Labeling, Instructions for Use and the EAEU Circulation Mark

1. Key takeaways

On the national Russian path, labelling and instructions for use must comply with the requirements of Resolution No. 1684 for operating documents and marking and must be in Russian. On the Union path, they must additionally comply with EEC Decision No. 27 on general safety and effectiveness requirements and the requirements for marking and operating documents, and must bear the special medical device circulation mark of the Union market established by EEC Decision No. 26. The two sets of requirements are cumulative: a product registered on the Union path and circulating in Russia must satisfy both the Russian-language requirements and the Union requirements at the same time.

For packaging and documentation teams this means the artwork process has a regulatory dimension from the very first draft. Colour photographs of labels and packaging, interface images for software and the circulation mark artwork all form part of the registration file, and any later change to a field on the label is a potential change project under the registration rules rather than a simple print correction. Companies that place labelling under change control early avoid the common situation where a marketing-driven packaging update silently invalidates the registered documents.

The practical starting point is an inventory of every marking element and every instruction field, mapped to the requirement that governs it on each path. For a Union-path product this inventory has two columns, one for the national requirements and one for the Union requirements, and any element covered by both is checked against the stricter wording. The inventory then becomes the master document for artwork reviews: designers, translators and regulatory staff all work from the same list, and nothing reaches the printing house without being reconciled against it.

2. Legal basis

The instruments governing labelling, instructions for use and the circulation mark are summarised below.

3. Expert insights

Insight 1: the label is part of the registration dossier, not a printing step. Resolution No. 1684 requires the submission of colour photographs containing the label and packaging, with dimensions of at least 18 × 24 centimetres, and for software also colour images of the electronic media and the software interface. A physical product that does not match the approved artwork equals a non-conforming dossier. This connection between print reality and regulatory file is often underestimated by marketing teams, who treat packaging revisions as commercial decisions. In Russia the registered artwork is the reference, and the printed product must follow it.

Insight 2: deficiencies in instructions and labelling enter the adverse event assessment. Order No. 540n brings situations such as users being unable to understand how to use the device safely, incomplete or contradictory instructions, missing important warnings, and labels on which the model or batch cannot be identified into the evaluation of adverse events. The consequence of poor translation quality is thus quantified at the regulatory level: an unclear Russian IFU is not merely a customer-experience defect but a monitoring finding. Professional native-speaker review of warnings, contraindications and handling steps is a compliance measure, not a cosmetic one.

Insight 3: the mark requirements differ between the two paths. The national path has no separate mark requirement, while the Union path requires the special circulation mark under Decision No. 26, which is distinct from the EAC conformity mark. Misusing the mark, or applying the EAC mark where the medical device circulation mark is required, creates additional explanation costs at customs clearance and in public procurement. The mark artwork and its usage rules should therefore be fixed at the packaging design stage together with the Russian-language label content.

Translation is the place where most labelling defects are born. A term that is correct in general Russian may be wrong in the device context, and an instruction that reads fluently may still be unexecutable at the point of care. The review that matters is therefore performed by someone who both speaks Russian natively and understands the clinical use of the product, and it verifies not grammar but actionability: whether the stated steps, warnings and contraindications can actually be followed by the intended user. Building this review into the artwork timeline, with room for a second iteration, is cheaper than correcting labels after a monitoring finding.

4. Practical recommendations

1. Bring label artwork management under change control: evaluate any change of a field first for whether it requires a change filing under the registration rules.
2. For Union-path products, prepare the circulation mark artwork in vector form together with usage instructions, and finalise it during packaging design.
3. Subject the Russian instructions for use to native-speaker review before finalisation, focusing on the executability of contraindications, warnings and handling steps.
4. Produce and archive the colour photographs of labels and packaging in the required format, and for software the interface images, as part of the dossier set.
5. Check the translated terminology against the registered device name and intended use, so that the label, the IFU and the dossier speak one language.

5. Verification checklist

• □ The Russian label artwork matches the colour photographs submitted in the dossier
• □ Software products have provided images of the electronic media and the interface
• □ Union-path products correctly use the circulation mark under Decision No. 26
• □ The instructions for use have passed native Russian-language review
• □ Any change to labels or instructions goes through the change review process

Regulatory information verified as of October 29, 2026.

GRZAN supports manufacturers in preparing labelling and instructions for use for the Russian market, from Russian-language artwork and native-speaker review of IFU content to the correct application of the EAEU circulation mark and the alignment of packaging with the registered dossier. Our team helps you keep print reality and regulatory documentation in exact correspondence. For support with labelling and IFU compliance in Russia, contact us at info@grzanglobal.com.