AI Act – What are the challenges for Medical Devices?

You are working with a Software that contains an AI/ML algorithm then you should listen to this podcast episode and understand the requirements of the AI ACT to your medical device. Fabien Roy, lawyer will explain to us what are the challenges that he has identified for medical device manufacturers working with Artificial Intelligence.

Who is Fabien Roy?

I am an EU pharma/device lawyer and problem solver. My practice focuses on European Union (EU) and national regulatory matters involving medical devices and pharmaceutical laws and guidelines. I am following very closely the new regulations on medical devices (MDR and IVDR), the GDPR and regularly advise clients in relation to the requirements applicable to their digital health technologies. I focus particularly on the different stages of the medical device CE marking process and advise on a wide variety of topics which include the following:

• – determination of the appropriate classification of individual products;
• – clinical investigation procedure (e.g. authorisation from the EU Member States competent authorities, opinion from Ethics Committee, amendment to the Protocol, informed consent, serious adverse event qualification and notification, handling of personal data);
• – drafting of clinical investigation and clinical trial agreements, distribution agreements and contract manufacturing agreements;
• -clinical data requirements and clinical evaluation;
• – conformity assessment procedure;
• – review of Instruction For Use, products’ labelling and promotional material including websites;
• – post-marketing surveillance activities including the notification of adverse event, product recall or product withdrawal;
• – preparation and review of technical documentation;
• – reimbursement. I also advise on questions regarding marketing authorisation procedures, variation procedures, and clinical trials, promotional and marketing activities in the pharmaceutical sector. Specialties: Regulation of medical devices and medicinal products in the EU
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Who is Monir El Azzouzi?

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device field pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 

Link:

• Fabien Roy Linkedin Profile: https://www.linkedin.com/in/fabien-roy-83b55021/
• Company Website:   https://www.hoganlovells.com/
• Ai Act text: https://www.europarl.europa.eu/doceo/document/TA-9-2024-0138_EN.pdf

Social Media to follow

• Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
• Twitter: https://twitter.com/elazzouzim
• Pinterest: https://www.pinterest.com/easymedicaldevice
• Instagram: https://www.instagram.com/easymedicaldevice

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