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

25.09.2023

The XVIII Specialized Conference BEAUTY TECH. INNOVATIONS IN PRODUCTION: RAW MATERIALS AND TECHNOLOGIES took place

Read more
24.06.2026

ISO 13485: Key features of the standard for medical device manufacturers

Read more
30.05.2022

The Pharmacy weekly has published a review article about the seminar “Relevance of medical device conformity assessment through EC-certificates recognition during martial law”

Read more