A minor linguistic discrepancy between the English version and the German version of the EU Medical Device Regulation (MDR) creates a point of ...
Categories
- Downloads (4)
- EUDAMED (1)
- MDSS Forum+ (7)
- NEWS (114)
- Australia & New Zealand (3)
- EU IVDR (46)
- EU MDR (56)
- Switzerland (15)
- United Kingdom (20)
- US FDA (6)
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...
🚨 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...
MHRA Updates Guidance on Modifications to Clinical Trial Approvals
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance “Clinical Trials for Medicines: Modifying a Cl...
FDA Updates Guidance on Exemptions for Certain Unclassified Medical Devices from Premarket Notification Requirements
The U.S. Food and Drug Administration (FDA) has issued an updated guidance document, “Intent to Exempt Certain Unclassified Medical Devic...
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...
