Responsible: Dr. Roberta Marcoaldi
phone: (+39) 06 4990 6146-6145
mail: roberta.marcoaldi@iss.it; pec: on0373@pec.iss.it
Activities
The Notified body 0373 of the Italian National Institute of Health (ISS) carries out CE certification activities for:
- Medical devices (DM) pursuant to Directive 93/42 / EEC and subsequent amendments
- In Vitro Diagnostic Medical Devices (IVD) pursuant to Directive 98/79 / EC and subsequent amendments
For the certification of medical devices, the Italian National Institute of Health was notified by the Italian Government to the European Commission on 14/02/1995 and obtained the renewal of the designation on 5/7/2017; the notification concerned the designation to carry out certification tasks in Italy and specifically the CE certification activities of medical devices following all the conformity assessment procedures envisaged by the European directive. The CE certification issued by the Italian National Institute of Health allows manufacturers of medical devices to market products on the European market.
For the in vitro diagnostic medical device certification activity, the Italian National Institute of Health was authorized by the Ministry of Health with a Decree on 12 November 2009 and obtained the renewal of the designation on 22/10/2015; this designation allows the compliance assessment procedures envisaged by Legislative Decree n. 332/2000 to be carried out in accordance with all compliance assessment procedures foreseen by the European directive. The CE certification issued by the Italian National Institute of Health allows manufacturers of in vitro diagnostic medical devices to market products on the European market.
