Artificial Intelligence in Medical Device Legislation

We're pleased to inform you about the in-depth analysis we have conducted at COCIR with regard to Artificial Intelligence in EU Medical Device Legislation. Analysing all aspects of the conformity assessment process and how they would apply to AI-based medical devices with different characteristics, this analysis aims to show how AI can be deployed in a way that is consistent with existing Regulations.

Next to that we would also like to make you aware that we are periodically updating the list of AI Use cases provided by our member organisations which demonstrate how AI is already being used in the healthcare setting:

We hope these documents can contribute to an informed debate on how to build trustworthy AI and how sector-specific approaches may help addressing the legal and ethical issues in a targeted way.



COCIR is the European Trade Association representing the medical imaging, radiotherapy, health ICT and electromedical industries.

Founded in 1959, COCIR is a non-profit association headquartered in Brussels (Belgium) with a China Desk based in Beijing since 2007. COCIR is unique as it brings together the healthcare, IT and telecommunications


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Submitted by Juan LLORET on Sat, 05/09/2020 - 09:27

Thanks for share it. Good job, sure, regarding some start point:


"The European Commission has shown its ambition in the area of artificial intelligence (AI) in its recent White Paper on Artificial Intelligence – a European approach to excellence and trust1 . This White Paper is at the same time a precursor of possible legislation of AI in products and services in the European Union. However, COCIR sees no need for novel regulatory frameworks for AI-based devices in Healthcare, because the requirements of EU MDR and EU IVDR in combination with GDPR are adequate to ensure that same excellence and trust (Chapter 5 & 6)".


In reply to by Juan LLORET

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Submitted by Juan LLORET on Sun, 06/09/2020 - 14:10


After a first sensible and comparative reading with other international literature, I consider that this document is an extensive, careful and very good technical guide to use as a reference in the use of Artificial Intelligence in medical devices.

The approaches it carries out, based on using existing regulations in the EU (EU MDR and EU IVDR) are highly structured, profitable and carefully technically explicitly and implicitly. It is highly recommended to read these 40 pages, which will place those responsible for the design, development and marketing of medical devices very close to reality in my opinion.

COCIR presents us with a huge effort and a great international vision as well. In my opinion. I have been impressed by its professionalism, its writing and the commitment with which it has been made.

  1. I propose to the people affected in the EU regarding the field of artificial intelligence that this work be read and highly considered by the people who assume that responsibility. 
  2. And I request with humility and good faith (without personal interests) that this document occupies a place priority on the agendas of experts in the field of Artificial Intelligence and  /or security.

Thank you for your work and your time.

Best regards, Juan Antonio Lloret

Ps: Congratulations on the job. I will personally use it in IEEE forums and show it as a guide to follow regarding development to another standars to take in account this.

In reply to by Juan LLORET

Submitted by Danny Van Roijen on Mon, 07/09/2020 - 10:21

Dear Juan,

many thanks for your positive response and kind consideration.




In reply to by Danny Van Roijen

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Submitted by Juan LLORET on Tue, 08/09/2020 - 13:06

Your are wellcome,  Danny. Hopefully everything goes well.

Regards, Juan Antonio Lloret.