Medical devices: conformity assessment procedure and the Conformity mark
Conformity assessment is the process carried out by the manufacturer of demonstrating whether specified requirements relating to a product have been fulfilled.
Having joined the WTO, Ukraine has undertaken to implement European legislation, in particular with regard to medical devices. In other words, on the basis of the relevant European Directives, the so-called the Technical Regulations, approved by Cabinet of Ministry of Ukraine, were developed and implemented in Ukraine.
Ready to sell your medical devices in Ukraine? How to conform with the legal requirements for placing medical devices on Ukrainian market?
First, you must comply with Ukraine’s medical device regulations. There are many ways to demonstrate your compliance – also known as conformity assessment routes. The conformity assessment route depends on the classification of the device.
REGCONSULT provides consulting services for manufacturers of medical devices and help with:
• How does device classification dictate the conformity assessment route?
• Are some routes more cost effective?
• What is the fastest route to achieve Conformity Marking?
• What factors should I consider when choosing a conformity assessment route?
• How does my chosen route affect my business?
We answer all of these questions and many more. Please, contact to us.
If you need to speak to someone right away, you can call us at +380 44 3531835Fields marked by asterisk (*) are required