For the implementation of Regulation (EU) 2017/745 on medical devices (MDR), the Notified Body of the Istituto Superiore di Sanità has chosen to support the activities of manufacturers through a software available on its website.
The software can be used:
- for the formulation and management of the request for quotation (pre-request)
- for the formulation and management of the application for certification
- for sending the technical documentation (technical product file and quality management manual)
The software manages the entire document flow and the Manufacturer is guided in entering the necessary information aimed at issuing the estimate for the certification service offered by the Notified Body.
In case of acceptance of the offer formulated by the Notified Body, the Manufacturer will be asked to sign the agreement that regulates the certification service. Subsequently, the Manufacturer must fill in the certification application by attaching the complete technical documentation of the relative attachments in folders prepared in a reserved and protected cloud environment.
All the information entered in the different cards made available by the software is transformed into a pdf document that is sent to the Manufacturer for the electronic signature of the legal representative.
The registration of the user chosen by the Manufacturer for the creation of the company's users will be guided in the paths on this page.
After registration, the user will receive the access credentials by e-mail so that he can continue the activities from the "login" link on the page.