The European Commission has published two delegated acts on Well-Established Technologies (WET) under the Medical Devices Regulation (EU) 20...
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...
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...
Online Seminar: Substantial Changes – Annex IX 2.4
Despite the regulation’s clear wording, uncertainty remains widespread across the industry, with differing interpretations and expectations between ...
EUDAMED Milestone Reached – What It Means for Manufacturers and their processes with MDSS
🚨 Today marks the first official EUDAMED deadline, reinforcing a critical shift. EUDAMED registration is now mandatory for new devices enter...
Reminder❗New MIR form – mandatory from 1st May 2026
MIR form v7.3.1 (update 23 April 2026) becomes mandatory for serious incident reporting under MDR & IVDR. ✅ Action needed today: Con...
Breakthrough medical devices: information session
In December 2025 the Medical Device Coordination Group (MDCG) published a guidance introducing the EU Breakthrough Devices framework, supportin...
