UK Labelling and Instructions for Use Requirements

1. Key takeaways

UK labelling obligations turn on a single dividing line: whether UKCA is affixed. Where UKCA is affixed, the UKRP’s name and address must appear on the product label, the outer packaging or the instructions for use. Where only CE marking is held, the UKRP’s information does not need to appear on the label. Where both CE and UKCA are affixed, the UKRP information must appear. In addition, where a UK conformity assessment body is involved, its number must appear adjacent to the UKCA mark. These four outcomes follow from the marking decision alone, which is why the decision deserves to be treated as a commercial and regulatory choice made deliberately, not as a compliance detail delegated to packaging. Every downstream consequence, label artwork, packaging inventory, IFU versions and DORS data consistency, flows from it. Companies should also remember that the rules operate per device family under the three separate parts of UK MDR 2002, so the analysis must be repeated for general devices, active implantable devices and IVDs rather than assumed company-wide. The sections below trace those consequences through the relevant provisions, explain the language requirement that applies regardless of the marking route, and describe the error-marking provisions that make labelling mistakes a regulatory matter rather than a reprint. Because the trigger is the mark, the marking decision should be recorded per device family and revisited whenever the route into the UK changes.

2. Legal basis

• UK MDR 2002 (SI 2002/618, as amended): reg 10 and reg 10A (marking for general devices and the UK(NI) indication), reg 24 and reg 24A (active implantable devices), reg 36 and reg 36A (IVDs), regs 13/27/40 (the affixing procedures), and Part V reg 50 (incorrect affixing of the body’s number) and reg 51 (incorrect affixing of a UK mark).
• Official guidance: GOV.UK, Regulating medical devices in the UK, including the paragraphs on UKRP labelling requirements.

3. Expert insights

Insight one: the trigger for labelling obligations is the mark, not the pathway. This is the most counter-intuitive feature of the UK labelling rules. A manufacturer using the CE transition route may have appointed a UKRP and completed MHRA registration, yet does not need to print the UKRP on the label, because only CE marking is affixed. Conversely, the moment the decision is made to affix UKCA, a label change becomes necessary at once. GRZAN finds that companies often discover this in reverse, by ordering label artwork before formally deciding the marking strategy. The efficient sequence is the opposite: decide the marking position first, per device family and per market, and let the label requirements follow mechanically from that decision. GRZAN recommends making the UKRP-on-label question a standing item in artwork reviews, so the answer follows the mark automatically rather than depending on individual memory.

Insight two: the language requirement is a hard practical constraint. The official guidance, in the provisions relating to system and procedure packs such as reg 19B(7)(d), explicitly requires English. For the UK market, instructions for use and labelling should be provided in English. This is not satisfied by multilingual artwork that buries the English text, and it applies regardless of which marking route the product uses. Companies shipping into both the EU and GB should plan separate IFU versions rather than attempting one pan-European document, because the language obligations of the two markets no longer align. Translations should be produced and reviewed as controlled documents, with version numbers aligned to the corresponding artwork releases.

Insight three: incorrect marking has dedicated provisions. Part V contains reg 50, on the incorrect affixing of a conformity assessment body’s number, and reg 51, on the incorrect affixing of a UK mark. Together they form the basis for dealing with identification breaches. Labelling errors are therefore not minor matters to be settled by correcting the next production batch; they engage the regulations directly. GRZAN recommends treating any marking discrepancy as a reportable internal quality event with a documented root cause, so that the corrective record exists if the issue is later examined. A documented correction process also protects commercial relationships, since distributors often learn of labelling problems before the manufacturer does.

4. Practical recommendations

GRZAN recommends running a marking decision and label impact assessment before any UK label change begins. The assessment follows four steps in order: determine whether UKCA will be affixed; derive from that whether UKRP information must appear on the label; derive whether a body number must appear adjacent to UKCA; and only then define the scope of the artwork change and the disposition of existing stock. In parallel, the organisation address entered at DORS registration must match exactly what is shown on the label; a mismatch triggers an inconsistency during MHRA data verification of the registration record. GRZAN suggests adding a label-versus-DORS comparison to the pre-release checklist for every new SKU, since the two records are maintained by different teams and drift apart quietly over time. For dual-marked products, GRZAN suggests archiving the approved label artwork alongside the DORS record, so the consistency check has a permanent reference.

5. Verification checklist

• □ Whether UKCA is affixed, alone or as a dual mark, has been confirmed
• □ UKRP information appears on the label where required
• □ The UK conformity assessment body number is marked adjacent to UKCA
• □ Labels and instructions for use are provided in English
• □ The DORS registration address matches the label address

Regulatory information verified as of 29 October 2026.

GRZAN supports manufacturers entering the UK market with the preparation and maintenance of registration documentation and conformity documentation. Our services for the UK market include:

• UK Responsible Person (UKRP) appointment and authorisation letter support
• Full MHRA registration (DORS) filing and account lifecycle management
• Device classification, GMDN code selection and annual registration fee calculation
• Great Britain and Northern Ireland dual-pathway design and UK(NI) solutions
• Post-market surveillance (PMS) system setup, PMSR/PSUR preparation and vigilance reporting
• Serious incident and field safety corrective action (FSCA) emergency response
• UK regulatory change monitoring and compliance gap assessment

For tailored support with UK labelling, instructions for use and conformity documentation, contact GRZAN at info@grzanglobal.com.