European Union
Medical device market intelligence for European Union. Regulatory changes, competitor moves, and procurement trends.
Last 7 days
The Browne device by Albert Browne Limited is registered as a Class I medical device with UDI-DI 15055156325011.
The Melag device by Albert Browne Limited is classified as Class I and registered under UDI-DI 15055156300308.
The Browne device by Albert Browne Limited is classified as Class I and registered under UDI-DI 15055156323529.
Roche's VENTANA MMR RxDx Panel receives IVDR approval for five cancer types, enhancing diagnostic capabilities.
A vision-restoring implant has received CE Mark approval, enhancing digital health solutions in Europe.
Xeltis begins a European trial for Axess, a restorative synthetic haemodialysis access graft for kidney failure patients.
NextKidney BV acquired Dialyss Pte Limited to commercialize the Neokidney, a portable haemodialysis device by 2023.
RenalSense secured $14 million for Clarity RMS expansion in critical care monitoring across global markets.
Medtronic's Hugo robotic-assisted surgery system has received CE mark approval for use in Europe, targeting urologic and gynecologic procedures.
The WRAPSODY FIRST study shows promising 12-month results for the Wrapsody endoprosthesis in hemodialysis patients.
MDCG clarifies ethylene oxide regulation under MDR and IVDR for medical devices.
The FACT trial shows the FA-1 device significantly dilates superficial veins in kidney disease patients, enhancing AV fistula creation.
Transit Scientific's XO Score platform gains CE mark for treating PAD and ESRD in the EU, enhancing angioplasty options.
The EU Medical Devices Regulation (MDR) is effective from May 26, 2021, enhancing device safety and market access.
iVascular's iCover covered stent received CE mark approval for treating arterial lesions and aneurysms.
Merit Medical has enrolled the first patients in the WAVE study for its Wrapsody stent graft for dialysis access.
Xeltis reports promising results in vascular trials for restorative grafts, supported by €15M EU funding.
Hologic received CE mark for two molecular assays aiding transplant patient management on the Panther Fusion system.
The Parliament advocates for smarter regulation of AI in medtech, emphasizing safety and innovation.