Part A: Information to be submitted upon the registration of devices and economic operators in accordance with articles 26(3) and 28
Manufacturers or, when applicable, authorised representatives, and, when applicable, importers shall submit the information referred to in Section 1 and shall ensure that the information on their devices referred to in Section 2 is complete, correct and updated by the relevant party.
1. Information relating to the economic operator
type of economic operator (manufacturer, authorised representative, or importer),
name, address and contact details of the economic operator,
where submission of information is carried out by another person on behalf of any of the economic operators mentioned under Section 1.1, the name, address and contact details of that person,
name address and contact details of the person or persons responsible for regulatory compliance referred to in Article 15,
2. Information relating to the device
2.1. Basic UDI-DI,
2.2. type, number and expiry date of the certificate issued by the notified body and the name or identification number of that notified body and the link to the information that appears on the certificate and was entered by the notified body in the electronic system on notified bodies and certificates,
2.3. Member State in which the device shall or has been placed on the market in the Union,
2.4. in the case of class B, class C or class D devices: Member States where the device is or is to be made available,
2.5. presence of tissues, cells, or, their derivatives, of human origin (y/n),
2.6. presence of tissues, cells or their derivatives of animal origin as referred to in Regulation (EU) No 722/2012(y/n),
2.7. presence of cells or substances of microbial origin (y/n),
2.8. risk class of the device,
2.9. where applicable, the single identification number of the performance study,
2.10. in the case of devices designed and manufactured by another legal or natural person as referred in Article 10(14), the name, address and contact details of that legal or natural person,
2.11. in the case of class C or D devices, the summary of safety and performance,
2.12. status of the device (on the market, no longer placed on the market, recalled, field safety corrective Action initiated),
2.13. indication as to whether the device is a ‘new’ device.
A device shall be considered to be ‘new’ if:
(a) there has been no such device continuously available on the Union market during the previous three years for the relevant analyte or other parameter;
(b) the procedure involves analytical technology not continuously used in connection with a given analyte or other parameter on the Union market during the previous three years.
2.14. indication as to whether the device is intended for self-testing or near-patient testing.