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MDSS
serves clients' specific needs with changes
of products and regulations.  Each client is unique and MDSS customizes the solution for each client individually.

Compulsory Registration in Italy

According to the decree issued by the Italian Ministry of Health on 20th of February 2007, medical devices of class I, IIa,
IIb and III, assembled systems, kits and active implantable medical devices need to be registered in a specific way
before placing them on the Italian market.

Registration Timelines

Since May 1, 2007 – Notification of all new devices sold to the Italian market.
Until January 1, 2009 – Notification of all devices already sold in Italy before April 30th, 2007.

Products which are not registered according to the above timelines can no longer be sold to the SSN (National Health System),
and some manufacturers already encountered difficulties in selling their products even before the end of the deadline.

The devices are requested to be registered electronically into the new database of the Italian Ministry of Health and the
complex registration procedure can only be performed after being specifically authorized by the Italian Ministry of Health.

The specific authorization procedure for the submission of the registration is very complex and may take several weeks including
traveling to Italy to pick up the ID card which is necessary for the electronic signature. MDSS went through this process for its
clients and now offers it to all manufacturers who wish to avoid certain pitfalls through an independent representative.

For the time being the registration in the Italian Index does not apply to custom-made or IVD devices.

Appoint MDSS to perform the Italian registration on your behalf

As independent Representative for European and non-European manufacturers MDSS is authorized to perform the Italian registration
on your behalf. This helps you to keep the highest business flexibility in your distribution network. Certainly we do guarantee
that all information and documentation will be handled with utmost confidentiality.

For further information please contact:
Medical Device Safety Service GmbH
Schiffgraben 41
30175 Hannover
Germany

Please also refer to our newsletter which we published on this topic http://www.mdss.com/articles/newsandviews10.htm