Electronic Age: UK MHRA Issue Guidance On eIFU Requirements

The EU regulation on electronic Instructions for Use (IFU) (Regulation 207/2012) came into force on March 1^st 2013. In response to the implementation of electronic IFUs, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a guidance document to provide device manufacturers with an overview of requirements described in Regulation 207/2012.

The Regulation defines IFU as information provided by the manufacturer to inform the user of the device of its safe and proper use, of its intended performances and of any precautions to be taken as outlined in the Directives 93/42/EEC and 90/385/EEC.

Key requirements for manufacturers include the following:

• Applicability; only some device types are able to provide electronic IFU.
• Conditions that apply
• Risk assessment must be conducted
• Electronic labelling requirements
• Website provision

KD&A can assist your organisation to complete activities required to ensure Regulation 207/2012 compliance. Contact us for a personalised quotation.