New EU Harmonized Standards for Surgical Clothing, Medical Face Masks, and Sterilizers
What is Decision (EU) 2025/2078? On 17 October 2025, [...]
Switzerland adopts EU rules on electronic instructions for use for medical devices
On 8 August 2025, Swissmedic announced the immediate implementation [...]
New EU manual on borderline & classification of medical devices and IVDs
The European Union has released the 4th edition of [...]
Australia’s approach to regulating software-based medical devices
The rapid rise of digital health technologies is transforming healthcare [...]
Swissdamed UDI Devices module: medical device registration now available
On 18 August 2025, Swissmedic launched the new UDI Devices [...]
China and Malaysia launch reciprocal medical device reliance pilot programme
On 30 July 2025, the regulatory authorities in China and [...]
Swissmedic information sheet on systems and procedure packs
From 4 August 2025, Swissmedic clarifies the obligations for systems [...]
FDA MDUFA Small Business Benefits: eligibility and reduced fee options
The Medical Device User Fee Amendments (MDUFA) authorize the [...]
MDR and IVDR Certification: Key Insights from the 14th NB Survey
The availability of medical devices in the EU is closely [...]
MHRA Early Access: a new pathway for innovative medical devices in the UK
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has [...]
