Medical devices

Standalone software may qualify as a medical device. This may apply to an application or SaaS service, for example. Artificial intelligence (AI) can be part of a medical device.

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Support from Legal ICT

Software is a medical device if the manufacturer (which may be developer) has developed the software specifically for use in a human being with a medical purpose. Examples of a medical purpose are diagnosis and treatment. All medical devices must have a CE mark, which certifies that the product meets the legal safety and quality requirements.

We are happy to support you in applying these laws and regulations in your practice.

Our support can include advising on how to comply with laws and regulations, drawing up or reviewing documents, handling negotiations and providing continuous remote or on-site support.



We have experience in providing legal advice and training to healthcare providers, ICT service providers, sector organisations and government bodies on various matters, including:

  • How online services qualify in legal terms. For example, determining whether the online service qualifies as an electronic exchange system, a care information system, a medical device or an information society service.
  • Classification of a medical device in a particular risk class. The risk class of a product determines who awards the CE mark.
  • Outsourcing to or providing IaaS, PaaS or SaaS services used in healthcare.
  • Drawing up documents for the purchase or provision of online services and the standard conditions often applied for this, i.e. the General Purchase Conditions in Healthcare (AIVG), the General Purchase Conditions of the Dutch Federation of University Medical Centres (NFU), the general terms and conditions drawn up by NLdigital (formerly Netherlands ICT) and/or the data processing agreement drawn up by the Sector Organisations in Healthcare (BoZ).
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Our legal advisors

Meet our legal advisors. They will be happy to assist your organisation with practical advice:

Would you like to learn more?

For more information, call +32 (0)2 808 17 41. You can also leave a message using the form; one of our trainers will then contact you.

When you enquire about our services, we will always first arrange a non-binding introductory meeting by phone, at our office or at your premises.

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