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.
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.
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:
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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