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...
Regulatory Update — 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 “substantial” under the MDR/IVDR—and when must your Notified Body be informed? MDSS is seeing a rising number of quest...
New EU Packaging Regulation (PPWR) – briefly explained
With Regulation (EU) 2025/40 (PPWR), the EU introduces new rules for packaging. This also affects medical devices and in vitro diagnostic devic...
Upcoming TGA Unique Device Identification (UDI) Requirements
The Australian Therapeutic Goods Administration (TGA) is implementing Unique Device Identification (UDI) requirements for medical devices sup...
Goodbye DMIDS, Hello EUDAMED!
Germany switches fully to EUDAMED The German authority BfArM has announced that EUDAMED will replace all national device notifications in Germa...
Navigating the New MDSAP Audit Approach (v.10)
The landscape of global medical device compliance officially shifted on February 2, 2026. With the U.S. FDA’s Quality Management System Regul...
