The European Commission has published the list of requirements under the MDR that was prepared by the UK MHRA.
14-pager presents exhaustive list of obligations for economic operators, while placing particular focus on manufacturers regarding:
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General systems and process requirements
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Conformity assessment and CE marking
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Provisions concerning specific devices types/activities
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Requirements relating to UDI
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Compliance with common specifications and harmonised standards
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Clinical evaluation and clinical investigations
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Post-market surveillance and vigilance
You can find other useful documents here, which will help you better understand the new Regulation.
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