Class I self-declaration pathway

Regulatory basis

Class I self-declaration is governed by Schedule 3, Annex VII equivalent of Part I of the UK MDR 2002. Class I devices with sterile, measuring, or reusable surgical instrument aspects require partial UKAB involvement under the relevant annexes of Schedule 3.

Disclaimer

This site provides general information only and does not constitute legal or regulatory advice. Always verify your device's classification before relying on the self-declaration route.

Who can use the self-declaration pathway?

The self-declaration pathway is available for standard Class I medical devices — those that are:

Not placed on the market in a sterile condition
Do not have a measuring function
Are not reusable surgical instruments

If your Class I device falls into any of those three sub-categories, partial UKAB involvement is required (see below).

The self-declaration process

Step 1: Prepare the technical file

The manufacturer must compile a technical file demonstrating conformity with all applicable Essential Requirements (Schedule 1, UK MDR 2002). The technical file must include:

General description of the device and its intended purpose
Classification rationale (confirming Class I status under Schedule 2)
Essential Requirements checklist with evidence of conformity for each applicable ER
Design specifications, drawings, and manufacturing information
Risk management documentation (ISO 14971 risk file)
Clinical evaluation report or literature-based clinical evidence
Labelling and instructions for use (in English for the GB market)
Labelling samples or artwork
Quality management system description (ISO 13485 or equivalent)

The technical file does not need to be submitted to MHRA proactively — but it must be available for inspection on request, and must be retained for a minimum of 5 years from the date the last device was manufactured (or 15 years for implantable devices, noting most Class I devices are not implantable).

Step 2: Issue the UK Declaration of Conformity

The manufacturer issues a UK Declaration of Conformity (UK DoC) — a formal written declaration that:

Identifies the manufacturer and (if applicable) the UKRP
Describes the device (name, model, intended purpose, device identifier)
States that the device meets the Essential Requirements of the UK MDR 2002
References the Schedule 3 annex used (Annex VII equivalent for Class I self-declaration)
Is signed and dated by a responsible person at the manufacturer

The UK DoC must be kept on file and is available to MHRA and economic operators on request.

Step 3: Affix the UKCA mark

The manufacturer affixes the UKCA mark to the device (or its packaging/IFU where the device itself is too small or impractical to mark). The UKCA mark must appear clearly and legibly. For Class I self-declaration, the UKCA mark appears alone — no UKAB identification number is added.

Step 4: Register with MHRA

Before placing the device on the GB market, the manufacturer (or their UKRP for non-UK manufacturers) must register via the MHRA Submissions portal.

Registration includes:

Manufacturer/UKRP legal entity details
Device description and classification
Declaration of Conformity reference

Step 5: Place on the GB market

Once steps 1–4 are complete, the device may be placed on the GB market. Post-market obligations (PMS, vigilance reporting) begin at this point.

Class I sub-categories: where UKAB involvement is required

Class I (sterile) — devices placed on the market in a sterile condition

The manufacturer self-declares all Essential Requirements except those relating to sterility. For sterility aspects, a UKAB must:

Audit the sterilisation process validation and QMS
Issue a certificate covering the sterilisation process

The UKCA mark on sterile Class I devices is accompanied by the UKAB's identification number.

Documentation required beyond standard Class I technical file:

Sterilisation validation records (ISO 11135, 11137, 11138, or equivalent depending on sterilisation method)
Sterile barrier system validation (ISO 11607)
Environmental monitoring records for cleanroom manufacture
Bioburden data

Class I (measuring function) — devices with a measuring function

A measuring function means the device has a scale or numeric output where the accuracy of the measurement directly affects clinical decisions (e.g., a graduated syringe, a non-electronic thermometer).

The manufacturer self-declares all ERs except those relating to the measuring function. A UKAB must assess the metrology aspects — verifying that the device meets accuracy and precision requirements relevant to its measuring function.

The UKCA mark on measuring Class I devices is accompanied by the UKAB's identification number.

Class I (reusable surgical instruments — Class Im)

Reusable surgical instruments — instruments intended by the manufacturer to be reprocessed and used multiple times — require UKAB assessment of the aspects relating to reprocessing and reuse information. The UKAB reviews whether:

The manufacturer provides adequate instructions for cleaning, disinfection, sterilisation, and inspection between uses
The device is designed to withstand the specified number of reprocessing cycles

The UKCA mark on Class Im devices is accompanied by the UKAB's identification number.

CE marking and transitional acceptance

Class I devices from non-UK manufacturers currently relying on CE marking (under EU MDD or EU MDR) can continue to place those devices on the GB market under the transitional arrangements until 30 June 2030, without obtaining UKCA marking.

However, MHRA registration remains mandatory regardless of whether the device bears CE or UKCA marking.

Common pitfalls for Class I self-declaration

Pitfall	How to avoid
Claiming Class I for a device that should be Class IIa	Apply Schedule 2 rules rigorously; document rationale
Technical file too thin	Class I does not mean minimal evidence — all ERs must be addressed
Forgetting MHRA registration	Registration is mandatory even for self-declared Class I devices
No clinical evaluation	Even Class I devices require clinical evidence; literature review may suffice
Missing UKAB for sterile/measuring/Im sub-categories	Check whether your Class I device falls into a sub-category
Inadequate IFU	IFU must comply with Schedule 1 ER 18 regardless of class

Official references

Reference	Description
UK MDR 2002, Schedule 3, Annex VII equivalent	Class I declaration of conformity procedure
UK MDR 2002, Schedule 3	Conformity assessment procedures for all classes
MHRA: Conformity assessment for medical devices	MHRA guidance on conformity assessment routes
ISO 13485:2016	QMS standard
ISO 11607:2019	Packaging for terminally sterilised medical devices

Who can use the self-declaration pathway?​

The self-declaration process​

Step 1: Prepare the technical file​

Step 2: Issue the UK Declaration of Conformity​

Step 3: Affix the UKCA mark​

Step 4: Register with MHRA​

Step 5: Place on the GB market​

Class I sub-categories: where UKAB involvement is required​

Class I (sterile) — devices placed on the market in a sterile condition​

Class I (measuring function) — devices with a measuring function​

Class I (reusable surgical instruments — Class Im)​

CE marking and transitional acceptance​

Common pitfalls for Class I self-declaration​

Related pages​

Official references​