European healthtech compliance insights
Practical analysis of the regulations, standards and security requirements affecting healthtech, medical software, AI and health-data companies across Europe. Every article distinguishes confirmed obligations from transition periods, market expectations and developing rules.
Latest analysis
Cybersecurity
Cyberbeveiligingswet from 15 August 2026: a practical NIS2 guide for healthtech suppliers
What the Dutch Cyberbeveiligingswet means for healthtech suppliers from 15 August 2026: scope, NEN 7510, incidents and hospital procurement.
11 July 2026
NEN 7510 & Dutch Healthcare
NEN 7510:2024 transition guide: what healthtech organisations must finish before 20 February 2027
How to transition from NEN 7510:2017+A1:2020 to NEN 7510-1:2024 before 20 February 2027, including A1:2026, audit readiness and supplier scope.
6 July 2026
EU Product Security
CRA or MDR? Which cybersecurity regime applies to your health software
Does your health software fall under the CRA, MDR or IVDR? A practical European healthtech guide with product examples and 2026-2027 deadlines.
16 July 2026