Quiz:
MDR and AI Act for healthcare organisation

Available upon request

Laws and regulations do not have to be boring! With this interactive quiz, the audience gets to understand the most important aspects of the European legislation around AI in healthcare, ensuring the responsible use in clinical practice.

About the quiz

What should you definitely check when you buy an AI solution? Do patients have to be informed about the use of AI? Is the use of autonomous clinical AI now illegal? What about use of in-house developed AI, should you comply to the AI -Act as well? Should generative AI tools have a CE-mark?

There are several European laws and regulations in place that apply to AI in healthcare. The most important ones are the MDR and AI -Act and they have very practical implications. It is not just important for legal specialists to know about this, but also for users, purchasers, IT specialists and managers. Having a basic understanding ensures the right decisions are made in the adoption process, minimizing risk and ensuring safety of the patients.

We know that this topic does not make everybody's heart beat faster, that is why we have turned it into a fun, interactive quiz with easy to understand explanations in between so all participants can join!

Practical details

  • 15-60 minutes
  • Medium to large audiences
  • Language: English, Dutch (other languages upon request)
  • On-site or online

Contact us to discuss pricing

Who is this for?

Healthcare Professionals & AI Users

Staff who work with AI in daily practice and want to know their responsibilities, such as human oversight and informing patients, so they can use AI tools safely and with confidence.

Management & Procurement

Decision-makers and buyers who choose and purchase AI solutions, and need to know what to check, from CE marking to vendor obligations, to minimise risk for their organisation and patients.

IT & Legal

Professionals who implement, maintain or assess AI systems, and need a clear overview of which regulations apply and what they mean in practice for in-house and purchased AI.

All Staff Members

Anyone in the organisation who comes into contact with AI and wants an accessible, engaging introduction to the MDR and AI Act, with no prior legal knowledge needed.

What you will learn

The regulatory landscape

  • Understand why European legislation such as the MDR and the AI Act exists, and what it aims to protect
  • Recognise when an AI solution qualifies as a medical device and requires a CE mark
  • Determine which regulation applies to a given AI solution: the MDR, the AI Act, or both

CE marking and your obligations

  • Explain what a CE mark does and does not guarantee, and what to verify when purchasing an AI solution
  • Name the key obligations for deployers, including AI literacy, human oversight, logging, input data quality and transparency towards users and patients

Applying it in practice

  • Recognise the implications of in-house developed AI and of general-purpose and generative AI
  • Apply this understanding when selecting, purchasing, developing, implementing or using AI in your own organisation

Our trainers

The workshop is led by the Romion Health team

Julian Stijf

AI Coach Intern

Alexandra Castillo Paucar

Digital Marketing Intern

Cristina González Gonzalo

Consultant Artificial Intelligence

Khrystyna Faryna

Collaborating researcher, Health AI Register Pathology

Joske van der Zande

Collaborating researcher, Health AI Register Cardiovascular

Nico Frijns

AI consultant

Marlie Besouw

Collaborating researcher, Health AI Register Radiotherapy

Matina Laskou

Business Development & Marketing Coordinator

Sade Krijgsman

Consultant Artificial Intelligence

Karel Hehenkamp

Content Manager Health AI Register

Kristyn van der Veen

Consultant AI Literacy Programmes

Daan Geijs

Lead developer

Stephan Romeijn

Managing Partner

Kicky van Leeuwen

Managing Partner

Interested in this workshop?

Want to make the MDR and AI Act accessible for everyone in your organisation? Let’s discuss how this quiz can fit your event, team meeting or training day, on-site or online. We’ll tailor the questions to your context.

Get in touch with us