s standards. Non-compliance will result in fee ranging to billions of dollars.

A new policy will be introduced for the use of Artificial Intelligence in med-tech. In the proposal, the European Commission has stated that high-risk AI systems which ‘comply with certain mandatory requirements’ are the only ones which will be available in the European Union market.

In the long list of products which could be tagged as high risk are medical devices and in-vitro diagnostics. Companies which are found to be defaulters can face fines of up to 6% of their revenue. 

What is Med-tech?
Medical Technology includes medical devices, in-vitro diagnostics, information technology, biotech, and healthcare services. Artificial Intelligence is a growing field in med-tech and the European Commission’s report emphasising on regulations on AI states: ‘To promote the development of AI and address the potential high risks it poses to safety and fundamental rights equally, the Commission is presenting both a proposal for a regulatory framework on AI and a revised coordinated plan on AI.’

European Union and the Med-tech industry
These recently proposed changes are in line with European Union’s policies towards med-tech. The Union’s executive arm, the European Commission, had proposed creating an online database to strengthen market surveillance and transparency for medical devices in the European market, called Eudamed. The proposal was made in 2011. Eudamed is expected to be ready by May 2022.

In 2020, MedTech Europe launched a study to assess the impact of AI in healthcare. The study covered 8 AI application categories including wearables, real-world data, virtual health assistance, personalised apps and robotics. Essentially tools which can be used for a patient’s full diagnosis and recovery. 

MedTech Europe commissioned Deloitte Belgium to conduct the study. The study concluded that to unlock the full potential of AI in healthcare, European health systems will have to focus on the evaluation of these technologies, workforce skills and training and data interoperability and ownership/

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