After a shove from European Parliament, EU member states, and industry stakeholders, the European Commission (EC) issued ...

Medical device manufacturers and notified bodies in the European Union may qualify for free advice on orphan medical devices under a new pilot program launched by the European Medicines Agency (EMA).

European authorities have recommended changes to the regulatory framework to keep pace with the progress of the ...

Carthera has received an orphan medical device status endorsement for its SonoCloud ultrasound system for treating brain disorders under a new pilot programme by the European Medicines Agency (EMA).

Professionals have the opportunity to enhance their knowledge on the complex regulatory changes under the MDR and IVDR, gain insights into future developments, and understand their impact on market ...