Responsabile: Dott.ssa Roberta Marcoaldi
telefono: (+39) 06 4990 6146
mail: ON-ISS.direzione@iss.it; pec: ON-ISS@pec.iss.it
By virtue of the designations obtained pursuant to Regulation (EU) 2017/745 and Regulation (EU) 2017/746, NB ISS is active for certification in accordance with both regulatory regimes and maintains the activities needed to carry out the certifications surveillance previously issued pursuant to Directive 93/42/EEC on medical devices and Directive 98/79/EC on in vitro diagnostic medical devices.
For the implementation of Regulation (EU) 2017/745, NB ISS has made available, to page Medical device certification, a specifically dedicated software, to manage the request for preliminary information and the submission of the application for EU certification by Manufacturers.
For the implementation of Regulation (EU) 2017/746, the NB ISS has made available, on the IVDR Certification web page, a support to manage the request for preliminary information and the EU certification submission by Manufacturers
In accordance with the requirements of their Quality Management System, Manufacturers/Representative may submit a complaint with a specific and motivated communication,
depending on whether this refers to medical devices or in vitro diagnostic medical devices, respectively to the following email addresses:
ON-ISS.dmsegreteria@iss.it - e-mail MD secretariat
ON-ISS.ivdsegreteria@iss.it - e-mail IVD secretariat
Complaints received will be managed by NB ISS in accordance with the quality management system.
Any communications/reports from other third parties may still be forwarded to the email addresses above.
For administrative and financial information on the services to third parties offered by the notified body of Istituto Superiore di Sanità, see the page tariffe dei servizi a terzi.
Privacy information
For privacy relating to the activities of CE certifications of medical devices and in vitro diagnostic medical devices see the page ON ISS privacy.
