Single-use devices
Single-use device labelling requirements are in Schedule 1, Essential Requirement 18 (IFU and labelling) of the UK MDR 2002. Reprocessed single-use devices are addressed in MHRA guidance and are a distinct regulatory category in the UK reform programme.
What is a single-use device?
A single-use device is a device intended by its manufacturer to be used on one individual patient during a single procedure. Once used, the device must not be reprocessed and reused on another patient (or even on the same patient in a subsequent procedure, unless explicitly stated).
Single-use status is determined by the manufacturer's intent — communicated through labelling and IFU — not by the physical characteristics of the device alone.
Mandatory labelling for single-use devices
All devices designated as single-use must bear the single-use symbol (the international symbol of a "1" inside a circle with a line through it — ISO 7000-1051) or an explicit "Do not reuse" statement on the label. This is an Essential Requirement under Schedule 1, ER 18.
The IFU must also explicitly state that the device is for single use only and must not be reprocessed or reused.
Why reuse of single-use devices is prohibited
Single-use devices are typically designed and validated for a single use only. Reuse may:
- Compromise sterility (microbiological contamination)
- Compromise structural integrity (mechanical failure during reuse)
- Cause cross-contamination between patients
- Invalidate any performance claims (performance validated for single use only)
- Expose the reprocessing entity to regulatory and liability risk
Healthcare facilities that reprocess and reuse single-use devices against the manufacturer's instructions take on responsibility for any harm resulting from that reuse.
Reprocessed single-use devices (UK-unique)
In the UK, entities that reprocess single-use devices and supply them for use on patients may themselves be acting as manufacturers of a medical device — the reprocessed device — and may be subject to UK MDR 2002 obligations.
MHRA has published guidance acknowledging that reprocessing of single-use devices occurs in some NHS settings and has indicated that:
- Entities reprocessing single-use devices for supply to others are subject to UK MDR 2002 as manufacturers
- Reprocessing must be validated to demonstrate that the device performs safely after reprocessing
- The reprocessing entity must ensure the reprocessed device meets all applicable Essential Requirements
- Specific guidance on validated reprocessing standards applies (ISO 17664, relevant cleaning/sterilisation standards)
This is a UK-unique regulatory position in the RAPath context — a distinct regulatory acknowledgment of reprocessed SUD as a regulated device category.
The EU MDR 2017/745 (applying in NI) has specific provisions on reprocessed single-use devices (Article 17) that are more prescriptive than the current UK MDR 2002 position. MHRA's reform programme may introduce equivalent provisions for GB.
Related pages
Official references
| Reference | Description |
|---|---|
| UK MDR 2002, Schedule 1, ER 18 | Labelling and IFU requirements including single-use |
| MHRA: Reprocessing of single-use medical devices | MHRA guidance on reprocessing |
| ISO 17664:2017 | Processing of health-care products — reprocessing information |
| EU MDR 2017/745, Art. 17 | EU reprocessed SUD provisions (applies in NI — comparative reference) |