Ukraine has approved new Technical Regulations on medical devices and in vitro diagnostic medical devices based on the MDR and IVDR

On 10 June 2026, the Cabinet of Ministers of Ukraine approved:

• the Technical regulation on medical devices (Resolution of the Cabinet of Ministers of Ukraine No. 759), developed based on Regulation (EU) 2017/745 (MDR);
• the Technical regulation on in vitro diagnostic medical devices (Resolution of the Cabinet of Ministers of Ukraine No. 758), developed based on Regulation (EU) 2017/746 (IVDR).

The adoption of these acts is the next stage in aligning Ukrainian legislation with European Union legislation in the field of medical devices. Once the new Technical regulations become applicable, they will replace the current Technical regulations No. 753, No. 754 and No. 755, developed, respectively, based on the MDD, IVDD and AIMDD Directives.

The MDR and IVDR requirements are mirrored in the new Regulations; however, they will be implemented through national legislation and the national technical regulation infrastructure. In particular:

• a non-resident manufacturer, including one from the EU, must appoint an Authorised representative in Ukraine;
• manufacturers, Authorised representatives and importers must register in the National medical devices database;
• labelling and instructions must be provided in Ukrainian;
• for conformity assessment, national procedures must be applied and Ukrainian designated bodies must be involved, while compliance with the requirements is confirmed by a national declaration of conformity and, where applicable, a certificate of conformity;
• labelling and instructions must bear the national conformity mark;
• state market surveillance is carried out by the state control authority.

Transition period

Resolutions No. 758 and No. 759 enter into force six months after the date of their publication – on December 18, 2026, while the new Technical regulations become applicable from December 31, 2030. This four-year transition period is intended for the adoption of secondary legislation, creation of electronic systems and other infrastructure, designation of conformity assessment bodies, and preparation of businesses. The Resolutions include schedules of implementation measures.

From December 31, 2030, Technical regulations No. 753, No. 754 and No. 755 will cease to have effect, while conformity assessment documents will remain valid and will allow medical devices to be placed on the market for a further 12 months, provided that the documents themselves remain valid, the device has not undergone significant changes, and it does not present an unacceptable risk.

The exception is ordinary class I medical devices that are not sterile, do not have a measuring function and are not reusable surgical instruments, as well as non-sterile class A IVDs. To be placed on the market, such devices must comply with the new requirements.

Medical devices that comply with the requirements of Technical regulations No. 753, No. 754 and No. 755 and were placed on the market before the end of the relevant transition period may continue to be made available on the market and put into service until the end of their shelf life.

New classification rules

The classification of medical devices in Ukraine under the new Technical regulations is being aligned with the MDR and IVDR classification systems.

For medical devices, the division into classes I, Is, Im, IIa, IIb and III is retained, while a new class Ir (devices intended for reuse) is introduced. Separate rules are established, in particular, for software, substance-based devices, nanomaterials, inhalation devices and reusable surgical instruments.

Technical regulation No. 759 also applies to certain groups of products without an intended medical purpose: coloured contact lenses, equipment for the reduction or removal of adipose tissue, high-intensity electromagnetic equipment for skin treatment, hair removal or tattoo removal, as well as certain equipment for brain stimulation.

For IVDs, a risk-based classification into classes A, B, C and D is introduced. The involvement of a designated body will be mandatory for devices in classes B, C and D, as well as for sterile class A devices.

As a result of the new classification, a significant proportion of IVDs that, under the current Technical regulation No. 754, are declared without the involvement of a conformity assessment body may move to classes B, C or D. Such devices will require conformity assessment involving a designated body, expanded technical documentation, and a manufacturer audit or recognition of an EU certificate.

Conformity assessment bodies

Conformity assessment will be carried out by Ukrainian bodies designated to perform procedures under the new Technical regulations and meeting specific requirements for personnel, competence, clinical expertise, quality management systems, etc. A current designation under Technical regulations No. 753, No. 754 or No. 755 does not confer the right to conduct conformity assessment under the new acts.

Recognition of conformity assessment results obtained in the EU

The mechanism for recognition of foreign conformity assessment results established by Article 45 of the Law of Ukraine “On technical regulations and conformity assessment” will continue to apply to the new Technical regulations.

A Ukrainian designated body applies the relevant Ukrainian procedure or part thereof and, on the basis of an agreement with an EU notified body, is entitled to recognise the results of the work performed by that notified body, including an audit report. Since 2016, this mechanism has introduced a simplified and transparent procedure that reduces duplication of audits, accelerates market access for products, and promotes cooperation between Ukrainian and European conformity assessment bodies.

Technical documentation, post-market surveillance and labelling

The new Technical regulations significantly expand the requirements for technical documentation and control of the device throughout its entire life cycle. For medical devices, the requirements include clinical evaluation, post-market clinical follow-up (PMCF), a post-market surveillance (PMS) plan and documentation, and periodic safety update reports (PSUR). For IVDs, similar requirements cover performance evaluation, post-market performance follow-up (PMPF) and PSUR. For high-risk devices, public summaries of safety and clinical performance, or of safety and performance, are provided for.

As under the current Technical regulations, labelling and instructions for use under the new Regulations must be provided in Ukrainian. Symbols must be internationally recognised and comply with applicable national standards or common specifications approved in Ukraine. If there is no relevant standard or common specification, the symbols and colours used must be described in the documentation accompanying the device.

The Technical regulations do not establish requirements for translation of the original technical file or its parts into Ukrainian, but, as before, additional requirements may be imposed by conformity assessment bodies depending on the qualifications of their personnel. During an inspection, the state market surveillance authority may request a Ukrainian translation of the necessary documents, for which, under the Law of Ukraine “On state market surveillance and control of non-food products”, a period of up to 30 working days is provided.

