Guidance

Electronic instructions for medical devices

Guidance for medical device manufacturers on when to use electronic instructions and how to comply with the regulations.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 14 March 2013

Documents

Guidance on the regulations for electronic instructions for use of medical devices

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Details

This guidance provides information on:

• definitions included in the Medical Device Regulations 2002 (as amended)
• types of device the regulations apply to
• conditions
• risk assessment
• requirements for the electronic labelling
• website provision
• UK approved bodies and notified bodies

Published 14 March 2013