Registrations versus Notifications for Medical Devices Europe

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19 September 2018

Notifications are published on EU Level after receiving the CE Approval

  • No legal obligation of the authorities to reply
  • Registration in several countries in Europe

In some countries in Europe there is an obligation of registration the Medical Device like: Italy, Portugal, France ,Greece ,Latvia

The manufacturers need to register Medical Devices and wait for an answer from Authorities.

Example:

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

Summary :

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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Last modified on Wednesday, 19 September 2018 19:46
Liat Nadel

Liat Nadel – Jurist – Regulatory Affairs & Import Export Expert Medical Devices – VP RA Affairs & COO L.S. Marketing & Registration