EU Medical Devices Regulation (MDR 2017/745)
MDR - Classification + Conformity Assessment (Ch V)

EU Medical Devices Regulation (MDR 2017/745) MDR-Art.56_57: Certificates of conformity and electronic system (Articles 56-57)

Article 56 governs certificates of conformity issued by NBs (validity max 5 years, may be subject to conditions, suspended/withdrawn/restricted on non-compliance). Certificates are technology-bound and may require periodic surveillance. Article 57 establishes the electronic system on NBs + certificates available through EUDAMED.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

Other controls in MDR - Classification + Conformity Assessment (Ch V)

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.