UK Declaration of Conformity for Medical Devices

1. Key takeaways

Devices placed on the market in Great Britain must hold a UK Declaration of Conformity citing UK MDR 2002, and an EU DoC cannot simply be substituted for it. The duty to draw up the declaration rests with the manufacturer, while the UKRP’s legal obligation is to ensure that the declaration has been drawn up and to keep a copy of it. Under the CE-marking transition routes (regs 19B, 19C, 30A, 44ZA, 44ZB), the declaration carries additional anchoring requirements: when it was issued and which law it cites are both pinned to specific dates and specific versions of the underlying directives. These are not drafting niceties. The transition provisions ask whether the declaration existed at a fixed point in time and whether its citation text was frozen at a particular legal moment, and a declaration that fails either test cannot support transitional status, however sound the rest of the file may be. Manufacturers relying on the extended CE recognition windows should therefore audit their declaration inventory against the dates and citation wording described below before the audit is forced on them by an MHRA data check or a UKRP due-diligence exercise. The sections below set out those anchoring requirements in detail, followed by the template elements GRZAN recommends fixing for every UK declaration issued.

2. Legal basis

• UK MDR 2002 (SI 2002/618, as amended): reg 44ZD and other Part 4A definition provisions; reg 19B(3)(f), reg 30A(3)(f) and reg 44ZA(3)(f), which require that the declaration was drawn up before 26 May 2021 (for IVDs, before 26 May 2022) in accordance with the corresponding directives.
• SI 2023/627, regs 6(3)(c), 8(3)(b) and 9(3)(c): these replace the wording “draws up” with “has drawn up before 26 May 2021 / 26 May 2022”, confirming that a declaration made after the cut-off cannot satisfy the transition conditions.
• Official guidance: GOV.UK, Regulating medical devices in the UK, which lists among the UKRP’s duties ensuring that the Declaration of Conformity has been drawn up and holding a copy available for inspection.

3. Expert insights

Insight one: the declaration’s time anchor is a hard condition of transitional status. Reg 19B(3)(f) and reg 30A(3)(f) require that the declaration was drawn up before 26 May 2021; reg 44ZA(3)(f) applies the equivalent condition to IVDs with a cut-off of 26 May 2022. The wording adopted by SI 2023/627, “has drawn up before”, makes the sequence unmistakable: the document must already have existed on the relevant date. A declaration backfilled afterwards, however accurate its content, cannot cure a missing time anchor. Companies consolidating legacy paperwork should therefore treat the date of issue as evidence in its own right, and where the historical record is unclear, the gap should be resolved through the applicable conformity assessment route rather than through retrospective documentation.

Insight two: the law cited in the declaration must be frozen at a specific version. SI 2023/627, regs 6(2)(a) and 8(2)(a), changed the required citation to Directive 93/42 as it had effect on 25 May 2021 and Directive 90/385 as it had effect on 25 May 2021, and deleted the phrase “as amended from time to time”. This matters because the cited directives continue to be amended at the EU level for EU purposes, while the UK transition conditions refer to a historical snapshot. A declaration that cites the directives in open-ended, always-current terms does not match the statutory wording, and an incorrect citation can cause the transitional qualification to fail even where the underlying product file is entirely sound. Citation wording deserves the same document-control discipline as the technical content itself.

Insight three: the UK DoC and the EU DoC are two separate documents. Even where a product already holds CE certification and an EU declaration exists, entering the UK market calls for a separately issued UK DoC. The UK document is the direct evidence examined during MHRA data verification of registration records and during the due diligence a UKRP is expected to perform before accepting an appointment. Keeping only the EU declaration on file leaves the UK-side evidence chain incomplete and forces improvised answers at exactly the moment a regulator or authorised representative asks for documents. GRZAN recommends issuing the UK DoC as a distinct, versioned record rather than annotating the EU document. GRZAN also suggests keeping the two documents under separate reference numbers even where their content overlaps, since regulators and authorised representatives request them by name.

4. Practical recommendations

GRZAN recommends fixing the following elements in the UK DoC template: the manufacturer’s name and address; the UKRP’s name and address where applicable; the device identification, including the GMDN code and the Basic UDI-DI where applicable; the UK regulations and the specific provisions cited; the device classification; the conformity assessment procedure followed and, where applicable, the number of the UK approved body involved; and the place and date of issue together with the authorised signatory. Because declarations are issued device by device, the template alone is not enough: each issued declaration should be checked individually to confirm that its citation wording and date of issue meet the anchoring requirements of the transition provisions. GRZAN suggests maintaining a declaration register that records, for every device family, the issue date, the citation version and the UKRP copy-holding status, so that the anchor conditions can be demonstrated without reconstructing history from scattered files.

5. Verification checklist

• □ A standalone UK DoC has been issued, not an EU DoC used in substitution
• □ The citation wording is frozen to the version of 25 May 2021 (for IVDs: 25 May 2022)
• □ The declaration was issued before 26 May 2021 (for IVDs: 26 May 2022)
• □ The UKRP holds a copy of the DoC
• □ The GMDN code and applicable device identification information are included

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 Declarations of Conformity and related conformity documentation, contact GRZAN at info@grzanglobal.com.