In addition, All medical devices are classified according to the following criteria: invasiveness (non-invasive (medical devices and equipment that do not require penetration into the human body for diagnosis, monitoring or treatment), invasive (fully or partially introduced into the human body through its surface or body opening), durations use (temporary (for continuous use up to 60 minutes), short-term (for continuous use for up to 30 days) and long-term (for continuous use for a period of 30 days or more),  availability of contact (contact, non-contact) with the human body, by action on vital human organs, as well as the possibility of use of energy sources together with the product.

Regardless of the class, medical devices must meet the basic requirements, including the provision of information to be supplied by the manufacturer, be subject to reporting requirements under the medical device control system and be labelled with a conformity mark.

The manufacturer of medical devices or a person authorised by the manufacturer may independently determine the class of medical device, if necessary, the conformity assessment body (CAB) or (the Ministry of Health of Ukraine) confirms the correctness of determining the class of medical device.

Confirmation letter risk class from VERIFICA LLC is an official response from the authorised body (after receiving NAAU accreditation) on conformity assessment on the belonging of a medical device to a particular class.

The specialists and experts of VERIFICA LLC will prepare a letter of confirmation of the class of medical devices at your request within a short time.

Self-declaration - is a separate independent internal control procedure for the production of medical devices, through which the manufacturer or its authorised representative ensures and confirms the compliance of medical devices with the requirements of the Technical Regulations.