Single-use devices & reprocessing rules
MDR Art. 2(8) (single-use definition); MDR Art. 17 (reprocessing of single-use devices); MDR Annex I §23.4(h) (IFU requirements for single-use designation). Reprocessing of single-use devices is regulated — not prohibited — but the reprocessor takes on full manufacturer obligations.
This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and a qualified regulatory professional.
Single-use devices — definition and labelling
A single-use device is intended to be used on one individual during a single procedure. It is not intended to be reprocessed and used on another individual.
Single-use devices must be clearly labelled with the single-use symbol (ISO 7000-1051, a circle with a 2 and a cross through it) on the device and its packaging. The IFU must explicitly state the device is for single use and include any maximum number of uses if relevant.
Why single-use designation matters
Manufacturers designate devices as single-use for various reasons:
- Clinical safety: the device cannot be reliably cleaned or sterilised
- Performance: reuse degrades performance below acceptable limits
- Sterility: sterility cannot be re-established after use
- Structural integrity: the device may deform or fail on re-use
However, single-use designation also carries regulatory consequences — the manufacturer takes full responsibility for that single use and is not responsible for harm arising from unauthorised reprocessing.
Reprocessing of single-use devices — MDR Art. 17
MDR does not prohibit the reprocessing of single-use devices. Instead, it creates a regulatory framework under Art. 17:
Member state opt-in
Reprocessing of single-use devices is permitted only in member states that have adopted national provisions allowing it. Some member states have banned it entirely; others permit it under defined conditions.
Reprocessor becomes the manufacturer
The critical principle: any entity that reprocesses a single-use device takes on the obligations of a manufacturer for the reprocessed device. This means:
- The reprocessor becomes legally responsible for the reprocessed device
- The reprocessor must ensure the reprocessed device meets all applicable GSPR
- The reprocessor must conduct a conformity assessment appropriate to the device's class
- The reprocessor must register in EUDAMED
- The reprocessor must comply with all post-market obligations
Requirements the reprocessor must meet
- Demonstrate equivalent safety and performance: the reprocessed device must be at least as safe and perform at least as well as the original
- Reprocessing validation: the reprocessing process (cleaning, disinfection/sterilisation) must be validated
- Technical documentation: documentation equivalent to that required for the original device
- Labelling: the reprocessed device must be labelled with the reprocessor's name and address, and clearly identified as reprocessed
Class Ir — reusable surgical instruments
For reusable devices that are not single-use, the manufacturer must:
- Provide validated reprocessing instructions in the IFU (cleaning, disinfection, sterilisation steps)
- Specify the maximum number of reprocessing cycles (where applicable)
- Validate that the device remains within specification after the maximum stated number of reprocessing cycles
For Class Ir devices (reusable surgical instruments), the notified body assesses the reprocessing aspects of the device as part of conformity assessment. The manufacturer's reprocessing validation is a key element of the technical documentation.
Related pages
Official references
| Reference | Description |
|---|---|
| MDR Art. 2(8) | Single-use device definition |
| MDR Art. 17 | Reprocessing of single-use devices |
| MDR Annex VIII Rule | Class Ir classification |
| MDR Annex I §23.4(h) | IFU requirement for single-use labelling |
| EN ISO 17664 series | Reprocessing of medical devices — information from the manufacturer |
| MDCG 2022-4 | Guidance on reprocessing of single-use devices |