Recognition of a certificate

Certification of medical devices without on-site visits through the recognition of European certificates issued by European notified bodies.

This is possible under Article 45 of the Law of Ukraine on Technical Regulations and Conformity Assessment, provided that Ukrainian notified bodies have agreements with European notified bodies.

Recognition of certificates is a procedure through which a Ukrainian body can accept a certificate of conformity issued by a European notified body. This process is intended to simplify trade and ensure the safety and quality of products crossing borders.

To recognize medical device certificates, the Ukrainian body must have a corresponding agreement with the European notified body. Not all Ukrainian bodies have such agreements. The most prominent bodies for certificate recognition are Unicert and Improve Medical.

In the European Union, this is implemented through the Mutual Recognition System, which allows manufacturers to obtain a single certificate of conformity in any EU country, which is then automatically recognized in other EU countries.