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 [...]
A new vision for EU governance in the medical device sector: the Notified Bodies’ perspective
The European medical device regulatory framework is at a pivotal [...]
Can I appoint two different representatives for devices in the same generic group?
No. Under the MDR and MDCG guidance, a manufacturer cannot [...]
US FDA vs EU MDR: Key differences in medical device classification
Selling a medical device in both the United States and [...]
Authorized and Legal Representative: key roles for compliance
In the global regulatory environment for medical and in vitro [...]
Why the UK is moving toward EU-aligned standards for IVDs
The UK’s decision to adopt EU Common Specifications for [...]
