The conformity assessment procedure authenticates that the product is in compliance with the corresponding European legislation. What this procedure looks like for your specific product depends on what category the medical device belongs to.
The following classes have been established in accordance with the Medical Devices Regulation:
- Class I, e.g. simple wound dressing.
- Class I with a measuring function, e.g. non-active oral thermometer.
- Class I sterile, e.g. sterile simple wound dressing.
- Class IIa, e.g. condoms.
- Class IIb, e.g. medical devices for the cleaning of contact lenses.
- Class III, e.g. medical devices integrating medicinal products.
We can help you to find the right category and thus follow the right conformity assessment procedure for your medical product.