Several times per week we solve this particular problem. The diagnosis đ: The first user registering a company often does not have suffi...
Transition to the new âEU REPâ 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 đĄ
Numerous misunderstandings exist around EUDAMED. We are happy to share and clarify them for you! Exemptions and further aspects may apply...
MDSSâ EUDAMED Updates!
EUDAMED playground: MDSSâ 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 regulationâs clear wording, uncertainty remains widespread across the industry, with differing interpretations and expectations between ...
EUDAMED Milestone Reached â What It Means for Manufacturers and their processes with MDSS
đ¨ Today marks the first official EUDAMED deadline, reinforcing a critical shift. EUDAMED registration is now mandatory for new devices enter...
ReminderâNew 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. â  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...
Annex IX 2.4 – A logical approach
When does a change become âsubstantialâ under the MDR/IVDRâand when must your Notified Body be informed? MDSS is seeing a rising number of quest...
