EU Commission approves use of electronic instructions for certain medical devices

The Commission of the European Union (EU) has approved the use of electronic forms of instructions with certain medical devices intended for use exclusively by medical professionals.

Under the terms of a Commission Regulation issued in March 2012 and published in the Official Journal of the European Union, manufacturers of active implantable medical devices, implantable medical devices, fixed installed medical devices and medical devices fitted with visual display systems will be able to provide in electronic form use instructions previously provided on paper. Such devices are intended for use exclusively by medical professionals, and not by consumers.

Manufacturers opting to provide electronic instructions will be required to include notices on product packaging on how to access the electronic forms of instruction, or provide supplementary printed instructions on how to access electronic instructions.

Read the Regulation regarding the use of electronic instructions that applies as of March 1, 2013.