Medical devices class I s
Class Is (I sterile) is a subclass of Class I under MDR (EU) 2017/745. Class I products are normally conformity-assessed without a Notified Body. For Class Is, however, a Notified Body must be involved for the aspect of sterilising the product.
This means:
- The product itself (design, materials, labelling) remains Class I
- The sterilisation process and its validation are assessed by the Notified Body
- Typical Class Is products: sterile surgical gloves (EN 455), sterile wound dressings, sterile single-use instruments
The Notified Body assesses for Is specifically:
- Validation of the sterilisation process
- Maintenance of sterility (packaging, storage)
- SAL demonstration (Sterility Assurance Level 10^-6)
Distinctions:
- Class Im: Class I with measuring function - Notified Body for measuring function
- Class Ir: Class I reusable surgical - Notified Body for reprocessing
- Class Is: Notified Body for sterilisation
Frequently asked questions
Why does Class Is require a Notified Body even though the product is Class I?
Sterilisation is a critical process that must be validated. The manufacturer cannot self-confirm validation alone. The MDR therefore requires Notified Body involvement for Is specifically for the sterilisation aspect.
Which surgical gloves are Class Is?
Sterile surgical gloves per EN 455 are typical Class Is products. The glove design and materials remain Class I; the sterilisation process (EO, gamma, or steam) requires a Notified Body.
How do Is, Im, and Ir differ?
Is: supplied sterile, Notified Body for sterilisation. Im: has a measuring function (e.g. thermometer), Notified Body for that function. Ir: reusable surgical instrument, Notified Body for reprocessing aspect. All three are subclasses of Class I.