On 1 March 2013, the European Commission Regulation 207/2012 on 'electronic instructions for use of medical devices' came into force in the UK. The Regulation sets the conditions according to which instructions for use of a medical device in paper form may be replaced by an electronic substitute. The rationale for this change is to help reduce cost and environmental burdens whilst maintaining or improving levels of safety.
The provision of instructions in electronic form is limited to 'implantable' medical devices (e.g. pacemakers), 'fixed' devices that are intended to be installed at a specific location in a healthcare facility (e.g. X-ray machines), standalone software and medical devices fitted with a built in system visually displaying the instructions for use. Further, the Regulation only applies to medical devices used exclusively by persons in the course of their work and in the framework of a professional healthcare activity.
Manufacturers of such devices must undertake a risk assessment procedure covering, among other things, 'foreseeable medical emergency situations' and the 'impact caused by the temporary unavailability of the website'. Once they have demonstrated increased or maintained safety levels, manufacturers of qualifying devices may provide electronic instructions in all Member States where the product is made available. If the option to use electronic labelling is exercised a link to instructions on a website must always be provided, although various media (including memory sticks and CDs) may additionally be used. Instructions for use in printed form shall be provided free of charge within seven (7) calendar days of a request, and users must be made aware of their right to request these.
With regard to cost implications, a Eucomed consultant opines that, "Electronic instructions won't cost less, and might cost more, but the advantage in terms of better information for users is quite clear." The Regulations would make certain European markets more accessible to producers of medical devices by avoiding the need to print an instructional manual in that state's official language. The legislation is to be reviewed between 2016 - 2018. A successful experience with the e-labelling regime should reduce reticence among Member States and may lead to an increase in the range of devices to which these Regulations apply.