Guidance and policy

This section provides links to guidance and policy related to the regulation of medical devices.


 

How does a manufacturer comply with requirements?

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Conformity assessment 

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Registration of medical devices

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Other borderlines 

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Details of harmonised standards under the medical devices directives

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Medical devices classification 

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Notified bodies 

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Borderline with medicines

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Standards and common technical specifications 

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Page last modified: 06 January 2012