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Regulation of medical devices

Common aspects of device regulations

Resources for medical device and in vitro diagnostic medical device regulations.

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In Vitro Diagnostics Regulation

Information specific to in vitro diagnostics medical device regulations only.

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Fees for medical devices

What we charge fees for and how to pay them.

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Documents and guidance

Links to national guidance documents, EU resources, webinars and other information on medical device and IVD regulations.

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Medical Device Regulation (MDR)

Information specific to medical device regulations only.

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Registration

How to register your organisation and device details.

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Legislation

Collection of links for laws governing the regulation of medical devices.

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