The manufacturers need to register Medical Devices and wait for an answer from Authorities.
Italy: CE + Registration – for all classes except class I – but can not be sold to the public.- Registration Time Frame approximately 4 weeks
Portugal- CE Registration for all classes except class I – registration Time Frame – 4 weeks
France – CE + Registration , all classes except class I , Registration Time Frame approximately 4 weeks
Class I Medical Devices – need premarket notification in all EU countries
National Registration in EU countries are in addition to the CE Marking
EU Authorized Representative are the professional RA Experts for registrations in EU.
The new regulations in Europe – forecast to enable all countries in Europe registration at EU Level ....
L.S.Marketing & Registration
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