ACTIVITY

Notified body

Medical devices certification

For the implementation of the Regulation (EU) 2017/745 on medical devices (MDR) the Notified Body of the Istituto Superiore di Sanità (ON ISS) has chosen to support the activities of medical devices' manufacturers with software available on its website.

The software can be used for:

  • formulation and management requests for quotations (pre-requests)
  • formulation and management of the application for certification
  • sending technical documentation (product technical file and quality management manual).

The software manages the entire document flow and the Manufacturer is driven in entering the necessary information aimed at issuing the estimation cost for the certification service offered by the ON ISS.

In case of acceptance of the offer formulated by the ON ISS, the Manufacturer will be asked to sign the agreement governing the certification service. Subsequently, the Manufacturer will have to fill in the certification application by attaching the requested technical documentation with the relevant attachments in folders provided in a confidential and protected cloud environment.

All the included information filled in the various sheets created by the software are transformed into a pdf file, which is sent to the Manufacturer for the electronic signature by its legal representative.

The registration of the user chosen by the Manufacturer for the creation of the company registration will be guided through the paths on this page.

After registration, the user will receive the login credentials via e-mail in order to continue with the activities from the "login" link on the page.