MDSS EUROPEAN AUTHORIZED REPRESENTATIVE SERVICES MDSS CONSULTING   ENGLISH    GERMAN    CHINESE

Get a Quote from MDSS Your Authorized Representative forMedical Devices and In Vitro Diagnostic Devices

News Updates
  • Looking for a suitable GMDN-Code?
    MDSS can assist you to determine an appropriate code for your products!
    more


  • Have MDSS, your Authorized Representative, apply for a Free Sales Certificate/Certificate of Marketability on your behalf!
    more


    
HIGHLIGHTS
Keep up to date!

"The NEW CE MARKING"
Get your questions answered for the NEW REGULATION
– THE MDR/IVDR!!!

more...


In-House Workshops
"The NEW CE MARKING"
Book now
to make sure you’re ready to survive and thrive!



Cosmetic Products in Europe

Latest News




EVENTS
Join us!

MDSS Roadshow
- "The NEW CE MARKING” 



*Eligible for a total of 6 RAC credits



Meet us!


AACC Clinical Lab Expo
July 31-02 August, 2018
Chicago, USA
Booth #4052

RAPS
October 01-04, 2018
Vancouver, BC, Canada
Booth #307




Contact MDSS

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

Phone
(+49)-511-6262 8630
FAX
(+49) -511-6262 8633

Click here to
contact us





National Registration Italy

 National Registration of Medical Devices with the Italian Authority

According to the Italian Decree of December 21, 2009 manufacturers are obliged to register their class IIa, IIb and III  medical devices in Italy.  The registration of risk class I products is voluntary.

The  registration  into  the databank of the Italian Ministry of Health  must be made online. To get access to the databank you have to apply for an authorization from part of the Authorities.   In addition, a smart card is required to digitally sign the data.

The specific authorization procedure for the submission of the national registration is very complex and may take several weeks including travelling to Italy to pick up the Smart Card which is necessary for the electronic signature. 

As Authorized Representative MDSS went through the process and now offers this notification service to all medical device manufacturers who wish to avoid certain pitfalls.

 

Please note: According to recent changes the Italian Ministry of Health has abolished the €100 fee which so far was necessary to inscribe products into the "Repertoiro"

Medical Device manufacturers established in non-member countries of the EU are obliged to designate a European Authorized Representative.

Appoint MDSS to perform the  Italian Registration on your behalf!

Outsourcing registration processes and delegating this obligation to an independent entity helps you to keep the highest business flexibility in your distribution network.  We guarantee that all information and documentation will be handled with utmost confidentiality.

 

Our service includes:

  • access to the Italian database
  • consultancy on the data requirements
  • communication in Italian language with the Competent Authority
  • advice regarding the classification of your devices into the Italian nomenclature system
  • insertion of the relevant product information into the Italian database
  • the necessary digital signature

Custom-made devices must be also notified in Italy. The procedure differs from the notification of medical devices. Please contact us for further information. 


Medical Device Safety Service GmbH
Schiffgraben 41
30175 Hannover
Germany

Phone: +49 511 6262 8630
Fax: +49 511 6262 8633

Or Click Here for our Contact Form