On June 8, 2011, the European Commission released for comments the draft regulation on electronic instructions for use. The final deadline to submit comments was August 8, and the EU Regulatory Committee on Medical Devices is scheduled to deliberate and consider the draft regulation at a meeting on September 20, 2011. The proposed date of adoption of the regulation is December 14, 2011, and the date of enforcement is one year later in order to facilitate the smooth transition to the new system and give all operators and member states sufficient time to adapt to it.
The regulation sets out conditions according to which instructions for use (IFU) may be provided in electronic form instead of paper form for professional users only. Although the definition of “instructions for use in electronic form” is IFUs that are either displayed in electronic form by the device, contained in a portable electronic storage media supplied with the device, or available through a Website, the draft regulation requests that IFUs should also be available through a Website.
IFUs have to be provided in paper form on request, and a specific risk assessment by the manufacturer and information on how to gain access to the IFUs are needed. This risk assessment should show that it maintains or improves the level of safety obtained by providing the IFUs in paper form, and should be updated in view of the experience gained in the post-marketing phase.
Except for Class I medical devices, as defined in Annex IX to Directive 93/42/EEC, the fulfillment of the requirements in the regulation should be reviewed by a notified body during its audit based on a specific sampling method. The other main points of the draft regulation include the following:
• In their catalogs or other appropriate device information support documents, medical device manufacturers shall provide information on software and hardware requirements needed to display the IFUs;
• Manufacturers shall have a system in place to indicate clearly when the IFUs have been revised and inform users of the device if the revision was necessary for safety reasons;
• For devices with a defined expiration date, manufacturers shall keep the IFUs available for users in electronic form for at least two years after the expiration date;
• For devices without a defined expiration date and for implantable devices, manufacturers shall keep the IFUs available for users in electronic form for fifteen years after the last device has been manufactured;
• Manufacturers shall clearly indicate on the packaging for each unit or on the sales packaging how to access the IFUs in electronic form, and inform users that they may request and obtain at no additional cost the IFUs in paper form at anytime;
• The information on how to access the IFUs in electronic form shall contain the following: any information needed to view the IFUs; a unique reference giving direct access and any other information needed by users to identify and access the appropriate IFUs; relevant manufacturer contact details; where, how, and within which timeframe IFUs in paper form can be obtained.
• Information via video or audio files may be offered in addition to the text.
The full text of the draft regulation on electronic instructions for use may be downloaded at ec.europa.eu/enterprise/tbt/tbt_repository/EEC381_EN_1_1.pdf.
Rene Clement is co-chairman of MediMark Europe, which serves as an authorized representative for U.S. manufacturers of medical devices and IVD products. For more information about the firm, visit the company's listing in the online Consultants Directory.