Labelling requirements
Regulatory basis - MDR Annex I §23 / IVDR Annex I §20 (GSPR labelling requirements); MDR Art. 10(11) (labelling obligations on manufacturers). Language requirements vary by member state. Post-market labelling obligations extend to maintaining current labelling as the device and evidence evolve.
Disclaimer - This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and a qualified regulatory professional.
Labelling as a post-market obligation
Labelling is often treated as a pre-market task — something finalised before CE marking. Under MDR/IVDR, labelling is also a post-market obligation: the manufacturer must maintain labelling that accurately reflects the current state of knowledge about the device, including post-market evidence and identified risks.
The IFU must be updated when:
- New risks or contraindications are identified through PMS or vigilance
- PMCF/PMPF data reveals new clinical information
- Usability issues identified post-market require IFU improvements
- Regulatory requirements change (new GSPR application, new CS)
- The device is modified
Label requirements — summary
The device label must include the following (per MDR Annex I §23.2):
| Required element | Notes |
|---|---|
| Manufacturer name and address | Full legal name and registered address |
| EU REP name and address | For non-EU manufacturers |
| UDI carrier (barcode/DataMatrix) | UDI-DI + applicable UDI-PI |
| Lot or batch number | Preceded by "LOT" symbol |
| Serial number | Preceded by "SN" symbol (where applicable) |
| Manufacturing date | Where not apparent from lot number |
| Expiry date | "Use by" date where applicable |
| Sterile designation | Using the STERILE symbol; method-specific variants |
| Single-use designation | Using the single-use symbol with maximum reuses if applicable |
| Quantity | Number of devices in the package |
| Conditions for storage/handling | Temperature, humidity, pressure limits |
| Warnings or precautions requiring immediate user attention | Only those needing prominence on label |
| Intended purpose (if not obvious) | Brief statement where needed |
| CE mark | With NB number where applicable |
| Importer name and address | For imported devices |
For IVDs (IVDR Annex I §20.2), additionally:
- Intended analyte(s)
- Type of specimen(s) required
- Any reagent hazard information
- Whether for self-testing or near-patient use
IFU requirements — post-market maintenance
The IFU is the primary vehicle for communicating device-specific safety information to users. Post-market obligations require it to remain current.
Triggers for IFU update:
| Trigger | Required update |
|---|---|
| New safety signal from PMS | Add or strengthen warnings, contraindications, or precautions |
| PMCF reveals new population risk | Update patient selection guidance in IFU |
| Usability issues identified | Improve instruction clarity, add diagrams |
| New contraindicated combinations | Add to contraindications section |
| New adverse event identified | Add to risks/side effects section |
| Regulatory standard revision | Update to reflect new harmonised standard requirements |
When the IFU is updated, the change must be:
- Documented under change control
- Assessed for whether the change constitutes a significant change (MDCG 2020-3)
- Communicated to customers (and to the NCA if safety-related and material)
- Reflected in the technical documentation
Language requirements
Labels and IFUs must be in the official language(s) of each member state where the device is marketed. This is a per-market requirement — not an EU-wide single language.
Practical implications:
- A device sold in Germany, France, and Spain requires labels and IFUs in German, French, and Spanish
- Multi-language documents are permitted — many manufacturers produce pan-EU documents covering all official EU languages
- Symbols can reduce the text translation burden (but symbols must themselves be standardised and recognisable)
- eIFU rules allow electronic IFU to reduce the physical label burden — see Electronic IFU (eIFU)
Symbols in labelling
Symbols must be from recognised standards — primarily EN ISO 15223-1 (Symbols to be used with medical devices). Non-standardised symbols must be explained on the label or packaging. All symbols must be reproduced accurately and legibly.
NCAs enforce labelling requirements during market surveillance inspections. Non-compliant labels (missing UDI, wrong symbols, incorrect language) are among the most common market surveillance findings.
Related pages
- GSPR Chapter III — IFU & labelling
- UDI labelling requirements
- Advertising rules
- Permitted & prohibited claims
Official references
| Reference | Description |
|---|---|
| MDR Annex I §23 | Labelling and IFU requirements |
| IVDR Annex I §20 | IVDR labelling and IFU |
| EN ISO 15223-1:2021 | Symbols for medical device labelling |
| Commission Regulation (EU) 207/2012 | eIFU rules |
| MDCG 2019-16 | IFU content guidance |
| MDCG 2020-3 | Significant change assessment (relevant for labelling updates) |