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MHRA calls for industry input on keeping EU law, IVD classification & more
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a consultation period calling on the public ...
European committee takes a second look at Alzheimer’s drug and now says it should be approved
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...
pharmaphorum2d
The booming medical device sector: How well are suppliers adapting to new regulatory demands?
Peter Muller and Mike Baird of Schlafender Hase explore how Class 2 and 3 device manufacturers in Europe and the US are coping with rising Agency controls. As medical devices become more critical ...
hospitalhealthcare2d
Remanufacturing single-use medical devices: views from England, France and beyond
Bob Unwin and Josselin Duchateau share an overview of remanufacturing single-use medical devices at Stepping Hill Hospital ...
Yahoo Finance4d
Envoy Medical secures European patent for hearing device
Implanted hearing systems specialist Envoy Medical has secured a European Patent for a hearing device. The patent no. 3858425 granted by the European Patent Office is titled "Implantable Modular ...
MEPs delay confirmation of Orban's commission pick citing concerns over women's health
His confirmation has been postponed as he failed to impress MEPs, slipping on reproductive and sexual rights. View on ...
Yahoo6d
EU does not want trade war with Beijing, says bloc's ambassador to China
Speaking at an event in Shanghai, the EU's Ambassador to China Jorge Toledo said talks with European medical device makers had shown they were being discriminated against in Chinese public ...
Morningstar9d
SYNDEO Medical Announces European MDR Approval for Two Product Brands
SYNDEOPack Interventional Procedure Packs™ and Xssential Rapid Delivery Procedure Packs™, have received European Medical Device Regulation (MDR) approval. “We have observed over the years ...