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 (kreal@realregulatory.com) to find out how we can assist you.
See the guidance under: http://ec.europa.eu/health/medical-devices/files/meddev/2_7_1rev_3_en.pdf
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Karen Real
Director
Real Regulatory Ltd
London
United Kingdom
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