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

04.09.2023

The 12th Ukrainian Forum of Medical Devices Market Operators was held

Read more
28.11.2024

Medical device or medicinal product?

Read more
27.11.2023

Contract manufacturing: requirements are becoming more stringent

Read more