The European Commission has published draft regulation covering electronic instructions for use in the European Union that would affect both device medical device manufacturers and notified bodies.

Although any finalization date for the regulation remains unknown, The EU Regulatory Committee on Medical Devices is expected to consider the draft document in late September, according to BSI.

The draft regulation specifies which medical devices qualify for electronic instructions for use in lieu of manual instructions:

• Active implantable medical devices and accessories covered by Directive 90/385/EEC
• Implantable devices and accessories as well as fixed installed devices covered by Directive 93/42/EEC
• Medical devices and accessories fitted with built-in capabilities to display instructions for use and covered by Directives 90/385/EEC and 93/42/EEC
• Stand-alone software covered by Directive 93/42/EEC

Furthermore, manufacturers of the devices listed above may issue electronic instructions for use only if those devices are intended for use only by professionals, the regulation stipulates.

Manufacturers of qualifying medical devices must also conduct risk assessments to account for the knowledge and experience of intended professional users of their products, the environment in which their products will be used, as well as users’ knowledge and experience regarding any hardware and software required to display electronic instructions for use. Manufacturers would also have to assess electronic data safeguards as well as hardware and software safety and backup mechanisms. Risk assessments would also have to be updated based on post-market experience and data.

Providing electronic instructions for use would also be contingent upon several conditions, including:

• Risk assessments must show that electronic instructions for use maintain or improve the device’s safety level
• Electronic instructions for use must be made available in all EU member states where the device is sold or used
• Instructions for use in paper format must be provided to users upon request
• Information regarding foreseeable medical emergency situations
• Manufacturers must provide verification and validation evidence that electronic instructions for use are designed and function properly

With the exception of Class I medical devices defined in Annex IX of Directive 93/42/EEC, the draft regulation would obligate notified bodies to review manufacturers’ compliance with all requirements during conformity assessments using sampling methods appropriate for particular devices’ class and complexity.