Europe – MDCG 2021-11 Guidance on Implant Card – ‘Device types’

According to Article 18 (a) of the MDR, the manufacturer of an implantable medical device
shall provide together with the device, information allowing the identification of the
device, including the device name, serial number, lot number, the UDI, the device model, as well as the name, address and the website of the manufacturer. In accordance with the instructions laid out in MDCG 2019-8, the implant card should also indicate a ‘device type’ for the implantable medical device in question (see in red below)…