Direttore: Dott.ssa Roberta Marcoaldi
telefono: (+39) 06 4990 6146
mail: ON-ISS.direzione@iss.it; pec: ON-ISS@pec.iss.it
Activities
The Notified Body (NB ISS) belongs to the Istituto Superiore di Sanità and carries out certification activities for:
· Medical devices
· In vitro diagnostic medical devices
In consideration of the above activities, the NB ISS is divided into:
· Medical Devices Unit (UO-DM)
· In vitro Diagnostic Medical Devices Unit (UO-IVD)
The NB ISS has implemented an organizational structure and made available personnel resources prior to respond to the specific requirements set out in current legislation.
The NB ISS actively participates in the work of Italian and European technical tables in the regulatory field and is strongly committed to training activities for internal and external personnel.
In over 25 years of activity until today, the NB ISS has assumed a reference role by intervening in the certification processes for manufacturers operating on the national, European and non-European territory.
On February 16, 2021 and September 11, 2024 respectively, NB ISS obtained the designation pursuant to Regulation (EU) 2017/745 and Regulation (EU) 2017/746, and for the latter it is the only Italian Notified Body designated to date.
By virtue of these designations, NB ISS is therefore active for certification in accordance with both regulatory regimes, maintaining 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.
