EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
IVDR - Identification + UDI + Registration + EUDAMED (Ch III)

EU In Vitro Diagnostic Medical Devices Regulation (IVDR) IVDR-Art.26_27_28: Registration of devices and economic operators (Articles 26-28)

What does IVDR-Art.26_27_28 require?

Article 26 requires registration of devices: before placing a device on the market or putting it into service, the manufacturer (other than custom-made or investigational devices) registers the device, the manufacturer and the UDI-DI in EUDAMED. Article 27 establishes the electronic registration system for economic operators. Article 28 requires manufacturers + authorised representatives + importers to register their data (identity + authorised activities + EU economic-operator identification number) in EUDAMED. The data is publicly accessible (with limited carve-outs for confidential information).

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

What else in your programme already covers this

This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

  • MDR-Art.29_30_31 Registration of devices and economic operators (Articles 29-31)

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in IVDR - Identification + UDI + Registration + EUDAMED (Ch III)

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