Notified body

Responsible: Dr. Roberta Marcoaldi
phone: (+39) 06 4990 6146-6145
mail: roberta.marcoaldi@iss.it; pec: on0373@pec.iss.it

The Notified Body (ON ISS), divided into DM operating unit and IVD operating unit, operates at the Italian National Institute of Health (ISS) and carries out CE certification activities for:

Medical devices (DM) according to Directive 93/42 / EEC and subsequent amendments
In Vitro Diagnostic Medical Devices (IVD) according to per Directive 98/79 / EC and subsequent amendments

The Notified Body (ON ISS) meets the specific requirements of Regulation (EU) 920/2013.

In over 20 years of activity, the Notified Body (ON ISS) has assumed a reference role for companies operating on national, European and non-European territory. It is involved, to the present day, in the CE certification of over 200 manufacturers and is currently the only notified body in Italy designated for the in vitro diagnostic medical devices certification.

The Notified Body (ON ISS) actively participates in the work of the italian and european technical tables in the regulatory area and is heavily involved in the training of internal and external personnel.

On May 26, 2021, Regulation (EU) 745/2017 of the European Parliament and of the Council relating to medical devices (MDR) came into force. The Notified Body (ON ISS) has been designated as a Notified Body (ON ISS) for the certification of medical devices.

The regulatory context of IVDs is evolving: the new Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices has been in force since May 2017. The designation of the Notified Body (ON ISS) for this regulation is in progress.

For the implementation of the Regulation (EU) 2017/745 on medical devices (MDR), the Notified Body (ON ISS) has chosen to support the activities of the Manufacturers through software available at https://www.iss.it/en/web/iss-en/on-certification