About three years ago the first Agreement on recognition of conformity assessment results was signed by notified body TÜV SÜD. This agreement started national conformity assessment of medical devices from the European market in a faster, more economical and transparent way. At the present moment about 30 EU notification bodies have signed such Agreements with Ukrainian designated conformity assessment bodies.
This means that Ukrainian patients and doctors obtain faster access to modern technologies, the final cost of medical devices is reduced and global manufacturers make easier decision to enter Ukrainian market.
Article 45 of Law of Ukraine “On technical regulations and conformity assessment” provides a detailed description of the partial recognition procedure, and a few months ago the text of the article was amended and expanded.
After more than 500 procedures on the conformity assessment of medical devices, medical devices for in-vitro diagnostic and active implantable medical devices with partial recognition route, we have prepared an article in which we share the accumulated experience and answer the most common questions.
In November we will hold a seminar in Russian / Ukrainian language and a webinar in English on the procedure for partial recognition of EC certificates in Ukraine, for preliminary registration please send notification to email@example.com
NB! Copying or reprinting of this material is allowed only with the written consent of the administration of the company “Cratia” and reference to the website https://cratia.ua/