Electronic IFUs for EU MDD & AIMDD Devices

The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther:

The Commission Regulation of electronic instructions for use (IFUs) of Medical Devices 207/2012 was released 10 March 2012.  Here’s a general summary:

• The directive does not cover IVDD devices which have their own guidance document.
• In general, an e-IFU is allowed for:
• AIMDD and MDD devices intended exclusively for professional use where use by other persons is not reasonably foreseeable.
• MDD device fitted with a built-in system visually displaying the instructions for use.
• It is important to read the full requirements.  Below is a summary of some key items.
• A documented risk analysis is required covering at least the items listed in Article 4 of the e-IFU directive (intended users’ access to hardware and software to view the e-IFU, intended use environment and access to e-IFU at time of use, etc.).  BSI provided a link, e-IFU REGULATION RISK ASSESSMENT SURVEY, to a general survey which may help avoid the need to run individual surveys.  As with all risk analyses, it must be updated based on experience from the post-marketing phase.
• Information on foreseeable medical emergency situations and, for devices fitted with a built-in system visually displaying the instructions for use, information on how to start the device must be provided with the device.  The information may be on the device or on a leaflet sent with the device.
• Instructions must remain available:
• For 2 years after the expiry date of the last produced device.
• For 15 years after the last device has been manufactured for:
• Devices without an expiry date.
• Implantable devices.
• There are specific requirements when the e-IFU is available through a website such as server downtime and display errors must be reduced as far as possible, and access must meet directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data. 
• Hardcopy of the IFU must be provided no later than 7 days from request and at no charge to the user.
• As of March 2013, the Notified Body will need to review compliance (with the exception of Class I MDD devices).

Additional requirements may apply to specific devices based on relevant standards.  For example, from EN 60601-1:2006 (same as IEC 60601-1:2005):

• For medical devices, clause 7.9.1 states, “ACCOMPANYING DOCUMENTS may be provided electronically, e.g. electronic file format on CDROM.  If the ACCOMPANYING DOCUMENTS are provided electronically, the RISK MANAGEMENT PROCESS shall include consideration of which information also needs to be provided as hard copy or as markings on the ME EQUIPMENT, e.g. to cover emergency operation.”
• For medical systems, clause 16.2 states, “NOTE ACCOMPANYING DOCUMENTS can be provided electronically, e.g. electronic file format or CD-ROM, for an ME SYSTEM capable of displaying or printing those documents.”