MDCG 2021-11 – Guidance on Implant Card “Device Types” ❔

The #MDCG has released a document regarding the information provided with an implantable device.  Per Article 18 (a) of the MDR, a manufacturer of implantable medical devices shall provide, together with the device, information allowing for the identification of the device, including device name, serial number, lot number, the UDI, the device model. They also must provide the name, address and the website of the manufacturer.

🔗 https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_2021-11_en.pdf