Conformity assessment of medical devices

A medical device cannot be placed on the market in Ukraine without conformity assessment against the technical regulation. We determine the risk class of the device, select the conformity assessment procedure and arrange the declaration or certificate. The service is for companies and sole proprietors across Ukraine — Kyiv, Odesa, Kharkiv, Dnipro.

Medical devices and technical regulations

Medical devices are regulated by three technical regulations approved by Cabinet resolutions of 02.10.2013: No. 753 — general, No. 754 — for in vitro diagnostics, No. 755 — active implantable. The regulations are harmonized with EU legislation.

Risk classes

Class	Characteristics
I	Low risk; self-declaration possible
IIa	Medium risk; with an assessment body
IIb	Increased risk; with an assessment body
III	High risk; full assessment with a body

Self-declaration or conformity assessment body

The assessment procedure depends on the class. For Class I devices (non-sterile, without a measuring function) self-declaration is enough: the manufacturer or authorized representative draws up a declaration without involving an assessment body. For classes IIa, IIb and III a conformity assessment body is involved, which issues a certificate.

Quality management system and technical file

Conformity assessment relies on a quality management system under DSTU EN ISO 13485:2018 and technical documentation (technical file). The file fills in the list of essential requirements from Annex 1 of the specific regulation. This set is the basis for the declaration.

Declaration of conformity and national mark

The declaration of conformity gives the right to place the device on the market and into use. The national conformity mark (a trefoil inside the letter “C”) is applied to the labelling. For imported devices the mark is best applied before the cargo is shipped to Ukraine.

Authorized representative in Ukraine

If the manufacturer is foreign, they need an authorized representative in Ukraine. The representative keeps the documentation, provides access to it for state supervision authorities and is responsible for interaction with them. Market surveillance of medical devices is carried out by the State Service on Medicines.

In vitro and active implantable devices

For in vitro diagnostic devices (test systems, reagents) regulation No. 754 applies, and for active implantable ones (pacemakers and similar) — No. 755. Each group has its own assessment features, so correctly assigning the device to a regulation is the first step.

Medical devices and medicines — different regimes

A medical device undergoes conformity assessment against the technical regulation, not state registration like a medicine. If the goods are on the border between categories, we first determine their status — this affects the whole set of documents; a separate regime applies to medicines and dietary supplements.

Import and documents for customs

The declaration or certificate goes to customs together with the invoice, foreign-trade contract and technical documentation. Medical devices are part of technical regulation, so questions of conformity assessment are handled together with product certification. The UKT ZED code selection helps determine the goods code, and clearance is handled by the customs broker.

How we carry out conformity assessment

Classification

We determine the regulation and risk class of the device.
Technical file

We assemble the documentation and ISO 13485 confirmation.
Conformity assessment

Self-declaration or an assessment body — depending on the class.
Mark and customs

We apply the national mark and clear the shipment.

Frequently asked questions