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...
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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...
The New Era of FDA Inspections
As of February 2, 2026, the landscape for medical device manufacturing has officially shifted. The FDA has fully implemented the Quality Manage...
EUDAMED user guide – UDI Devices
The European Commission has published a new EUDAMED User Guide – UDI Devices (Production v2.22.0 – 2026), providing comprehensive and...
Titanium Dioxide and MDR/IVDR: clarification following the CJEU judgment – what Manufacturers need to know
With its judgment of 1 August 2025, the Court of Justice of the European Union dismissed the appeals against the judgment of the General Court ...
