From 26 October 2023 it is possible to enter in the national database of medical devices both information relating to systems and procedural kits (art. 22, paragraphs 1 and 2 of Regulation (EU) 2017/745) and that relating to changes introduced by Regulation (EU) 2023/607.
Per register systems and procedural kits it is necessary to indicate the information required by Regulation (EU) 2017/745 and, in the case of systems and procedural kits sterilized before being placed on the market (art. 22, paragraph 3), also insert the relevant certificate issued by the Notified Body.
For devices certified in accordance with the directives, the validity of CE certificates will be determined on the basis of the indications of Regulation (EU) 2023/607 and the expiry date of the certificates will be automatically updated by the system.
For class I CE marked medical devices pursuant to Directive 93/42/EEC, for which the conformity assessment procedure pursuant to Regulation (EU) 2017/745 requires the involvement of a Notified Body, the system will allow you to select different options, on the basis of which the final date for placing on the market Of the device.
All detailed operational information is present on the system home page.
See also the section: National database of medical devices