ANNEX XIICERTIFICATES ISSUED BY A NOTIFIED BODY

CHAPTER IGENERAL REQUIREMENTS

4.The scope of the certificates shall unambiguously identify the device or devices covered:

  1. (a)

    EU technical documentation assessment certificates, EU type-examination certificates and EU product verification certificates shall include a clear identification, including the name, model and type, of the device or devices, the intended purpose, as included by the manufacturer in the instructions for use and in relation to which the device has been assessed in the conformity assessment procedure, risk classification and the Basic UDI-DI as referred to in Article 27(6);

  2. (b)

    EU quality management system certificates and EU quality assurance certificates shall include the identification of the devices or groups of devices, the risk classification, and, for class IIb devices, the intended purpose.