Team NB MDR Clinical Requirements Training (27 August 2025): Deadline for SME Reduced Fee Ends Today
Team Notified Body (NB) scheduled a ½ day training session on MDR clinical requirements for Wednesday, August 27, 2025. It […]
10 events found.
Events
-
-
-
-
Regulation (EU) 2025/1234 (Amending Regulation (EU) 2021/2226 on eIFUs) Becomes Effective Today
Commission Implementing Regulation (EU) 2025/1234 amends the eIFU Regulation (EU) 2021/2226 to extend the scope to all professional use devices. […]
-
-
EU AI Act: Rules for GPAI models, Governance, Confidentiality, and Notified Bodies
As of today, under the AI Act Article 113(b), the following rules begin to apply: Notified bodies begin oversight (Chapter III, […]
-
-
Sign Agreement With Notified Body: Class D and IVDD Notified Body Certified IVDs
Manufacturers with IVDD legacy devices up-classed to Class D, or which were Notified Body certified under the IVDD, must have […]
-
-
EUDAMED Hybrid (Rome + Virtual) Workshop
To help industry prepare for the mandatory use of EUDAMED (expected to be January 2026), the Commission is hosting several […]
-
-
Use of EUDAMED Published in OJEU Today
The use of the EUDAMED 1) Actor, 2) UDI/Device, 3) Notified Bodies/Certificates, and 4) Market Surveillance modules was published in […]
-
-
EUDAMED Hybrid (Brussels + Virtual) Workshop
To help industry prepare for the mandatory use of EUDAMED (expected to be January 2026), the Commission is hosting several […]
-
-
Annual EMDN Code Revision: Monitor for Published Changes
EMDN codes are subject to change. Each year, the Commission publishes a list of all codes that have been newly […]
-
-
IMDRF Adverse Event Report (AER) Terms and Codes Updated
The IMDRF reviews AER revision requests annually and updates the codes as needed. The process to request code revisions is […]
-
-
Manufacturer Incident Report (MIR) Form v7.3.1 Now Mandatory
MIR Form 7.3.1 is now mandatory in Europe and Switzerland, replacing the old version (MIR 7.2.1). For more information, please […]