The UPC has granted a preliminary injunction effective for Germany, France, Italy, the Netherlands and Ireland against a Chinese medical device manufacturer and its Dutch subsidiary over the ...
This article will examine market access outside the EU/EEA based on reliance and recognition. For countries outside the European Union (EU) and European Economic Area (EEA), regulatory reliance and ...
The UK government recently announced an indefinite extension to the use of CE marking for most goods. The extended recognition of CE marking does not, however, apply to medical devices. That said, the ...
Zap-X, a gyroscopic radiosurgery robot developed and manufactured by Zap Surgical, received a CE mark in 2021 under the European Union’s Medical Device Regulation (MDR). Zap Surgical CEO John Adler, ...
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