When classifying medical devices, one should apply the classification criteria that take into account the duration of contact between the medical device and a person and the degree of invasiveness of the device.
Duration of contact:
- Momentary (up to 60 minutes)
- Short-term (up to 30 days)
- Long term (more than 30 days)
Degree of invasiveness:
- Applied through skin or body orifices
- Surgical Invasive
- implantable
The correlation of the above factors gives us the basis for further classification, a simple diagram of which is given in the table below. The higher the class, the greater the risk of a given product.
| CATEGORY | CHARACTERISTICS | ASSESSMENT OF CONFORMITY | DOCUMENTATION / EXAMPLES |
|---|---|---|---|
| CLASS I | – non-invasive – low risk | Assessment by the manufacturer | Declaration of conformity / cane |
| CLASS IIa | – short term invasive – without significant effects on the body and its fluids | Notified body | Certificate of compliance / urological catheter |
| CLASS IIb | – long-term invasive – significant effects on the body or its fluids | Notified body | Certificate of compliance (evaluation procedure requires clinical data) / hip prosthesis |
| CLASS III | – can be life-threatening – completely absorbed – they contain the drug – animal origin | Notified body | Certificate of compliance (evaluation procedure requires clinical data) / biological heart valve |
Only in the first case the conformity assessment is carried out by the manufacturer himself. In the case of other classes, the risk of use is so high that the presence of a notified body in the conformity assessment procedure is necessary.
After the initial classification of medical devices and determination of the degree of invasiveness, the classification rules should be applied. This problem is regulated by the Regulation of the Minister of Health of April 30, 2004 on the classification of medical devices for various purposes.
The issue of classification rules is very extensive, but there are four main rules to which a given product should be assigned, and within which there are additional sub-rules:
- Rules applicable to non-invasive medical devices,
- Rules applied to invasive medical devices,
- Additional rules applicable to active medical devices,
- Special rules
Assigning a medical device to a given rule is the starting point for further classification according to classification paths, which differ depending on the different groups of medical devices.
It should be remembered that the issue of in vitro diagnostic medical devices and active implant medical devices is regulated by a separate directive (the In Vitro Diagnostic Directive and the Active Implant Medical Device Directive, respectively).
When the class of a medical device is finally determined, the procedure leads to obtaining a CE Declaration of Conformity in accordance with the directive on medical devices MDD 93/42 / EEC with attachments (annexes).
autor: MJ