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UK Declaration of Conformity

Regulatory basis

The UK Declaration of Conformity requirement is established by the UK MDR 2002 (SI 2002/618 as amended by SI 2019/791). The DoC replaces the EU Declaration of Conformity for the GB market. It must be drawn up before the UKCA mark is affixed and before the device is placed on the GB market.

What is a UK Declaration of Conformity?​

The UK Declaration of Conformity (UK DoC) is a formal written statement in which the manufacturer declares, under their sole responsibility, that their medical device complies with all applicable requirements of the UK Medical Devices Regulations 2002.

It is not a certificate issued by MHRA or a UKAB — it is the manufacturer's own legal declaration. For higher-risk devices, this declaration is backed by the independent assessment of a UK Approved Body.

The UK DoC is:

  • Required for all medical devices placed on the GB market
  • Issued by the manufacturer (or UKRP on their behalf where specified)
  • Referenced on device labels and packaging (or available on request)
  • Kept on file for a minimum of 5 years (15 years for implantable devices) after the last device was manufactured

Required contents of the UK DoC​

While the UK MDR 2002 does not specify a mandatory template, the UK DoC must contain sufficient information to:

  1. Identify the device: Name, model number(s), intended purpose, device description, and any variants covered
  2. Identify the manufacturer: Full legal name and registered address
  3. Identify the UKRP (where applicable): Full legal name and registered address in Great Britain
  4. State the conformity assessment procedure used: Reference to the specific Schedule 3 annex(es) applied (e.g., "Conformity assessed in accordance with Annex II equivalent procedure under Schedule 3 of the UK MDR 2002")
  5. Identify the UKAB (where applicable): Name, address, and UKAB identification number; certificate number and date of issue
  6. Declare conformity with applicable Essential Requirements: Reference to Schedule 1 or Schedule 1A of UK MDR 2002
  7. List applicable UK-designated standards and/or Common Specifications applied
  8. Be signed and dated by a person authorised to act on behalf of the manufacturer, with their name and title
  9. Bear the date of issue

Example UK DoC structure​

UK DECLARATION OF CONFORMITY

Manufacturer: [Full legal name and address]
UK Responsible Person (if applicable): [Full legal name and GB address]

Device name: [Name]
Device description: [Brief description and intended purpose]
Model / catalogue number(s): [List all models covered]

This device conforms to the requirements of the UK Medical
Devices Regulations 2002 (SI 2002/618 as amended).

Conformity assessment procedure: Annex II equivalent under
Schedule 3 of the UK MDR 2002 (Full Quality System procedure)

UK Approved Body: [Name, address, UKAB ID number]
Certificate number: [Number]   Date of issue: [Date]

UK-designated standards applied:
- ISO 13485:2016
- ISO 14971:2019
- IEC 60601-1:2005+A1:2012 (UK-designated)
- [Other applicable standards]

Signed: ____________________
Name: [Name]
Title: [Title]
Date: [Date]

UK DoC vs EU Declaration of Conformity​

Manufacturers with both GB and EU market access need both a UK Declaration of Conformity (for GB) and an EU Declaration of Conformity (for EU and NI). These are separate documents referencing separate regulatory frameworks.

AspectUK Declaration of ConformityEU Declaration of Conformity
Framework referencedUK MDR 2002 (SI 2002/618)EU MDR 2017/745 or EU IVDR 2017/746
Mark appliedUKCACE
UKAB/NB referencedUK Approved BodyEU Notified Body
Applicable toGB marketEU market + NI market
Standards referencedUK-designated standardsEU harmonised standards
Regulatory basis statementRefers to UK statutory instrumentRefers to EU Regulation number

Under the CE marking transitional acceptance (until 30 June 2030), a manufacturer can use their EU DoC for GB market access — they do not need a separate UK DoC during this period, provided they also complete MHRA registration.

Maintaining the UK DoC​

The UK DoC must be kept current. It must be updated when:

  • The device undergoes a design change that affects conformity with the Essential Requirements
  • The manufacturer changes the conformity assessment procedure
  • A UKAB certificate is renewed, updated, or reissued with a new certificate number
  • The manufacturer's details change (name, address)
  • The UKRP changes

When significant changes occur, the manufacturer must reassess conformity with the Essential Requirements and issue a new or revised UK DoC.

Who can sign the UK DoC?​

The UK DoC must be signed by a person who has the authority to bind the manufacturer — typically:

  • A director or officer of the manufacturing company
  • A person explicitly authorised in writing by the manufacturer to sign DoCs
  • The designated quality/regulatory responsible person

For non-UK manufacturers: the UKRP does not typically sign the UK DoC (the manufacturer does), but UKRP details must be included.

DoC and the UKCA mark​

The UKCA mark may only be affixed to a device after the UK DoC has been issued. The UKCA mark signals to the market that:

  1. A UK DoC exists
  2. The conformity assessment procedure has been completed
  3. The device meets the applicable Essential Requirements

The UKCA mark and the UK DoC are inseparable — one cannot exist without the other.

Official references​

ReferenceDescription
UK MDR 2002, Schedule 3Conformity assessment procedures and DoC requirements
SI 2019/791Post-Brexit amendments establishing the UK DoC requirement
MHRA: UKCA marking guidanceGuidance on DoC and UKCA marking
EU MDR 2017/745, Annex IVEU DoC requirements (for NI/EU — comparative reference)