The declaration of conformity must be drawn up in the state language and contain, in particular, the Basic UDI-DI of the relevant device or group of devices.

National medical devices database and SRN

The new Technical Regulations provide for the creation, by December 2029, of a National Medical Devices Database compatible with the European EUDAMED database. Its architecture must include seven interconnected electronic systems (modules):

• registration of medical devices and IVDs;
• the UDI database;
• registration of economic operators;
• designated bodies and certificates;
• clinical investigations and performance studies;
• device vigilance and post-market surveillance;
• state market surveillance.

Manufacturers, Authorised representatives and importers must register in the electronic system and obtain a Single Registration Number (SRN). For devices whose conformity assessment requires a designated body, the registration data are entered into the system before the application is submitted. The manufacturer uses the SRN in its application to the designated body and to access the National Database.

This is a separate number in the national system. The new Technical regulations do not provide for automatic transfer or reuse of an SRN obtained in EUDAMED. The economic operator’s data must be updated within seven calendar days after a change, confirmed one year after the initial registration, and thereafter every two years.

Manufacturer’s Authorised representative

A non-resident manufacturer may place devices on the market in Ukraine only if it appoints an Authorised representative that is resident in Ukraine. The written mandate must be accepted by the Authorised representative and cover at least all devices of one generic device group.

The new Technical regulations establish new obligations for the Authorised representative. In particular, it must:

• fulfil its own registration obligations (SRN) and verify the manufacturer’s compliance with the requirements concerning UDI and device registration;
• verify the availability of the declaration of conformity and technical documentation and that the appropriate conformity assessment procedure has been carried out;
• keep copies of the declaration and certificates and ensure continuous access to the necessary technical documentation, provide documents to the state market surveillance authority, forward requests for samples to the manufacturer, and cooperate during corrective actions;
• immediately forward complaints and reports of possible incidents to the manufacturer;
• terminate the mandate if the manufacturer breaches its obligations and notify the market surveillance authority and, where necessary, the designated body.

The Authorised representative must permanently and continuously have at its disposal at least one person responsible for regulatory compliance (PRRC), with the education and experience specified by the Technical regulation.

Importers

The importer is defined as a separate economic operator and assumes new obligations, including:

• register in the National Database, obtain its own SRN, and add its details to the medical device registration record;
• be indicated on the labelling or in the accompanying documentation;
• before placing a device on the market, verify the presence of the conformity mark and declaration of conformity, identification of the manufacturer and the presence of an Authorised representative, compliance of the labelling, availability of the instructions for use and UDI, where applicable, and registration of the device in the electronic system;
• ensure the storage and transport conditions specified by the manufacturer, keep records of complaints, non-compliant devices, withdrawals and recalls, forward incident reports to the manufacturer and the Authorised representative, keep the declaration and certificate, cooperate with the market surveillance authority, and provide samples or access to the device.

Unique device identification system

The new Technical regulations introduce a UDI system for unambiguous identification of devices and their traceability in the supply chain. UDI consists of two main elements:

• UDI-DI – a device identifier unique to a specific manufacturer and device model or version and linked to the registration data;
• UDI-PI – a production identifier containing variable production data, for example, a lot number, serial number, manufacturing date or expiry date.

The Basic UDI-DI is a top-level key for a device model or group of devices. It is used in technical documentation, the declaration of conformity, certificates, public summaries and registration records. Unlike the UDI carrier of a specific trade unit, the Basic UDI-DI is generally not placed on the label.

Before placing a device on the market, the manufacturer must assign a UDI to the device and, where applicable, to all higher levels of packaging, enter the UDI-DI and key data in the UDI database, and maintain a list of all assigned codes in the technical documentation. The UDI carrier is placed on the device label and on all higher levels of packaging, except shipping containers. For specified categories of devices, the Basic UDI-DI must be assigned before an application is submitted to the designated body and is included in the certificate.

The Ministry of Health must designate one or more UDI issuing entities. The action plan provides for approval of the procedure for their designation and creation of the UDI system by December 2027, and the actual designation of such entities by December 2028.

State market surveillance

The texts of the new Technical regulations designate the State Service of Ukraine on medicines and drugs control as the state market surveillance authority. It must be empowered to inspect not only labelling and the declaration, but also technical, clinical and post-market documentation, conduct physical and laboratory inspections, obtain samples, inspect economic operators, suppliers and subcontractors, and require corrective actions, withdrawal or recall of products.

At the same time, Resolution of the Cabinet of Ministers of Ukraine No. 739 of 4 June 2026 established the Ukrainian Pharmaceutical Agency (UPA) and provides for the dissolution of the State Service of Ukraine on medicines and drugs control. The UPA is designated as the legal successor and the authority whose powers will include market surveillance of medical devices and IVDs. The actual transfer of functions must take place after the Cabinet of Ministers of Ukraine adopts a separate act confirming the UPA’s readiness to exercise the relevant powers.

Information on inspections, non-compliances, risks, withdrawals, recalls and other measures must be entered into the relevant module of the National Database.

Cratia actively participated in the expert review and public discussion of the drafts of both new Technical Regulations and continues to monitor the development of the regulatory and technical infrastructure. We have long been working with the MDR and IVDR requirements in procedures for the recognition in Ukraine of conformity assessment results and certificates issued by EU notified bodies.

We will be pleased to offer:

• analysis of the impact of the new requirements on the device portfolio and preparation of a transition roadmap;
• preparation of national documents and forms, support for conformity assessment procedures in Ukraine, including recognition of conformity assessment results and MDR/IVDR certificates;
• services as an independent Authorised representative of the manufacturer in Ukraine.

If you have any questions or would like to discuss cooperation, please contact us at info@cratia.ua or +38 068 064 78 31.