Transcription of Essential Requirements Checklist - Medical Device Academy
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Essential Requirements Checklist - Medical Device Academy
Essential Requirements Checklist Annex I of Proposed EU regulations & Compromise Amendment for Medical Device CE Marking Identity of the Device and applicable configurations/variants covered by this Checklist : Template Created by Jennifer Cardinal on 9- 30- 2013 (redlines represent changes in compromise amendment) Essential Requirements Applicable to the Device ? Method Used to Demonstrate Conformity Method Reference Reference to Supporting Controlled Documents I. General Requirements 1 devices shall achieve the performance intended by the manufacturer and be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose, taking into account the generally acknowledged state of the art. They shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.
category 1A or 1B in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008, these devices shall be labeled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as devices containing phthalates. If the intended use of such devices includes treatment of children or treatment of
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