Glossary

Single-use devices

Back to glossary index

What it is

Single-use device (SUD) is a medical device intended to be used on one patient during a single procedure and then discarded. The definition is set in EU law (MDR 2017/745 Art. 2(10)); in the U.S., labeling and the manufacturer’s intent determine “single-use” status, and reprocessors are regulated as manufacturers. SUDs aim to reduce cross-contamination and simplify processing, but they must still meet all safety, performance, and quality requirements.

One patient • One useRisk & labeling drivenNo reprocessing unless allowed

Regulatory framework

  • EU (MDR): Definition (Art. 2(10)); reprocessing of SUDs (Art. 17) with Member-State rules and Annex I GSPRs; labeling/IFU and symbols (Annex I Ch. III; ISO 15223-1); technical documentation (Annex II–III); UDI/EUDAMED (Arts. 27–29).
  • US (FDA): Device requirements apply to SUDs based on intended use (FD&C Act §201(h)); labeling (21 CFR 801 incl. UDI 21 CFR 801 Subpart B/21 CFR 830); quality system (21 CFR 820 QMSR); registration/listing (21 CFR 807). Reprocessed SUDs are treated as new manufactured devices and typically require a 510(k) or PMA, plus full CGMP/QMSR compliance.
  • Standards: ISO 13485 (QMS), ISO 14971 (risk), ISO 11135/11137/17665 & ISO 11607 (sterilization/packaging), ISO 15223-1 (symbols), IEC 62366-1 (usability) as applicable.

Key elements

  • Intended purpose & labeling: Clear “single-use” indication, contraindications, and disposal instructions; symbols per ISO 15223-1.
  • Sterility & packaging: Validated sterilization and packaging integrity/shelf life; transport and storage limits supported by evidence.
  • Traceability: UDI on labels/pack; lot/serial controls feeding complaints, vigilance, and recalls.
  • Performance & risk: Design and verification show safety and performance for one use; misuse (re-use) addressed in risk management (ISO 14971).
  • Reprocessing controls: EU: only under Art. 17 with strict conditions; US: third-party or hospital reprocessors assume full manufacturer obligations.

Process — how it works

  • Define & classify: State the single-use intent in intended purpose and labeling; apply EU class rules (Annex VIII) or US class/predicate logic.
  • Design & validate: Engineer for one procedure; validate sterilization, packaging, biocompatibility, and usability; set shelf life and storage limits.
  • Build the file: Compile Annex II–III technical documentation (EU) or U.S. submission/QMS records with UDI data and GSPRs/standards mapping.
  • Label & register: Apply UDI (EU/US); register devices (EUDAMED/GUDID as applicable); release with controlled IFU.
  • Monitor & act: Run PMS/vigilance; trend complaints and evaluate any field reuse risks; execute CAPA/recalls when needed.

Common pitfalls

  • Ambiguous labeling that fails to communicate single-use or disposal instructions.
  • Packaging/sterility validations that do not reflect real-world shipping, storage, or opening scenarios.
  • UDI or lot traceability gaps that hinder complaint trending and recalls.
  • Ignoring foreseeable re-use in the risk file, which weakens warnings and training content.
  • EU reprocessing of SUDs without meeting MDR Art. 17 conditions; U.S. reprocessing without appropriate 510(k)/PMA and QMSR compliance.

Quick checks

  • Does the IFU and symbol set clearly state single-use and disposal?
  • Are sterilization, packaging integrity, and shelf life fully validated and documented?
  • Is UDI/lot information accurate on all package levels and in the database?
  • Does the risk file address foreseeable re-use and user training needs?
  • If reprocessing is planned/allowed, do you meet MDR Art. 17 (EU) or full FDA manufacturer obligations (US)?

FAQ

Can single-use devices be reprocessed?

EU: Only under MDR Art. 17 and Member-State conditions with equivalent safety and performance and full documentation. US: Reprocessors are treated as manufacturers and typically need a 510(k) or PMA plus full QMSR compliance.

How should single-use be shown on labels?

Use clear wording and the ISO 15223-1 “Do not re-use” symbol; include disposal and infection-control instructions consistent with the risk file and IFU.

Do SUDs require the same evidence as other devices?

Yes. SUDs must meet GSPRs/CGMP, including biocompatibility, sterilization/packaging validation, performance testing, and PMS/vigilance expectations.

What is the difference between single-use and single-patient multiple-use?

Single-use: one procedure then discard. Single-patient multiple-use: the same patient may use the product multiple times; cleaning/maintenance instructions and evidence are required.

Are there special UDI rules for SUDs?

UDI is required on the label/pack (and on direct part marking only if other rules apply). Ensure database entries (EUDAMED/GUDID) match labeling and are kept current.