On 29 June 2026, Switzerland issued a declaration under the Joint Statement on a Framework for a United States-Switzerland-Liechtenstein Agre...
EU Publishes Delegated Acts on Well-Established Technologies (WET)
The European Commission has published two delegated acts on Well-Established Technologies (WET) under the Medical Devices Regulation (EU) 20...
EU AI Act Update — More Time, Same Expectations
The European Parliament has approved a major adjustment to the AI Act timeline, voting overwhelmingly to adopt a Digital Omnibus package design...
You want to start EUDAMED registrations – but can’t⁉️
Several times per week we solve this particular problem. The diagnosis 🔍: The first user registering a company often does not have suffi...
Transition to the new “EU REP” Symbol!
The European regulatory landscape for medical devices continues to evolve. A key recent development is the formal transition from the long-esta...
EUDAMED advice for free! We bust EUDAMED myths 💡
Numerous misunderstandings exist around EUDAMED. We are happy to share and clarify them for you! Exemptions and further aspects may apply...
MDSS’ EUDAMED Updates!
EUDAMED playground: MDSS’ SRN is DE-AR-000030861 The EUDAMED playground is a useful tool for testing and training EUDAMED registration...
Selling into the EU? Understanding Packaging and EPR Obligations Under PPWR
The EU Packaging and Packaging Waste Regulation (PPWR) will become applicable on 12 August 2026 and will replace the current Packaging and Pack...
🚨 Key Deadline Approaching: MHRA Annual Fee (30 June 2026)
Stay ahead and keep your UK market access uninterrupted — the MHRA Annual Fee deadline for April 2026 – March 2027 is fast approaching! &n...
📢 Pre market medical devices regulation – stakeholder impact survey
The Medicines and Healthcare products Regulatory Agency has an Open call for evidence on proposed changes to pre-market regulatory requireme...
