Certification of medical devices

Certification of Medical Devices – a procedure that involves assessing the conformity of medical devices to standards and requirements established by legislation. This is a necessary step before placing medical devices on the market.

Сertification is carried out by independent organizations – conformity assessment bodies that have the necessary authority and competence and are accredited by the state to conduct conformity assessments of medical devices according to legislative requirements. These certification organizations may have varying levels of authority, ranging from technical evaluations to full testing and auditing of the manufacturer.

Тhe procedure during which an authorized body (in Ukraine, a Conformity Assessment Body) formally confirms that medical devices meet the standards (e.g., ISO 13485:2016 and Technical Regulation No. 753).

А certificate of conformity is a document that confirms that a medical device complies with legal requirements and can be placed on the market. The certificate may be issued for a specific medical device or for a group of devices with similar technical characteristics.

Сertification of medical devices is an important procedure that ensures the safety and effectiveness of medical devices for patients and healthcare professionals. It also enables manufacturers to ensure market access, enhance competitiveness, and expand business opportunities.