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 high-risk [...]
When is the Master UDI-DI mandatory for contact lenses and spectacle frames?
The Master UDI-DI will become mandatory for spectacle frames, spectacle [...]
India strengthens its regulatory presence in Andhra Pradesh: what it means for manufacturers
India has announced the designation of the first regulatory body [...]
New EU regulation on e-IFU: what changes for medical devices?
On 25 June 2025, the European Commission published a [...]
