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Labelling requirements

Regulatory basis

Labelling requirements are in Schedule 1, Essential Requirement 18 of the UK MDR 2002. For IVDs, the equivalent requirements are in Schedule 1A of Part III. All devices placed on the GB market must comply with these labelling requirements regardless of whether they bear a UKCA or CE mark.

Purpose of labelling requirements​

Medical device labelling must provide sufficient information for:

  • The intended user to use the device safely and effectively for its intended purpose
  • Traceability throughout the supply chain
  • Identification of the manufacturer and UKRP
  • Identification of the regulatory status of the device (UKCA/CE marking)

Mandatory label elements (Schedule 1, ER 18)​

The following information must appear on the label or, where this is not practicable due to the nature of the device, on the packaging or in the instructions for use:

1. Manufacturer identification​

  • The name or trade name and the address of the manufacturer
  • For devices manufactured outside the UK: in addition to the manufacturer's details, the name and address of the UK Responsible Person (UKRP) must be stated

2. Device identification​

  • The device name or trade name
  • Any alphanumeric code that allows identification of the device type, model, and version
  • Catalogue number (or equivalent reference allowing identification)
  • Batch/lot number (preceded by "Lot") or serial number (preceded by "SN")

3. UKCA mark / CE mark​

  • The UKCA mark (for devices compliant with UK MDR 2002 under UKCA route) or the CE mark (for devices relying on CE marking under transitional acceptance)
  • For devices requiring UKAB involvement: the UKAB identification number alongside the UKCA/CE mark

4. Dates​

  • The date by which the device should be used expressed as at least the year and month ("Use by" or expiry date — for sterile devices and IVDs especially)
  • Date of manufacture (where applicable)

5. Sterility status​

  • For sterile devices: the word "STERILE" or the sterile symbol (EN ISO 7000-1051 or equivalent)
  • Sterilisation method (if relevant for safe use, e.g., EO sterilised)

6. Single-use designation​

  • If the device is for single use: the single-use symbol (1 in a circle with a stroke) or "Do not re-use" statement

7. Implant indication​

  • Indication that the device is an implantable device (where applicable)

8. Warnings and precautions​

  • Any special storage or handling requirements
  • Any special operating instructions
  • Warnings or precautions that must be brought to the attention of the user

9. For IVDs additionally:​

  • The "IVD" symbol or the words "In Vitro Diagnostic"
  • For List A and List B devices: the CE mark (or UKCA mark) with the UKAB number
  • Performance characteristics summary
  • Specimen type(s) intended

Language requirements​

All mandatory label information must be in English for the GB market. Additional languages may be included but English is required. Instructions for Use must be in English.

UKRP on the label​

For devices placed on the GB market by a non-UK manufacturer, the label (or packaging or IFU where the label is too small) must include the UKRP's name and address. The UKRP must be identified as such (e.g., "UK Responsible Person:" followed by name and address).

This requirement applies whether the device bears a UKCA or CE mark.

Instructions for Use (IFU)​

Every device must be accompanied by instructions for use (IFU) unless the device is Class I or Class IIa and can be used safely without such instructions. IFU must include all information needed for safe use that cannot be included on the label itself.

IFU may be provided:

  • As a printed document in the package
  • As an electronic IFU (eIFU) — subject to MHRA guidance on eIFU eligibility for specific device types

Official references​

ReferenceDescription
UK MDR 2002, Schedule 1, ER 18Full labelling requirements for general devices
UK MDR 2002, Part III, Schedule 1AIVD labelling requirements
MHRA: Labelling guidance for medical devicesMHRA's labelling guidance
ISO 15223-1Symbols to be used with information to be supplied by the manufacturer