Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, an advisor to MedTech suppliers, chair of the Urology Trade Association, and governor of the Anscombe Bioethics Centre, reports on European Union plans to digitise access to instructions for the use of medical devices.
Healthcare professionals will be able to receive instructions for use of medical devices in electronic format, rather than solely on paper, following presentation of a new regulation by the European Commission.
The regulation applies to all medical devices used by healthcare professionals within the EU. Professionals can still request paper versions if preferred. The adoption of electronic instructions for use is a part of the Commission’s broader initiative to modernise healthcare, support environmental sustainability, and alleviate financial and administrative pressures on device manufacturers. The measure was broadly supported in recent consultations of the European Commission with professionals and industry representatives.
The announcement is part of the Commission’s ongoing work to streamline and improve the EU’s rules for medical devices. The Commission is also expected to announce the establishment of a new expert panel to provide scientific and clinical advice about devices intended for small patient populations, such as children or patients with a rare disease.
The Commission is also continuing its evaluation of the regulatory framework, with a view to a revision of the legislation for Medical Devices and In Vitro Diagnostics, to “reduce unnecessary burdens and make the requirements more cost-efficient and proportionate”. The evaluation and its follow up actions will be presented in December, when EU Health Commissioner Olivér Várhelyi will host a conference on medical devices in Brussels.
The Author used AI in preparing this article, comments upon or questions about which can be addressed to chris.whitehouse@whitehousecomms.com.
