MedTechLabel WP2 T1.1 Information Model Guide
0.4.3 - ci-build
MedTechLabel WP2 T1.1 Information Model Guide
0.4.3 - ci-build
MedTechLabel WP2 T1.1 Information Model Guide, published by HL7 Europe. This guide is not an authorized publication; it is the continuous build for version 0.4.3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/medtechlabel-wp2-im/ and changes regularly. See the Directory of published versions
| Official URL: http://www.hl7europe.org/medtechlabel/ImplementationGuide/medtechlabel | Version: 0.4.3 | |||
| Draft as of 2026-09-25 | Computable Name: MedTechLabel | |||
This is the starting page for the MedTechLabel project Information Model Guide (IG) that collects the necessary information for creating the information model for medical devices. It allows for collecting the information in interlinked fragments thus reducing duplication and overhead while finding a suitable representation of the details depending on their characteristics.
The primary purpose is for now:
A medical device can be described in many ways:
This specification has to abstract from it in order to allow for providing all the ncessary details for a modelling.
Following some standards that may or may not be of relevance:
| Standard | Title | Status | Comment |
|---|---|---|---|
| ISO 639 | Code for individual languages and language groups | ||
| ISO 780 | Packaging — Distribution packaging — Graphical symbols for handling and storage of packages | ||
| ISO 3166 | Country codes | ||
| ISO 3864-1:2011 | ´Graphical symbols — Safety colours and safety signs — Part 1: Design principles for safety signs and safety markings | ||
| ISO 7000 | Graphical Symbols for use on Equipment, e.g. 1641 | ||
| ISO 7010:2019 | Graphical symbols — Safety colours and safety signs — Registered safety signs, e.g. M001, P001 | ||
| ISO 8601-1 | Date and time — Representations for information interchange — Part 1: Basic rules´ | ||
| ISO 9001:2015 | Quality Management Systems - Fundamentals and vocabulary | ||
| ISO 13485 | Medical devices — Quality management systems — Requirements for regulatory purposes | ||
| ISO 14617-2:2025 | Graphical symbols for diagrams - Part 2: Graphical symbols | ||
| ISO 14971 | Risk Management Process | ||
| ISO 15223 | Medical devices — Symbols to be used with information to be supplied by the manufacturer | ||
| ISO 20417:2026 | ´Medical devices — Information to be supplied by the manufacturer | to be included | used as pilot for analysis |
| ISO 22742:2010 | QR Code | ||
| ISO/IEC 62304 | Medical device software — Software life cycle processes | ||
| ISO 62366 | |||
| FDA 21 CFR Part 820 | |||
| EMDN | European Medical Device Nomenclature | ||
| BS EN 1041:2008 | requirements for information to be supplied by a manufacturer for medical devices | outdated | Replaced by newer rules like ISO 20417 under modern EU medical regulations |
| MDD | Medical Device Directive | ||
| MDR | Medical Device Regulation | ||
| IVDR | Implantable Devices | ||
| IMDRF | International Medical Device Regulators Forum |