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Conformity assessment consulting

Medical Devices: Conformity Assessment Procedure and Conformity Mark

The conformity assessment is a procedure conducted by the manufacturer, indicating whether a specific product conforms to all technical regulations. It is a common practice, and Ukraine, as a WTO member, follows the established rules and brings its legislation in compliance with that of Europe.

A few years ago, Ukraine adopted technical regulations (regarding the area of medical devices) developed based on the relevant European Directives. Nevertheless, similarly to the product launch at local markets, the medical device introduction on the Ukrainian market has its peculiarities. For instance, the CE Mark on the packaging of a medical device does not entitle the manufacturer to place the products on the Ukrainian market.

Do you have an interest in entering the Ukrainian market of medical devices?

Do you want to know more about the steps for launching a new product on the market and get further information regarding the local authority requirements for new goods?

Do you wonder how to be assessed for conformity and bring your product to the market promptly?

JERELO is qualified to provide all the specifics and peculiarities of how to start supplying medical devices in Ukraine, assist you in choosing the right conformity assessment procedures and the Conformity Assessment Body.

We provide efficient solutions to such widespread queries from manufacturers as the following:

  • How to determine the class of a medical device and choose the proper conformity assessment procedure?
  • How to choose the most cost-effective option for conformity assessment to obtain the conformity mark?
  • How long does it take to complete the medical device launching procedure on the Ukrainian market?
  • What factors can influence the success of the conformity assessment procedure?
  • How to optimize the medical device launch process in the Ukrainian market?

If you need answers to any of the questions above, do not hesitate to contact us!

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