Responsabile: Dott.ssa Roberta Marcoaldi
telefono: (+39) 06 4990 6146
mail: ON-ISS.direzione@iss.it; pec: ON-ISS@pec.iss.it
To carry out the conformity assessment procedures according to Regulation (EU) 2017/745, consult the document “Certification flow Reg. 2017/745”.
For the implementation of Regulation (EU) 2017/745 on medical devices (MDR), the notified body of Istituto Superiore di Sanità (NB ISS) has chosen to support the activities of Manufacturers through software available on its website.
The software can be used:
• to the formulation and management of the quote request (pre-request)
• to the formulation and management of the certification application
• to send the technical documentation (technical file of the medical device and quality management manual)
The software manages the entire documentary flow and a guided procedure will help the Manufacturer to enter the necessary information aimed at issuing the quote for the certification service offered by NB ISS.
In case of acceptance of the offer formulated by NB ISS, the Manufacturer will be asked to sign the agreement that regulates the certification service. Subsequently, the Manufacturer will have to fill out the CE application by attaching the complete technical documentation including the relevant attachments in folders arranged in a reserved and protected cloud environment.
All the information entered in the various forms 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 user chosen by the Manufacturer for the registration of the company account will be guided along the path on this page.
After registration, the user will receive the access credentials via email prior to continue with the activities from the "login" link on the page.
Privacy information
For privacy relating to the activities of CE certifications of medical devices and in vitro diagnostic medical devices see the page ON ISS privacy.
