Recognition of EU certificates for medical devices in Ukraine. Simplification, shortening of term and reduction of costs for conformity assessment with the requirements of Technical Regulations.

10.12.2019

Since the Technical Regulations entered into force, discussions on the possibility of simplifying conformity assessment procedures, especially for medical devices of high-risk classes have been underway. Recently, we have had positive and relevant news regarding the recognition procedures in Ukraine for certificates of conformity issued by some notified bodies, accredited in the EU. To put it simply – the recognition of EU certificates for medical devices.

Full text of the article

Other news

01.06.2026

Training of medical device manufacturers' personnel as part of the quality system

Read more
10.03.2026

A contract on recognition of the results of the assessment of conformity with DNV MEDCERT GmbH (NB #0482)

Read more
10.09.2019

Recognition of EU certificates for medical devices in Ukraine

Read more