Kyrgyzstan General Safety and Performance Requirements: Decision No. 27 and the Conformity Evidence Table

1. Key takeaways

For general safety and effectiveness requirements, Kyrgyzstan explicitly references Decision No. 27 of the Council of the Eurasian Economic Commission, dated February 12, 2016, on the General Requirements for the Safety and Effectiveness of Medical Devices, and the Requirements for Their Marking and Operational Documentation, with the exclusion of item 63. The reference is contained in paragraph 2 of Article 2 of Cabinet of Ministers Resolution No. 513. The practical consequence is that the conformity evidence table must be built on the item structure of Decision No. 27, with item 63 marked separately as not applicable. Reusing the numbering of the EU MDR Annex I or of national standards produces a confused cross-reference that reviewers cannot follow, and typically triggers clarification requests that delay acceptance.

2. Legal basis

1. Resolution No. 513 of the Cabinet of Ministers, dated August 27, 2024, paragraph 2 of Article 2: safety and effectiveness requirements are imposed in accordance with the General Requirements for the Safety and Effectiveness of Medical Devices, and the Requirements for Their Marking and Operational Documentation, approved by Decision No. 27 of the Council of the Eurasian Economic Commission dated February 12, 2016, with the exception of item 63.
2. Resolution No. 513, paragraph 1 of Article 2: classification follows Board Decision No. 173 of the Eurasian Economic Commission dated December 22, 2015.
3. Resolution No. 513, paragraphs 3, 4 and 5 of Article 2: biological effect evaluation, technical testing, and clinical and clinical laboratory trials reference Decisions No. 38, No. 28 and No. 29 respectively.
4. Annex 1 to Resolution No. 513, Article 2: defines verification and validation.
5. The full text of Decision No. 27 (February 12, 2016) is published on the website of the competent authority.

3. Expert insights

Insight 1: Decision No. 27 governs both safety-effectiveness and marking and operational documentation, making it a dual-content document.

The full title covers the general requirements for safety and effectiveness of medical devices and the requirements for their marking and operational documentation. This means the technical requirements for labeling and instructions for use sit inside the same document, rather than being scattered across several instruments. When drafting labels and instructions for use, companies should return to Decision No. 27 to find the corresponding requirements (see article 30 of this series) instead of relying on EU practice or national habits. Building the labeling checklist from the same source as the conformity evidence table keeps the entire technical file internally aligned.

Insight 2: The exclusion of item 63 is a deliberate reservation within the reference.

Paragraph 2 of Article 2 states expressly that item 63 is excluded. As a matter of legislative technique, such exclusions usually indicate that the conditions for applying that item in Kyrgyzstan are not yet in place, or that it conflicts with other national provisions. When compiling the conformity evidence table, list every item of Decision No. 27 and mark item 63 separately as not applicable, citing paragraph 2 of Article 2 of Cabinet Resolution No. 513 as the legal basis. This practice prevents both the omission of other items and the waste of preparing evidence for a requirement that does not apply.

Insight 3: The conformity evidence table is the most practical deliverable of this topic.

We recommend a table with five columns: the item number of Decision No. 27; a summary of the requirement; an applicable or not applicable determination; the method of conformity (standard, test or design characteristic); and an index to the evidence document. This table is the common language between the reviewer and the company: it decomposes the bare statement that the product complies into an item-by-item chain of verifiable evidence. Reviewers can locate support instantly, and deficiency letters, when they do come, are narrower and faster to answer.

Insight 4: The definitions of verification and validation dictate how the method of conformity is written.

Article 2 of Annex 1 to Resolution No. 513 defines verification (confirming that specified requirements have been fulfilled) and validation (confirming that requirements for a specific intended use or application have been met). In the method-of-conformity column, the two approaches should be clearly distinguished: demonstrating through inspection or testing that specified requirements are fulfilled is verification; demonstrating through clinical or simulated-use evidence that requirements for the specific use are met is validation. Mixing the two makes it difficult for the reviewer to judge the strength of the evidence offered.

Insight 5: The integrity of the five referenced technical rules is the source of transferability.

Article 2 of Resolution No. 513 references Decisions No. 173, 27, 38, 28 and 29 in a single provision. Technical documentation prepared on the national track therefore shares its underlying rules with the Union track. This is exactly what article 11 of this series emphasized: evidence prepared on the national track can, for the most part, be reused when migrating to the Union track after 2028. Companies should build this in from the start, preparing evidence in a rule-oriented rather than case-oriented format, so that migration later becomes a repackaging exercise instead of a re-testing exercise.

4. Practical recommendations

First, obtain the current text of Decision No. 27 and build the evidence table on its item numbers. Do not carry over the numbering of the EU MDR Annex I or of GB/T series standards; use the items of Decision No. 27 directly as the rows of the table so the mapping is unambiguous.

Second, mark item 63 separately as not applicable and state the legal basis. We recommend the table include an explicit note: under paragraph 2 of Article 2 of Cabinet of Ministers Resolution No. 513 dated August 27, 2024, item 63 of Decision No. 27 does not apply.

Third, distinguish verification from validation in the method-of-conformity column. Add a column identifying the method type for each item. This small addition sharply increases the alignment between the evidence table and the statutory definitions and reduces reviewer questions.

Fourth, source the labeling and instructions-for-use requirements from Decision No. 27 itself. Extract the items on marking and operational documentation into a standalone labeling checklist (see article 30 of this series) so label design starts from the binding text rather than from assumptions.

Fifth, make the evidence table rule-oriented. Record the referenced Union decision numbers alongside each item, so that migration to the Union track after 2028 has a prepared interface and does not require reconstructing the evidentiary logic from scratch.

5. Verification checklist

• □ Current full text of Decision No. 27 of the Council of the Eurasian Economic Commission (February 12, 2016) obtained;
• □ Conformity evidence table built on the item numbering of Decision No. 27, with five columns (item number, requirement summary, applicability determination, method of conformity, evidence index);
• □ Item 63 marked as not applicable in the table, citing paragraph 2 of Article 2 of Resolution No. 513 as the basis;
• □ The method-of-conformity column distinguishes verification and validation;
• □ Labeling and instructions-for-use requirements verified against Decision No. 27 and captured in a standalone checklist;
• □ The evidence table records the referenced Union decision numbers, preparing the interface for post-2028 migration.

Regulatory information verified as of October 29, 2026.

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