Date: 2 October, 2026
Location: DEKRA Certification, Meander 105, 6825 MJ Arnhem, the Netherlands
Introduction:
In recent months, the European Commission has put forward several proposals to amend legislation affecting stakeholders across the medical device and in vitro diagnostics sectors. Understanding their potential impact is essential to preparing for what comes next.
The RAPS Netherlands Chapter’s 43rd meeting brings together authorities, Notified Bodies, manufacturers and legal experts to explore MDR 2.0, IVDR 2.0 and the Digital Omnibus. Through panel discussions and parallel sessions, participants will examine the proposals and their practical implications for manufacturers and hospitals.
Qserve's Gert Bos, RAPS Netherlands Chapter board member, will attend and moderate the Digital Omnibus parallel session, featuring manufacturer and legal perspectives.
Agenda
| Time | Session |
|---|---|
| 09:30–10:00 | Arrival and welcome |
| 10:00–10:30 | Chapter opening and DEKRA introduction |
| 10:30–10:45 | Programme introduction; proposal process, timelines and transitions |
| 10:45–11:45 | Panel: Annex VII and proposed changes—status, impact, communication and governance |
| 11:45–12:30 | Panel: Implications for existing and future products |
| 12:30–13:00 | Audience questions |
| 13:00–14:00 | Lunch |
| 14:00–14:45 | Parallel sessions, round 1: MDR 2.0, IVDR 2.0 and Digital Omnibus |
| 14:55–15:40 | Parallel sessions, round 2 |
| 15:45–16:15 | Tea break |
| 16:15–17:00 | Session conclusions and closing panel with Notified Bodies and authorities |
| 17:00–17:05 | Closing remarks |
| 17:05–18:00 | Networking drinks |
Bring your questions, exchange perspectives and connect with regulatory peers. For more details, and the full agenda, visit the event website.
DEKRA Certification, Arnhem, the Netherlands
02 October 2026