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EU plans to enforce additional regulations on MedTech AI products, other 'high-risk' systems.


AI and SaMD are the future of MedTech development. In these times, such stringent regulations could be seen to hamper the industry's capacity to innovate.


In a document setting out its plans, the European Commission emphasised advancing regulations for MedTech AI products. Already the EU MDR has brought in significant change for medical devices; this additional statement could hold back innovation. This proposal document emphasised the need for public involvement.


The proposed regulation states that the AI MedTech product can only be placed on the EU Market "if they comply with certain mandatory requirements" to ensure that they do not pose unacceptable risks to the patient or other key users in healthcare.


It could be seen that these additional requirements will have a global influence negatively impacting the innovative development of medical devices and diagnostics. To support this proposed new regulation, the European Commission also plans to levy significant fines of up to €30 million ($36 million) to non-compliant companies.  If the offender is a multinational, however, then the fine will be 6% of its total worldwide annual turnover for infringement of the requirements. 


It is clear the Commission has acknowledged the fact that there could be overlap between regulations as they state that the existing conformity assessment procedure would be utilised in managing and checking the "proposed AI requirements."


Our Experts at Med-Di-Dia believe that it’s important to harmonise the requirements for AI so as to provide a level playing field for companies innovating in this space and to avoid any misinterpretation of requirements. Above all, this harmonisation will help to ensure AI is designed and tested to a high standard thereby mitigating, or even eradicating, any risk of causing harm to the patient or the user.   Don’t forget that the incoming medical device and in-vitro diagnostic regulations have come about because of ‘scandals’ in the sector - PIP implants, metal on metal hip replacements, Theranos blood test.  With the rapid rise of AI, it’s critical that there is consistency in the approach to its development and its use in healthcare so as to avoid any future scandals.  In this instance, we definitely do not want ‘history to repeat itself!


Let our experts guide you smoothly through the medical device regulatory process. We provide a wide range of services and offer Free Consultation.

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