MIR form v7.3.1 (update 23 April 2026) becomes mandatory for serious incident reporting under MDR & IVDR. ✅ Action needed today: Con...
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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...
Newsflash – Recently Harmonized Standards
Recently, twelve standards were added to the list of harmonized standards under the EU MDR (Regulation (EU) 2017/745). The list of standards, p...
UK MHRA Proposes Indefinite Recognition for CE-Marked Devices
The UK’s regulatory landscape for medical devices just took a major leap toward long-term certainty. On 16 February 2026, the MHRA released a...
