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 ...
The CE Marking approval indicates that a medical device meets the requirements of the European Medical Devices Directive. Until now, Materialise’s personalized devices made use of the custom-made ...
focused on understanding the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing ...
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 ...
Indefinite recognition of CE-marked medical devices would benefit the health tech sector, say two local medical technology consultancies.
The UK government has launched a consultation asking whether medical devices with CE marks issued in the EU and sold in Great Britain should be recognised indefinitely. The Medicines and Healthcare ...
Pulsecath BV secured a CE mark under the Medical Device Regulation (MDR) for its Ivac 2L system, a percutaneous mechanical circulatory support device, four years after it began the process. “It took ...
ST. PAUL, Minn.--St. Jude Medical, Inc., a global medical device company, today announced European CE Mark approval of its AMPLATZER™ Amulet™ Left Atrial Appendage Occluder. The Amulet device is used ...
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