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

11.10.2021

How to make interlaboratory comparisons of test methods

Read more
29.04.2025

What distinguishes medical devices, accessories, components and parts for them?

Read more
14.06.2024

OBL-OEM CONFORMITY ASSESSMENT OF MEDICAL DEVICES Analysis of technical documentation, audits, supervisions and recertification

Read more