Ukraine desk
Regulatory support for medical and IVD devices, electrical equipment in Ukraine — from the technical file and conformity assessment to national registration.
TR — Ukrainian technical regulation.
Who we help
You make the product, or you advise the manufacturer and need a Ukraine desk. Companies come from anywhere — not only Europe. The product can be a medical device, an IVD, or electrical equipment. A CE certificate is not required for Ukrainian registration, but may be a benefit.
We handle the regulatory work: the Ukrainian technical file, the local and legal papers, labelling for Ukraine, the declaration of conformity, a designated body if the class needs one, and the national register for medical devices and IVD. We answer the reviewer and close the comments, through to the product being placed on the market.
You keep the client, wherever they are. We can work under your brand: the Ukrainian file, the designated body, and correspondence with the reviewer — unless you want us to speak to the manufacturer directly.
How a project starts
Tell us what the product is and send us any CE certificates, declarations, labels or instructions you already have. You don't need a complete technical file to get started.
We review the documents against Ukrainian requirements and identify what is missing.
We assemble the technical dossier, prepare the local documents and the necessary legal papers.
We prepare labeling for the Ukrainian market.
Where required, we submit the file to a designated body, finalize the declaration of conformity, and arrange entry into national registers.
About
Around ten years of regulatory work on the Ukrainian market, covering medical devices and IVD under TR 753, 754 and 755, as well as electrical and electronic equipment.
Most of the work is practical conformity assessment: preparing the Ukrainian technical file, local documents and labelling, then handling the declaration, designated body where required, reviewer comments and, for medical devices and IVD, national registration.
Areas of work
The working approach is the same. The applicable regulations, documentation and submission requirements are covered on each product page.