Systems & procedure packs
Systems and procedure packs are addressed in Regulation 12 of the UK MDR 2002. The person assembling a system or procedure pack has defined obligations under UK MDR 2002, which differ from those of a manufacturer.
What is a system or procedure pack?
A system is a combination of products packaged together and intended to be interconnected or combined to achieve a specific medical purpose.
A procedure pack is a combination of products packaged together to be used for a specific medical intervention or procedure.
Examples:
- A sterile surgical pack containing drapes, gowns, and instruments for a specific operation
- A wound care pack combining a dressing, saline, and applicators
- A catheterisation pack combining a catheter, drainage bag, and lubricant
- A vascular access pack combining a catheter, needle, and fixation dressing
Who assembles systems and procedure packs?
Systems and procedure packs are typically assembled by:
- Medical device distributors or wholesalers
- Hospital central sterile supply departments (CSSDs)
- Contract pack assemblers
The assembler may or may not be the manufacturer of any of the individual components.
The assembler's obligations
Under Regulation 12, the assembler of a system or procedure pack must ensure that:
- All individual components in the pack bear the UKCA mark (or CE mark under transitional acceptance) — i.e., they are individually compliant medical devices (or other compliant products)
- The combination and packaging does not compromise the safety and performance of the individual components
- The system or procedure pack bears the assembler's name, address, and trade name (if any)
- Where the pack is supplied sterile: the sterilisation is validated and the pack bears the required sterility labelling
The assembler must prepare a statement (equivalent to an Annex XII statement in EU MDD terms) that:
- Identifies the components in the pack and confirms they bear the UKCA/CE mark
- Confirms that the combination process was carried out in accordance with the manufacturers' instructions
- Confirms that the assembly did not compromise individual device compliance
When does assembling a pack make you a manufacturer?
If the assembler combines devices in a way not envisaged by any individual manufacturer — creating a new combination that constitutes a new device with its own claims and indications — the assembler may become the manufacturer of a new medical device.
This is a key distinction:
| Scenario | Regulatory position |
|---|---|
| Assembling individually compliant devices into a pack per their manufacturers' instructions | Assembler under Regulation 12 — simplified obligations |
| Creating a new combination with new claims, new intended purpose, or sterilising without a validated process | Manufacturer of a new medical device — full UK MDR 2002 obligations |
Related pages
Official references
| Reference | Description |
|---|---|
| UK MDR 2002, Regulation 12 | Systems and procedure packs |
| MHRA: Systems and procedure packs guidance | MHRA guidance |
| EU MDD 93/42/EEC, Article 12 | Source provision for UK Regulation 12 |