Informing about changes to the conformity assessment body

10.12.2019

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.

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 […]

EU certificate for medical devices: the thorny path of recognition

ThePharmaMedia The first independent pharmaceutical business portal. The text of the article is available only in Ukrainian

Features of the production of sterile medical devices. Clean rooms.

PharmaTechExpo Journal №1-2, 2020. The text of the article is available only in Ukrainian