Health Tech Regulation
Tue, Sep 01
|Online + Rigshospitalet
What You Need to Know Before You Build
Time & Location
Sep 01, 2026, 3:00 PM – 5:00 PM
Online + Rigshospitalet, Blegdamsvej 60B, 2100 København, Opgang 94 A, 1. sal, Cafeen
About the event
Health Tech Regulation
What You Need to Know Before You Build
Session Description
Most health tech products intended for professional healthcare require regulatory approval - a process that is costly, complex, and often underestimated.
Based on insights and learnings from 100+ health tech start-ups, this workshop explores when regulation may be avoided, how to start your MDR journey, and what timelines and resources to expect.
We will cover common pitfalls, regulatory strategy, and how early decisions impact speed, cost, and overall feasibility. The session concludes with a short demo and introduction to Health Tech Pathways, a Novo Nordisk Foundation-supported tool designed to guide teams through EU MDR.