Since the European Union’s main aims include consumer protection and ensuring product safety, you might be forgiven for thinking that the EU’s rules in those areas would be clear and straightforward.

CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (Nasdaq: CERS) announced today the CE mark approval of its next-generation LED-based illumination device, or the INT200, for the INTERCEPT Blood ...

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 ...

SEATTLE--(BUSINESS WIRE)--Tasso, Inc., the leading provider of patient-centric clinical-grade blood collection solutions, today announced it received CE Mark certification for its Tasso+™ device, a ...

(click to enlarge)Average total FDA review days from filing to approval for original PMAs and panel track PMA supplements. Some of these products can now be reviewed for marketing in Europe within 45 ...