Measurement laboratory

Definition of the CF class:

Before starting the certification process, the manufacturer must determine whether the product is a medical device or an auxiliary product to such a medical device, as well as the medical purpose and intended use.

Criteria and principles of classification of medical devices are determined by Annex 2 of the Technical Regulation on Medical Devicesapproved by the CMU Resolution No. 753 dated 02.10.2013.

Medical device - is any instrument, apparatus, device, device, software, material or other product intended for the diagnosis, treatment, prevention of the human body and (or) ensuring such processes

The following types of medical devices are distinguished by their safety level:

class I

- low risk share;

class IIa

- average risk share;

class IIb

- Increased share of risk;

class III

- high risk share.