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Clinical Evaluation Reports (CERs)

  • 1.  Clinical Evaluation Reports (CERs)

    Posted 10-Mar-2015 10:28

    Those who work with Medical Devices are familiar with EU Annex I, Essential Requirements stating: "Demonstration of conformity with the Essential Requirements must include a clinical evaluation in accordance with Annex X".

    Real Regulatory has substantial and recent experience of authoring and updating CERs for a wide variety of Medical Devices in all Classes. Contact Karen Real ( to find out how we can assist you.

    See the guidance under:

    Karen Real
    Real Regulatory Ltd
    United Kingdom