REGULATIONS

In addition to the certification made compulsory from law 93 /42/eec, implemented in Italy with the D.lgs.46/97 (download), There are many regulations and procedures for national and international standards which it is mandatory that the producer complies.

These certificates may be issued only by Notified Bodies (public or private bodies expressly authorized by the competent authorities of Community countries in which they are established to the issue of these certificates). These bodies are "notified" by each Member State to the European Commission, which assigns them a ID number and puts them in a special list (database on-line NANDO IS ).

On the www.salute.gov.it website, in thematic 'Area Medical Devices, is possible to find the list of 10 Notified Bodies Italian and therefore recognised in our country.

The code of the certification must be given on the label together with the serial number, the EC mark, and all indications that allow to identify the manufacturer.

The Italian Financial Law for the 2003 (L. 266/2002), has provided the implementation of General Directory of medical devices marketed in Italy (RDM), both to enable economic assessments on them by the various public entities involved in their purchase or in establish policies for the sector, both the definition of the reference price of the devices (Article 57, paragraph 1).

Furthermore, this article was determined that, for those purposes, the devices were classified into classes and subclasses homogeneous, instructing the Unique Commission of Medical Devices (CUD) to prepare the National Classification of medical devices (CND).

It became therefore necessary to create - in addition to the system for recording (in a database) of all devices, already provided by laws relating to medical devices - another record system, in the Directory, for medical devices when purchased from the SSN.

On this occasion, it is considered appropriate to include this second instrument (database) inside the first (the Directory), since it was collecting a subset of information relative to the larger set consisting of all the devices marketed in Italy, so as to provide the responsible parties the recording for both purposes with a single operation.

The regulatory environment of registration in the Database and the Directory was dictated by the Ministerial Decree dated 20 February 2007.

We consider important to know and evaluate the project and construction criteria in which a machine was bu il t and consider that all regulatory aspects are met.