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 [...]
The European medical device regulatory framework is at a pivotal [...]
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 [...]