Obelis European Authorized Representative Center"CE Marking Consultants with a Reputation for Excellence"
Since 2007, all classes of medical devices to be sold on the Italian territory are to be registered with the Italian Ministry of Health Database allowing them access to the public and private sectors (Class I devices are exempt unless required to be sold to the public sector, in which case, they must be registered as well).
As of January 24th, 2012, a new rule was introduced, waiving the required 100 Euros Registration Tax on medical devices registered in Italy. This was mainly due to the increase of 5.5% of the fee for promotional expenses. This new law came into force upon its publication in the Gazzetta Ufficiale, on the 23rd of March, 2012.
Registration of medical devices is mandatory to all manufacturers wishing to place their devices in Italy. Such national registrations are more and more common in Europe and can be found also in Portugal, France, Greece & Latvia and for IVDs, in spite of decision 2010/227/EU of the EU Commission, national notifications of IVDs are required also in Italy, Portugal, Germany & Latvia;
It is common that such registrations in Europe require the GMDN codes to be provided – Obelis as an official consultant of the GMDN Agency provides solution to this requirement as well;
As it is obligatory for non-EU manufacturers to designate an Authorized Representative in Europe, the Authorized Representative is to complete any national registration and notifications of medical devices to European National Authorities - Read all about why your distributor should never be your EC Rep.
As always, prior to national registrations, a device must be correctly CE marked and manufacturers must fully comply with the provisions of the Medical Device Directive 93/42/EEC. See the full list of services related to medical devices that Obelis can provide you with.
To find out more about how to comply with the new registration procedure please, Contact us.
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