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.
The Ministry of Health of Ukraine approved guidelines that are developed on the basis of relevant documents of the European Commission (MEDDEV) for an unambiguous interpretation of technical regulations regarding medical devices, medical devices for in vitro diagnostics and active implantable medical devices. The recommendations are not legally binding, but should be taken into account […]Read more
The program of the event is available only on Ukrainian or RussianRead more
The Ukrainian Scientific Institute of Certification invites you to take part in the 10th anniversary Ukrainian forum of medical device market operators, within the framework of which our specialists will make a report on the topic: “Certification of medical devices during a pandemic: remote audits, recognition of the results of conformity assessment carried out outside […]Read more