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News and Views May 2017



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News and Views June 2011: National Registration


National registration:

Throughout the last couple years you may or may not have become aware of additional national registration in particular member states, which is allowed by the directive according to MDD Article 14 second paragraph.  The additional national notification requirement is NOT mandated for the AR to perform!  In most cases the distributor/Importer should notify the products. In a few cases the Manufacturer independent of his location is responsible.  However, the AR is allowed to notify the products on the manufacturers behalf. Certainly a notification is not required if products are not being placed on those markets.  Those national registrations are more rigorous and document reviews (e.g. translation of label and instructions for use) may be conducted by the Authorities. 

 

Please note that these additional national registrations are independent of the Eudamed registration.  For example MDSS informed its clients extensively of the Italian registration which was implemented in 2007.  This registration requirement is bestowed upon the manufacturer independent where he is located.  The manufacturer may appoint just anyone for the data entry to perform. The reason others perform the notification is simply because to achieve the access to the databank and the Italian notification itself is complicated and cumbersome.  The language barrier as well is a hurdle why a manufacturer outside Italy may not be able to perform such notifications.

 

MDSS service regarding national notifications:

MDSS offers this service for various countries.  Currently MDSS notifies products in other countries and implemented specific procedures for Italy, Spain and Portugal.  Since inception MDSS performs the Italian notification on behalf of its clients and other manufacturers. There are specific advantages for the client to have those national registrations performed by the AR in your case MDSS.  In order to service our clients the best MDSS hired personnel fluent in those languages.  Please contact us for details.



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