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News and Views June 2011 Eudamed Registration

Eudamed

Eudamed Registration:

Since May of this year the Eudamed became mandatory. Eudamed is a databank implemented by the European Commission.  This new databank was enforced with a Commission Decision.  A Decision is a legal tool for the execution of certain aspects by the Commission. You will find the “COMMISSION DECISION of 19 April 2010 on the European Databank on Medical Devices (Eudamed)“ here: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:102:0045:0048:en:PDF

 

This Decision mandates the member states to forward certain medical devices information to the databank.  Therefore the data are being collected in each country where the manufacturer or for that matter the authorized representative (AR) is located.  The data is only available to the Commission and Member States.

 

MDSS being your AR located in Germany must notify products with the German authority.  Due to the national implementation slight deviations apply as in most countries.  The German notification is straightforward and the German Authority currently does not impose any fees for the notification as opposed to other countries.  However, due to changes with the German registration imposed by Eudamed the registration of products is more detailed than in the past. For example the registration previously was based strictly on product groups or families and the preferred code used was the UMDNS code.  Now detailed product information such as the “Device Name /Make or, where not available, generic name“ must be provided. This leads to increased notification as well as additional discussions on what is required to be notified

 

MDSS ceased on May 1st, the notification of In-Vitro Diagnostic Medical Devices to all other countries according to article 10.6 of the IVD directive. A very burdensome process finally disappeared due to the implementation of Eudamed.  All IVD manufacturers were informed accordingly.

 

MDSS change of the notification procedure:

MDSS has updated its notification form and has to mandate the new form in order to ensure the correct detail data submission on behalf of its clients.  With any new or changes to existing notifications of products with the German Authority MDSS will update all existing registrations accordingly.  All of this will require additional resources and we will contact you early on in terms of any contract updates if needed.

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