GSPR Chapter III — Information supplied with the device
MDR 2017/745, Annex I, Chapter III, Section 23 and IVDR 2017/746, Annex I, Chapter III, Section 20. These are the labelling and IFU requirements as part of the GSPR. Post-market labelling obligations are covered separately in Labelling & advertising.
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.
What Chapter III requires
Chapter III of Annex I establishes the requirements for information supplied with devices, including:
- Labels — information on or attached to the device or its packaging
- Instructions for use (IFU) — directions for safe and effective use
- Symbols — standardised graphical symbols used in labelling
The guiding principle is that information must be clear, accurate, and sufficient to allow the intended users to use the device safely and achieve its intended performance.
Section 23 — MDR labelling requirements
MDR Annex I Section 23.2 specifies the information that must appear on the label (on the device, packaging, or outer packaging):
| Required element | Notes |
|---|---|
| Name and address of the manufacturer | Full legal entity name and registered address |
| UDI carrier (UDI-DI and UDI-PI) | Mandatory on all devices; format depends on class |
| Intended purpose | Where not obvious from the device itself |
| Lot/batch number or serial number | As applicable; lot for manufactured batches |
| Manufacturing date | If not apparent from lot number |
| Expiry date | If applicable — express as YYYY-MM-DD or YYYY-MM |
| "Sterile" designation | If device is sterile — standardised symbol |
| "Single use" designation | Using standardised symbol; with maximum number of reuses if applicable |
| Any conditions for storage/handling | Temperature range, humidity limits, etc. |
| For implantable devices: size, model, and serial number | Must appear on label |
| EU REP indication | Name and address of authorised representative (for non-EU manufacturers) |
| Importer information | Where applicable — name and address |
| Warnings or precautions | To be brought to immediate attention of user |
| For Class III devices: implant card reference | Reference to implant card where required |
Labels for IVDs (IVDR Annex I Section 20.2)
IVDR labels must additionally include:
- The intended analyte(s)
- The type of specimen required
- Specimen collection and storage requirements
- Expected values and measurement range
- Indication of whether the device is for self-testing or near-patient testing
Section 23 — MDR IFU requirements
The instructions for use (IFU) must contain all information needed to use the device safely and achieve its performance. MDR Annex I Section 23.4 requires the IFU to include (where applicable):
- Name, trade name, or trademark of the device
- Intended purpose (in detail)
- Device description and accessories
- Indications, contraindications, warnings, and precautions
- Instructions for use in each step — preparation, set-up, use, cleaning, disinfection, sterilisation (if reusable), disposal
- Residual risks, side effects, and undesirable effects
- Conditions for storage and handling
- Instructions for any required maintenance, repair, and calibration
- Information on any medicinal substance incorporated
- Electromagnetic compatibility information
- Cybersecurity information (for networked devices)
- Performance characteristics and limitations
- For implantable devices: information to be given to the patient
- Contact details for the manufacturer
- Date of issuance or last revision of IFU
- Legal manufacturer's notice for warnings or precautions
IVDR-specific IFU requirements
The IVDR IFU must additionally include:
- Measurement principle and analytical method
- Detailed instructions for each step of the procedure
- Performance data (analytical sensitivity, specificity, accuracy, precision, etc.)
- Known interfering substances and their effects
- Limitations of the method
- Expected values for relevant population(s)
- Reference ranges (normal values)
- Information on interpreting results
- For self-tests: simplified instructions for lay users; what to do with the result
When IFU may be omitted
For certain Class I and IIa devices, an IFU may be omitted if the device is intended for use by professional users and can be used safely without one. The label alone must then contain sufficient information. This is an exception — the default is that an IFU is required.
Electronic IFU (eIFU)
Under Commission Regulation (EU) No 207/2012 (and its successors), manufacturers of certain medical devices may provide the IFU in electronic format only (eIFU) rather than as a printed document. Requirements:
- Must not apply to devices intended for use by lay persons (home use, self-test)
- A printed copy must be available on request at no additional charge
- The label must contain the website address where the eIFU can be found
- The eIFU must be accessible, downloadable, and printable
- The eIFU must be updated when the device's IFU changes
Under IVDR, eIFU rules are specified in the regulation itself and Commission implementing measures.
Symbols in labelling
Manufacturers may use symbols instead of text where appropriate. Symbols must:
- Be standardised — ideally from EN ISO 15223-1 (Symbols to be used with information to be supplied by the manufacturer)
- Be accompanied by explanatory text if not universally understood in the intended markets
- Not be used if they could cause confusion with non-device products
Key symbols commonly used:
| Symbol | Meaning |
|---|---|
| REF | Catalogue/reference number |
| LOT | Lot or batch number |
| SN | Serial number |
| ∑ | Total number of units in packaging |
| ▶ | Consult instructions for use |
| i | Consult instructions for use (electronic) |
| 🌡 | Temperature limit (with range) |
| ✕ (single-use) | Do not reuse |
| STERILE | Sterile (method-specific variants exist) |
| ⏱ (expiry) | Use-by date |
| ⚠ | Caution / attention |
| CE mark | CE marking declaration |
Language requirements
Labels and IFU must be in the official language(s) of the member state(s) where the device is placed on the market. Multi-language documents are permitted. The language requirement:
- Applies separately in each member state
- May require translation of the full IFU for each market
- Symbols may reduce translation burden where standardised and unambiguous
Related pages
- GSPR overview — Annex I
- Chapter I — General requirements
- Chapter II — Design & construction
- GSPR checklist
- Labelling requirements
- UDI — labelling requirements
Official references
| Reference | Description |
|---|---|
| MDR Annex I, Section 23 | Labelling and IFU requirements |
| IVDR Annex I, Section 20 | IVDR equivalent |
| EN ISO 15223-1 | Symbols for medical device labelling |
| Commission Regulation (EU) No 207/2012 | eIFU rules |
| MDR Art. 32 | Implant card requirements |
| MDCG 2019-16 | Guidance on IFU content |