Glossary · EU medical devices: MDR
Labeling and instructions for use (MDR and IVDR)
Also known as: Information supplied with the device, Label and IFU (MDR), Electronic instructions for use (eIFU)
Under the EU Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, the label and the instructions for use are the information supplied by the manufacturer with the device, as set out in Annex I Chapter III (Section 23 MDR, Section 20 IVDR). The label identifies the device and manufacturer and carries safety-relevant information; the instructions for use tell the user how to use the device safely and as intended.
- EU
- MDR
- IVDR
- Technical documentation
In one sentence
Label and IFU requirements under MDR Annex I Section 23 and IVDR Annex I Section 20: the information that must accompany a medical device or IVD.
Example
A manufacturer of a sterile single-use catheter lists on its label the device name, manufacturer, UDI carrier, lot number, expiry date, sterilization method and the single-use symbol from ISO 15223-1, and supplies eIFU to hospital users under Implementing Regulation (EU) 2021/2226.
Explained in context
Context cards connect this term with others to answer one question. Also in British English and German.
How it applies
- Label: Device name, manufacturer and, where applicable, authorized representative and importer, the UDI carrier, lot or serial number, use-by date, sterile state, storage conditions, warnings and a statement that the product is a medical device.
- Instructions for use: Intended purpose, indications, contraindications, target groups, residual risks, warnings and precautions, installation, maintenance and disposal information. Annex I allows some class I and IIa devices to be supplied without IFU where they can be used safely without them.
- Symbols and structure: ISO 15223-1 supplies the symbols; ISO 20417 the general requirements for information supplied by the manufacturer.
- Language: The information must be in the official language or languages determined by the member state where the device is made available. Devices for lay users need wording they can understand.
- Electronic IFU: Implementing Regulation (EU) 2021/2226 sets when medical devices may be supplied with instructions in electronic form instead of paper, mainly for professional users.
- Technical documentation: Label and IFU are part of the Annex II technical documentation. Their content must match the risk management file, the clinical or performance evaluation and the SSCP.
MDR IFU vs. machinery information for use
The MDR and IVDR IFU is a regulated set of content items defined by Annex I Chapter III and tied to the device’s intended purpose and residual risks. The general instructions for use concept in machinery and product safety has its own legal source and structure. A device that is also a machine or radio equipment has to satisfy each applicable set of requirements; one does not replace the other.