Streamlined Guidelines for Medical Devices Usage in Digital Healthcare by European Commission
The European Commission has announced a new regulation aimed at digitising access to instructions for the use of medical devices. This initiative is part of a broader effort to modernise healthcare, streamline regulatory compliance, and improve user access to instructions through digital means.
Key Details of the EU's Digitisation Plan
The plan involves making instructions for use (IFU) for medical devices available digitally, reducing reliance on paper-based leaflets. This digitalisation is linked to the ongoing implementation of the EU Medical Device Regulation (MDR) and the European database on medical devices (EUDAMED), where device information, including instructions, will be registered and accessible in digital formats such as XML files.
Starting from 2025 and continuing through 2026, phases of updates to regulatory databases (like EUDAMED) will require manufacturers to submit digital data for medical devices, including regulatory devices with CE marks.
Impact on Healthcare Professionals
The digitalisation of instructions for medical devices is expected to significantly improve access to up-to-date and accurate digital instructions for healthcare professionals. This will provide easily searchable, standardised, and current information at the point of care, enhancing patient safety and facilitating quicker decision-making by avoiding outdated paper leaflets.
Impact on Device Manufacturers
Manufacturers must adapt to these digital requirements by developing and submitting instructions in prescribed formats (e.g., XML) aligned with EUDAMED standards. This will involve investments in digital documentation and compliance systems but also reduces printing and distribution costs associated with paper instructions. The new system is expected to streamline regulatory submissions and post-market surveillance activities.
Environmental Impact
The digitalisation of instructions for medical devices will result in a significant reduction in paper use, lowering the environmental footprint related to printing, packaging, and logistics. Digitally accessible instructions mean less physical waste and support sustainability efforts within healthcare and manufacturing sectors.
The Commission's announcement was broadly supported in recent consultations with professionals and industry representatives. The adoption of electronic instructions for use is part of the Commission's broader initiative to modernise healthcare, with the aim of reducing unnecessary burdens and making the requirements more cost-efficient and proportionate.
Healthcare professionals can still request paper versions if preferred. The Commission will present the evaluation and its follow-up actions in December, with a conference on medical devices in Brussels hosted by EU Health Commissioner Olivér Várhelyi.
This information was published in "Digital Health & AI Insights" and was prepared using AI. For comments or questions about the AI used, please contact [email protected]. The new CEO's agenda prioritises patient safety and access to innovative products, and the Commission is expected to announce the establishment of a new expert panel to provide scientific and clinical advice about devices intended for small patient populations. Additionally, the UK Government is consulting on more draft Medical Devices Regulations.
- The new regulation from the European Commission, aimed at digitising access to medical device instructions, is part of a broader science-driven initiative to modernise healthcare and improve user access to health-and-wellness information by leveraging technology.
- The digitisation plan, which includes making instructions for use (IFU) for medical devices available digitally, will have a significant impact on device manufacturers, requiring them to invest in digital documentation and compliance systems to submit digital data in prescribed formats like XML, thus reducing printing and distribution costs associated with paper instructions.
- The digitalisation of medical device instructions is expected to not only provide healthcare professionals with easily searchable, standardised, and up-to-date information at the point of care, enhancing patient safety, but also contribute to environmental sustainability efforts, given the reduction in paper use associated with this change.
