EU Medical Devices Regulation (MDR 2017/745)
MDR - Identification, UDI, Registration and EUDAMED (Ch III)

EU Medical Devices Regulation (MDR 2017/745) MDR-Art.29_30_31: Registration of devices and economic operators (Articles 29-31)

What does MDR-Art.29_30_31 require?

Article 29 requires registration of devices in EUDAMED prior to placing on the market or putting into service: manufacturer registers device + UDI-DI + design information. Article 30 establishes the electronic system for registration of economic operators. Article 31 requires manufacturers + ARs + importers to register their data in EUDAMED (identity + activities + EU economic-operator identification number). Data is publicly accessible (with limited carve-outs).

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

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Other controls in MDR - Identification, UDI, Registration and EUDAMED (Ch III)

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