On 29 June 2026, Switzerland issued a declaration under the Joint Statement on a Framework for a United States-Switzerland-Liechtenstein Agre...
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The role of the Importer under the MDR/IVDR — Myths, Misconceptions, and Real Obligations
This session addresses common myths regarding the Importer role under the MDR/IVDR, clarifying the regulatory requirements applicable to Importers and...
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...
Team-NB Position Paper on the Transfer of IVDR Formal Applications and Surveillance of Legacy Devices
On 10 June 2026, the European Association of Medical Devices Notified Bodies (Team-NB) adopted a new Position Paper entitled: “Agreement Related...
