European Union

Sixty professionals have been preparing for the implementation of the EU-MDR for two and a half years.

Future regulations for integrated drug-device combinations are being discussed by EMA.

Tandem has received CE mark approval for its automated insulin delivery system for type 2 diabetes and pregnancy.

The article analyzes regulatory approaches to cybersecurity for AI-enabled medical devices in Korea, the US, and EU.

The EMA provides expert panel opinions on Class III and Class IIb medical devices for medicinal product administration.

The European Commission has expanded the list of well-established technologies under the Medical Device Regulation (MDR).

The EU Commission has updated medical device software classification under MDR/IVDR, delaying the AI Act.

Roche has received CE Mark approval for its blood test designed to confirm Alzheimer's disease.

The article analyzes cybersecurity regulations for AI-enabled medical device software in Korea, the US, and the EU.

Abbott has received CE mark approval for its dual glucose-ketone sensor.

The webcast focuses on optimizing multi-region submissions for MDR, FDA, and EU AI Act compliance.

The EMA has finalized the CPAR for the SURGIFLO Haemostatic Matrix Kit, relevant for medical devices.

The webcast provides guidance on managing EU MDR and 510(k) compliance simultaneously for medical devices.

The EMA provides expert panel support for orphan medical devices in Europe.

EUDAMED is the European database for medical devices regulated by BfArM.

Olsun Surgical's device is registered as Class I in EUDAMED with UDI-DI 08964003959043.

Promedon by PROMEDON S.A. is registered as a Class IIB medical device in EUDAMED.

Promedon by PROMEDON S.A. is classified as Class IIB medical device with UDI-DI 07798121803558.

DIRUI INDUSTRIAL CO., LTD has registered a D-Dimer Detection Kit classified as IVD general risk.

RF Medical's Big-Tip device is classified as Class IIB and registered under UDI-DI 08800142905902.