ATTIVITÀ

Organismo Notificato

Notified body

Director: Dott.ssa Roberta Marcoaldi
phone: (+39) 06 4990 6146-6145
mail: roberta.marcoaldi@iss.it; pecON-ISS@pec.iss.it

The Notified Body operates at the Istituto Superiore di Sanità (ISS, the National Institute of Health in Italy) carrying 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 meets the specific requirements of Regulation (EU) 920/2013.

The strucure is organized into two units:

  • Medical Devices Operating Unit
  • In vitro Diagnostic Medical Devices Unit

The Notified Body has implemented an organizational structure and made available personnel resources such as to allow it to meet the specific requirements also provided for by Regulation (EU) 920/2013.

In over 25 years of activity, the Notified Body has taken on a role of reference for companies operating on the national, European and non-European territory. To date, it is involved in the CE certification of over 200 manufacturers, and is currently the only Italian Notified Body designated for the certification of in vitro diagnostic medical devices.

The Notified Body actively participates in the work of the Italian and European technical tables in the regulatory field and is strongly committed to the training of internal and external personnel.

On 26 May 2021, Regulation (EU) 745/2017 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR) entered into full application.

By virtue of the new designation obtained on 13 January 2021, the ON ISS is now also active for the certification of medical devices in accordance with the new regulatory provisions.

The regulatory environment for IVDs is also currently evolving: regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices is in force in May 2017, so the date of application is set at 26 May 2022.

The ON ISS has also submitted its candidacy for this regulation; the evaluation process, which has already included an on-site audit in February 2020, is currently ongoing.

For the implementation of Regulation (EU) 2017/745 on medical devices (MDR), the ON ISS has chosen to support the activities of manufacturers with the design and implementation of a specially dedicated software available at https://www.iss.it/certificazione-organismonotificato.

For any administrative and financial information of the third-party services by the Notified Body of the Istituto Superiore di Sanità, please see the page https://www.iss.it/tariffe-dei-servizi-a-terzi

 

 

 



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