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it is a modern competent body, that fulfills all aspects of Ukrainian legislation and is guided by EU law. The body is fully independent and impartial in its decisions which are based solely on objective evidence of conformity. We have much to be proud of:
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Since 1 July 2015, it has been a mandatory requirement that medical devices, before being placed on the Ukrainian market and/or put into service, must be subject to the assessment of conformity with the Technical regulations (TR) (approved by Resolutions No. 753, 754, 755 of the CMU of 2 October 2013). Clause 21 of Resolution No. […]
Read moreThe presence of a certified Quality Management System (QMS) provides the company with a number of advantages: The efficiency and effectiveness of processes are optimized and increased; The quality of products and/or services improves; The company becomes one that independently improves and develops, requires less attention from the company’s management; The effectiveness of decision-making increases; […]
Read moreby more than 350 international medical device manufacturers since:
Manufacturers operating under the (EU) 2017/745 Medical Device Regulation (MDR) and (EU) 2017/746 In Vitro Diagnostic Regulation (IVDR) are required to utilise the European Medical Device Nomenclature (EMDN) for regulatory submissions, device registration in EUDAMED, and sampling. To support consistent and compliant application, MedTech Europe released a practical guide for the use of the […]
Read moreThePharmaMedia The first independent pharmaceutical business portal. The text of the article is available only in Ukrainian
Read moreThePharmaMedia The first independent pharmaceutical business portal. The text of the article is available only in Ukrainian
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