EU Medical Devices Regulation (MDR 2017/745)
MDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X)

EU Medical Devices Regulation (MDR 2017/745) MDR-Art.83: Post-market surveillance system of the manufacturer (Article 83)

Article 83 requires manufacturers to plan + establish + document + implement + maintain + update a post-market surveillance (PMS) system, proportionate to the risk class and appropriate for the type of device. The PMS system actively + systematically gathers, records and analyses data on the quality, performance and safety of the device throughout its entire lifetime; the PMS plan is part of the technical documentation (Annex III). PMS information feeds back into clinical evaluation (Article 61), vigilance (Articles 87-92), the SSCP (Article 32) and the PSUR (Article 86).

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

What else in your programme already covers this

This control maps to 2 controls across 2 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

  • IVDR-Art.78 Post-market surveillance plan and system (Article 78)

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 MDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X)

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The graph holds this control, the 2 it maps to, and the evidence behind each claim, over MCP and REST.