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News and Views July 2018


National registration:
  • Spain update
  • Latvia update



The additional national registrations (NR) in a number of member states are suddenly in focus with more and more clients. For many years we (MDSS) perform the NR on behalf of our clients (outside the EU) but as well for importers and distributors (within the EU). The NR needs to be done where required and may be performed by the entity equipped with the knowledge and experience, on behalf of the one who is responsible for it. Sounds complicated – it is.

The NRs are not harmonized!

Currently MDSS offers the NR for the following countries: Italy, Spain, Portugal, France, Belgium, Greek, Latvia and Slovakia. These are the countries where it was identified that the Manufacturer is responsible for the registration and MDSS performs them with the mandate of the manufacturer.

Here are two recent updates. Clients who have given the mandate to MDSS have been or will be informed of these updates.

Spain:
The old databank where all notifications were made till now is not available anymore and all notifications must be transferred from the old to the new databank. MDSS is urged to transfer all existing Spanish registrations at the latest with the next necessary update. This means that we will have to identify the registrations, verify their correct content and transfer them properly to the new databank. The current notifications in Spain remain valid until the transfer is done and the devices can further be placed on the Spanish market. MDSS assumes that the same charges as in the current price lists may be applicable but changes may be indicated depending of the resources needed now.

Latvia:
The State Agency of Medicines of the Republic of Latvia (ZVA) requires notification for Class IIa, IIb, III, AIMD and some IVD devices. While in the past class IIa medical devices were exempted from the notification, with the entry into force of the Regulation no. 689 it is now mandatory to notify medical devices of risk class IIa as well.

Please check whether your Class IIa devices are already notified with the competent authority or contact MDSS for it. The same charges as for the other risk class products apply.

MDSS has implemented solid processes, which ensures a timely notification of your products. Clients from all over the world rely on the MDSS services in Europe and have given the mandate to MDSS with our Maintenance agreement for the NRs.

Should you have any questions please let us know.

Your MDSS Team