Regulation (EU) 2017/746 of the European Parliament and of the CouncilShow full title

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.