Labeling of medical devices intended for showing, demonstrations at the place of fairs, exhibitions.

Other news

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 […]

24.09.2020

Stand-alone software as a medical device: Features of its classification and conformity assessment

Journal “Standardization, certification, quality” № 4 (122)/2020 Over the past decades, the frequency of using software in various areas of human life has increased significantly. In particular, this product has taken an important place in the medical industry. For example, as an integral part of a medical device (software incorporated in medical devices or pacemaker […]

25.06.2020

Features of the classification. Medical devices on the border of definitions.

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