Can I appoint two different representatives for devices in the same generic group?
No. Under the MDR and MDCG guidance, a manufacturer cannot [...]
No. Under the MDR and MDCG guidance, a manufacturer cannot [...]
Selling a medical device in both the United States and [...]
In the global regulatory environment for medical and in vitro [...]
The UK’s decision to adopt EU Common Specifications for high-risk [...]
The Master UDI-DI will become mandatory for spectacle frames, spectacle [...]
India has announced the designation of the first regulatory body [...]
On 25 June 2025, the European Commission published a [...]
The AI Act applies to software intended to fulfil a [...]
To legally publish a medical device software (MDSW) app [...]
Starting 16 June 2025, new post-market surveillance (PMS) obligations will [...]