Guidance
Electronic instructions for medical devices
How manufacturers can comply with the regulations when providing instructions for using medical devices in an electronic form.
Documents
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
Updates to this page
Published 14 March 2013