The laws concerning medical devices (instruments, equipment, systems, substances or other products) are harmonised.
In Italy, the free circulation of medical devices used either on their own or in combination, including the computer software, and used on man for diagnosis, prevention, monitoring, therapy or alleviation of a disease, injury or handicap, the analysis, replacement or modification of the anatomy or physiological process as well as interventions on conception are regulated by:
- LD 46/97 “Implementation of Directive 93/42/EEC, concerning medical devices”,
- LD 507/92 “Implementation of Directive 90/385/EEC on active implantable medical devices”
- LD 332/00 “Implementation of Directive 98/79/EEC on in vitro diagnostic devices”.
Medical devices must bear CE Marking to be marketed and are classified in 4 classes of growing risk according to criteria that take into account the intended use, duration of use, degree of invasiveness, methods of operation and anatomical site on which they exert their action. Only the devices associated to an extremely low risk (class I) may be CE marked in self-certification. For all others, intervention by a Notified Body is required, an entity authorised by the Ministry of Health to perform the activity to assess conformity that allows the device to be CE marked.
The manufacturer, according to the risk class, may request intervention by the Notified Body choosing from different conformity assessment procedures, even combined, set forth by the Directive and described in its Annexes.
The new EU regulation 920/2013 makes the selection criteria of certification bodies stricter. As a matter of fact, the audit for the issuance, renewal and extension of the notification is performed by a Joint Assessment Team that includes, together with the inspectors of the General Directorate of medical devices and of the pharmaceutical department of the Ministry, a European Commission organisation and representatives of the Ministries of Health of two member states.
As of September 2016 ICIM, having passed the audit by the Commission, is the first certification body in Italy that has received from the Ministry of Health renewal and extension of the authorisation to issue CE marking for medical devices according to the new EU regulation.
ICIM complies with the new regulations and it is among notified bodies on the Ministry of Health’s website and in the list of notified bodies in Europe
To know the categories of products for which ICIM is a notified body, see NANDO – New Approach Notified and Designated Organisations
For further information: Vanda Spina (phone +39 02 72534204, e-mail firstname.lastname@example.org)
To find out about other related certification services: