In March 2012, the European Commission published Commission Regulation (EU) No 207/2012 on electronic Instructions For Use (eIFU) of medical devices.. This is commonly referred to as the e-labelling Regulation. The Regulation will apply from 1st March 2013, after which time medical device manufacturers can choose to provide IFU’s by electronic means for certain general and active implantable medical devices.
Devices Permitted to have an eIFU
The Regulation establishes the conditions under which IFU’s for certain categories of medical devices may be provided in electronic format, instead of a paper IFU as is currently required by the legislation governing general medical devices and active implantable medical devices. The Regulation covers electronic IFU’s which are: (1) displayed in electronic form by the device, (2) contained in portable electronic storage media supplied by the manufacturer with the device, and (3) IFU’s provided through a website. Article 3 of the Regulation outlines the types of medical devices for which manufacturers may supply the IFU electronically. However, the devices and accessories must be intended for use only by professional users, and the manufacturer must be confident that the use of such devices by other persons is not reasonably foreseeable. The devices for which eIFUs are permitted are shown in Table 1.
Requirement to Conduct a Risk Assessment
Manufacturers who wish to provide IFU in electronic form instead of a paper IFU are required under Article 4 of the Regulation to undertake a documented risk assessment to demonstrate that providing instructions for use in electronic form maintains or improves the level of safety obtained by providing the instructions for use as a paper IFU. The main elements that the risk assessment should address are outlined in the Regulation.
In addition, the Regulation outlines that:
- the manufacturer must provide a copy of the paper IFU if requested by the user. The paper form must be provided within seven calendar days (or sooner if required by the risk assessment) of receiving a request from the user or at the time of delivery of the device if requested at the time of the order.
- the manufacturer shall provide either on the device or on an accompanying leaflet, information on foreseeable medical emergency situations and, for
- devices fitted with a built-in system visually displaying the IFU, information on how to start the device must be provided.
- for medical devices fitted with a built-in system visually displaying the IFU, the manufacturer shall ensure that displaying the instructions for use does not impede the safe use of the device, in particular life-monitoring or life supporting functions.
- a system must be in place to clearly indicate if the IFU’s have been revised and if the revision was necessary for safety reasons.
- for devices with a defined expiry date, except implantable devices, they shall keep the IFU available for the users in electronic form for at least 2 years after the end of the expiry date of the last produced device.
- for devices without a defined expiry date and for implantable devices, they shall keep the IFU available for the users in electronic form for a period of 15 years after the last device has been manufactured.
- the manufacturer must provide appropriate information about how to access the e-IFU and about the right to request the paper IFU.
- The e-IFU shall be available as text which may contain symbols and graphics with at least the same information as the paper IFU. Video or audio files may be offered in addition to the text.
- the notified body certifying the medical device should review the e-IFU based on a specific sampling method for all but Class I devices.
- manufacturers who provide e-IFU must indicate on their website in which EU languages those instructions are available.