Direttore: 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) 2017/746, please consult the document “Certification flow Reg. 2017/746”.
By virtue of the designation obtained pursuant to Regulation (EU) 2017/746, the NB ISS is active for certification in accordance with this regulatory regime and maintains the activities necessary to carry out the surveillance of certifications previously issued pursuant to Directive 98/79/EC on in vitro diagnostic medical devices.
For information regarding the management of preliminary documentation and the submission of the certification application, the manufacturer can contact the NB ISS at the dedicated email address ON-ISS.ivdsegreteria@iss.it;
Activities required for submitting the certification application:
• The manufacturer fills out the pre-request and sends it to the following email address: ON-ISS@pec.iss.it (manufacturers based outside of Italy can send the form to the email address: ON-ISS.ivdsegreteria.iss.it.
• The notified body formulates a quote that is sent to the manufacturer, who has 10 days to accept it. In this case, an agreement will be signed between the notified body and the manufacturer that regulates the certification service.
• Finally, the Manufacturer must fill out the certification application (within 30 days of acceptance of the quote), attaching the relevant technical documentation (technical product file and quality management manual, to be sent upon request for a GARR Voucher to the address ).
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.
