eIFU glossary

eIFU terminology explained

Plain-language definitions of the terms, regulations and standards used in electronic Instructions for Use for medical devices and in vitro diagnostics, from Regulation (EU) 2021/2226 to audit trails and paper copy obligations.

eIFU basics EU regulation Global regulation Quality and validation Platform operations

eIFU basics

eIFU: eIFU stands for electronic Instructions for Use: the regulated online publication of instructions for use and related labelling for medical devices and in vitro diagnostics, instead of supplying them on paper in the device packaging. The electronic documents must stay version-controlled, available in the required languages, and obtainable on paper on request.
IFU: Instructions for Use is the information supplied by a manufacturer to tell the user how a device is to be used safely and for its intended purpose, including warnings, precautions, and residual risks. It is part of the device labelling and is assessed during conformity assessment.
eIFU website: An eIFU website is the manufacturer-controlled website where electronic Instructions for Use are published. It must let users find the correct document for their device version and language, remain available without registration or payment, keep superseded versions accessible, and explain how to request a free paper copy.

EU regulation

EU 2021/2226: Commission Implementing Regulation (EU) 2021/2226 lays down the rules for supplying Instructions for Use electronically under Regulation (EU) 2017/745. It defines which device categories qualify, the risk assessment required, the website conditions, and the obligation to provide a paper copy free of charge on request within a defined period.
EU MDR 2017/745: Regulation (EU) 2017/745 is the European Union regulation governing medical devices. It sets the general safety and performance requirements, including the information that must accompany a device, and it is the legal basis under which Commission Implementing Regulation (EU) 2021/2226 permits electronic Instructions for Use.
EU IVDR 2017/746: Regulation (EU) 2017/746 governs in vitro diagnostic medical devices in the European Union. It allows Instructions for Use to be supplied by means other than paper for devices intended for professional use, subject to conditions on availability, language, and supplying a paper copy on request.
EU 207/2012: Commission Regulation (EU) No 207/2012 was the earlier European rule on electronic instructions for use of medical devices under the Medical Devices Directives. It has been superseded for devices placed on the market under Regulation (EU) 2017/745 by Commission Implementing Regulation (EU) 2021/2226.

Global regulation

SFDA MDS-G41: SFDA MDS-G41 is the Saudi Food and Drug Authority guidance on requirements for electronic Instructions for Use of medical devices. It sets expectations for website availability, language coverage, and paper copy provision for devices marketed in Saudi Arabia.
FDA 21 CFR Part 11: FDA 21 CFR Part 11 sets the United States requirements for electronic records and electronic signatures, covering audit trails, record integrity, access control, and system validation. Software used in regulated processes is described as Compliance Capable when it provides the controls a manufacturer needs to meet these requirements.
TGA eIFU guidance: The Therapeutic Goods Administration guidance on electronic Instructions for Use describes when Australian sponsors may supply instructions electronically, the information the eIFU website must present, and the obligation to make a paper copy available on request.

Quality and validation

ISO 13485:2016: ISO 13485:2016 is the international standard for quality management systems for organisations involved in the medical device life cycle. Certification demonstrates that documented processes, records, and controls are in place. IFUcare operates under an ISO 13485:2016 certified quality management system.
ISO 27001:2022: ISO 27001:2022 is the international standard for information security management systems. It requires a risk-based set of security controls covering access management, monitoring, incident response, and business continuity. IFUcare holds ISO 27001:2022 certification for information security.
IEC 62304: IEC 62304 defines the software life cycle processes for medical device software, covering planning, requirements, architecture, verification, release, and maintenance including problem resolution. IFUcare is developed under a software development life cycle in line with IEC 62304.
Computer system validation: Computer system validation is the documented evidence that a computerised system consistently performs its intended use within a regulated process. For an eIFU platform this typically covers requirements specification, risk assessment, installation and operational testing, and periodic review. The manufacturer remains responsible for its own validation activities.

Platform operations

Audit trail: An audit trail is the time-stamped, non-editable record of actions performed in a system: who uploaded, published, replaced, or withdrew a document, and when. For eIFU it evidences that the correct document version was available to users during a given period, which is what auditors and notified bodies ask to see.
Version history: Version history is the retained set of all published revisions of a document, including superseded ones. Electronic Instructions for Use must remain retrievable for the period required by the applicable regulation, so users of older device versions can still access the instructions that apply to their device.
Paper copy on request: Users must be able to obtain the Instructions for Use on paper free of charge, within the timeframe set by the applicable regulation. IFUcare fulfils this with a 24/7 multilingual freephone service and an online request form, with fulfilment tracked under service level agreement inside the IFUcare quality system.
UDI: Unique Device Identification is the system of codes that identifies a device and its production data. On an eIFU website the UDI or device identifier is commonly used as the search key so a user can retrieve exactly the Instructions for Use that apply to the device in front of them.
Role-based access control: Role-based access control restricts what each user may do based on an assigned role, such as author, approver, or administrator. In eIFU management it separates who may upload a document from who may approve and publish it, giving the segregation of duties expected in a regulated quality system.
Notified body: A notified body is an organisation designated by an EU member state to assess whether a manufacturer and its devices conform to the applicable regulation before CE marking. Notified bodies review labelling decisions, including the risk assessment and controls behind supplying Instructions for Use electronically.

Looking for the underlying legal texts? The regulatory references list the official regulations, guidance documents and standards per region.