Online instruction for use & compliance
Electronic Instruction for Use for
Healthcare Devices
The European Union Regulation EU 2021/2226, amended by EU 2025/1234, provides a framework for delivering electronic instructions for use (eIFU). This framework can be a solid foundation for showcasing compliance to Medical Device Regulation EU 2017/745, In Vitro Diagnostic Medical Devices EU 2017/746, FDA or TGA.
As your partner,
Activem helps you ensure full compliance to EU 2021/2226
Activem supports manufacturers' compliance by hosting the IFUs on a website, managing the eIFUs updates and archives, and delivering copies of the IFUs to clients upon request. Our services include providing traceable evidence of our process, such as risk assessment, verification, and validation documents which can be integrated into a manufacturer’s Quality Management System.
How does Activem comply to each article?
Article 1
Activem supports manufacturers in providing solutions for the application of EU 2021/2226.
Article 2
Activem enables manufacturers to deliver Instructions for Use (IFUs) electronically through a website accessible to all intended users. This site can be reached via a hyperlink from the manufacturer’s website or through a dedicated URL.
Article 3
Activem supports manufacturers in delivering eIFUs for their designated medical devices and intended users.
Article 4
Activem supports manufacturers in the eIFU process by providing a comprehensive, documented risk assessment that includes risk control measures for user knowledge and environment, technical access and data security, emergency preparedness (including archiving, paper alternatives, and internet outages), device compatibility, and version management. This assessment is continuously updated based on post-market feedback.
Article 5
Activem provides verification and validation documentation for every new IFU upload. eIFUs can be viewed, downloaded, or printed by users on any device with a modern browser. Older versions are securely archived and made available upon request. Paper copies can be delivered via express courier. Registered users are notified by email when new updates are available. All archived IFUs remain accessible for 15 years.
Article 6
Activem supports manufacturers in implementing eIFUs with checklist guidance for device labeling and ISO 15223-1 compliance symbols. We provide a dedicated eIFU URL that can be linked from the manufacturer’s website. Activem also enhances eIFUs with multilingual content, video, audio, or text-to-speech features, based on manufacturer-provided materials.
Article 7
Activem makes eIFUs accessible for viewing, downloading, or printing on any device with a modern browser. All eIFUs are globally accessible and hosted on Amazon Web Services (AWS) infrastructure, with a 99.9% availability commitment through Service Level Agreements. Each upload automatically triggers a backup to Amazon S3. Previous versions are securely archived and available upon request, with archives retained for 15 years