MDR & IVDR: Guidelines for MedTech Hardware and Software
Developing medical technology is challenging enough, but turning a brilliant idea into a compliant, market‑ready medical device is a whole different playing field. Holland Innovative, PCV Group and Evidencio take you from regulation and methodology, through product development in practice, from hardware to software, data, and market access. Expect a morning filled with practical examples and clear explanations of MDR, IVDR, CE‑marking, and the latest update-proposal, all directly applicable to your own medical device development.
Who is this event for?
Entrepreneurs, startups and scale‑ups in MedTech, QA/compliance engineers, software and hardware developers, researchers, and other professionals working on medical devices.
Practical information
- Date: Tuesday, 12 May
- Time: 9:00 – 13:00 (including lunch)
- Location: TechMed Centre, Auditorium | University of Twente
- Language: Dutch
- Sign up here
Program
09:20 – 10:10 | MDR & IVDR: the essentials (Holland Innovative) Lisette van Steinvoren and Lisanne Karbaat (Holland Innovative) open with a real case that brings MDR and IVDR to life. They walk through the essentials: CE‑marking, defining a medical device, the importance of intended use, and how software fits into the regulatory framework. They also clarify the key differences between MDR and IVDR and translate the latest 2026 EU proposal into practical takeaways for developers and manufacturers.
10:20 – 11:10 | MDR & hardware in practice (PCV Group) Lili-Marjan Boelens and Joris Bronkhorst (PCV Group) show what MDR looks like once you leave the theory behind. Using concrete development cases, they highlight the challenges teams face when designing medical devices, and the practical tools that help products meet (and maintain) compliance in day‑to‑day development.
11:20 – 12:10 | Software as a medical device, data‑driven systems, and market access (Evidencio) Tom Hueting (Evidencio) explains when MDR, IVDR and the AI Act apply to software and data-driven technologies. Through clear examples, he shows how intended use drives classification, what requirements shape market access, and what ongoing compliance really looks like. He also shares lessons from Evidencio’s own certification journey.
Partners
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