European Union: official sources for intended purpose and medical-device frameworks

Reviewed 13 October 2026. This guide covers selected official sources for medical devices and in vitro diagnostic medical devices. It does not cover every health-product framework and does not classify or authorise an individual product.

Record the use for which the product is intended according to the information supplied by the manufacturer, including the product configuration, users, setting, medical or non-medical function and any software or accessory needed. Separate materially different functions.

The official texts are Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. Use the current consolidated text and check amendments and transitional provisions relevant to the date and product.

The European Commission's MDCG endorsed documents and other guidance page groups current material on borderline and classification, IVDs, software, clinical evidence, post-market surveillance and other subjects. The Commission explains that most documents are not legally binding; they present a common understanding of practical application and are revised or archived over time.

For a classification question, begin with the applicable regulation and current borderline or classification guidance. For software, read the current software qualification and classification guidance. For an IVD, check the IVDR definition, intended purpose, qualification and classification sources. Do not apply an MDR or IVDR term to nutrition products or another category merely because the product is health-related.

Recheck the live legislation and Commission guidance before use. IAHPM's summary is an orientation aid, not an official interpretation or conformity decision.