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 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...
EUDAMED Release notes
Production 2.27.0 – 2026 Download...
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...
Regulatory Update â The Clock is Ticking for Legacy Device IVDs
As we move into the second quarter of 2026, the regulatory landscape for In Vitro Diagnostics (IVD) in the European Union is reaching a critica...
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...
