Part A: Information to be submitted upon the registration of devices and economic operators in accordance with articles 29(4) and 31
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
1.1. type of economic operator(manufacturer, authorised representative, or importer),
1.2. name, address and contact details of the economic operator,
1.3. 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,
1.4. 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 is to or has been placed on the market in the Union,
2.4. in the case of class IIa, class IIb or class III devices: Member States where the device is or is to be made available,
2.5. risk class of the device,
2.6. reprocessed single-use device (y/n),
2.7. presence of a substance which, if used separately, may be considered to be a medicinal product and name of that substance,
2.8. presence of a substance which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma and name of this substance,
2.9. presence of tissues or cells of human origin, or their derivatives (y/n),
2.10. presence of tissues or cells of animal origin, or their derivatives, as referred to in Regulation (EU) No 722/2012 (y/n),
2.11. where applicable, the single identification number of the clinical investigation or investigations conducted in relation to the device or a link to the clinical investigation registration in the electronic system on clinical investigations,
2.12. in the case of devices listed in Annex XVI, specification as to whether the intended purpose of the device is other than a medical purpose,
2.13. in the case of devices designed and manufactured by another legal or natural person as referred in Article 10(15), the name, address and contact details of that legal or natural person,
2.14. in the case of class III or implantable devices, the summary of safety and clinical performance,
2.15. status of the device (on the market, no longer placed on the market, recalled, field safety corrective action initiated).