09/09/2011

Obelis O.E.A.R.C.

Medical Device Registration in Italy

“With reference to art. 14 bis European Data Bank as per 93/42/EEC Directive – 2002 Edition we inform you that on 20th February 2007, Italian Ministry of Health enacted a Ministerial Decree concerning the Registration in the Medical Device Inventory.”

The above mentioned Registration into Ministry Data Bank aims to improve vigilance on the European market through the knowledge of every medical device marketed and used and to improve their own traceability through the Inventory Number, ascribed to the medical devices themselves.

This obligation in Italy is compulsory for the admission to Public Tenders of medical devices.

Timeline
• 1st August 2007: Italian MoH implements new requirements for marketed medical devices
• 31st December 2008: Original registration deadline
• 1st January 2009: Deadline is extended until April 30th 2009
• April 30th 2009: Deadline is extended
• December 31st 2009: New Registration Deadline

Here is the link to the announcement on the MoH website (in Italian):
http://www.ministerosalute.it/dispositivi/newsDispo.jsp?id=669&lingua=italiano

The following is an excerpt with the corresponding English Translation.

“Con Ordinanza del 29 aprile 2009 viene disposto che fino al 31 dicembre 2009 i dispositivi medici di cui all’articolo 5, comma 2 del decreto ministeriale 20 febbraio 2007 possono essere acquistati, utilizzati o dispensati nell’ambito del Servizio sanitario nazionale ancorché privi del numero identificativo di cui all’articolo 3 del medesimo decreto ministeriale e non pubblicati nel Repertorio dei dispositivi medici.”

English Translation:
By Order of 29 April 2009 is provided that until 31 December 2009 the medical devices referred to in Article 5, Paragraph 2 of the Ministerial Order of 20 February 2007 can be acquired, used or disposed as part of the National Health Service even without the identification number referred to in Article 3 of the same Ministerial Order and not published in the directory of medical devices.