Medical devices class I r
Class Ir (I reusable) is a subclass of Class I under MDR (EU) 2017/745. It covers reusable surgical instruments where the reprocessing aspect (cleaning, disinfection, sterilisation) places special requirements.
Typical Class Ir products:
- Simple surgical forceps
- Scalpel handles (without blade)
- Surgical scissors without active components
- Simple retractor instruments
- Involved exclusively for the reprocessing aspects (validation of cleaning/sterilisation)
- Assesses whether the manufacturer's reprocessing instructions are valid and safe
- The instrument itself remains Class I
Key point: when reprocessing medical devices, it must be ensured that cleaning and sterilisation do not impair product properties. The Notified Body assesses the number of permissible cycles, compatibility with sterilisation methods, and end-of-life indicators.
Distinction: single-use products are explicitly not Class Ir. Reuse of single-use products constitutes a product conformity violation.
Frequently asked questions
Why does Class Ir require a Notified Body?
Incorrectly reprocessed surgical instruments can cause infection risks and lose their mechanical properties. The MDR requires that reprocessing instructions and cycle limits are validated by a Notified Body.
Can gloves be Class Ir?
No. Gloves are generally single-use articles and therefore not Class Ir. Medical single-use gloves carry the 'not reusable' symbol and must not be reprocessed.
What is the difference between Class Is and Class Ir?
Class Is: single-use articles supplied sterile - Notified Body for sterilisation. Class Ir: reusable surgical instruments - Notified Body for reprocessing. Both are subclasses of Class I.