Healthcare professionals will now be able to receive instructions for use of medical devices in electronic format, rather than just on paper, under a European Commission regulation adopted on Wednesday 25 June (see EUROPE 13651/10). This implementing regulation applies to all medical devices used by healthcare professionals in the EU. However, they will still be able to request a paper version if they wish.
The adoption of electronic instructions is part of a wider Commission initiative to modernise healthcare systems, promote environmental sustainability and reduce the financial and administrative burden on device manufacturers.
In the coming days, the Commission will adopt a decision aimed at establishing a group of experts tasked with providing scientific and clinical advice regarding devices intended for certain patient populations, such as children or people with rare diseases.
The Commission is planning a review of the legislation for Medical Devices and In Vitro Diagnostics to ensure a safe supply of reliable devices for patients.
The measures will be presented in December by Commissioner Olivér Várhelyi. (Original version in French by Lionel Changeur)