Georgia CE Marking Status 2026: Safety Presumption Under the Product Safety and Free Movement Code

1. Key takeaways

CE marking in Georgia is the basis of a presumption of safety, not a pass exempting a product from registration. Its legal status derives from Article 2(3) of the Product Safety and Free Movement Code of Georgia, Law No. 6157-Iს (8 May 2012): products manufactured in conformity with the European new approach directives and the global approach directives are deemed to satisfy the essential safety requirements of the Code. For manufacturers holding CE certificates, this is genuinely good news, because it allows a single conformity evidence package to carry substantial weight in the Georgian market. But the presumption is a conditional benefit, not a blanket entitlement. It attaches to the safety dimension only, it can be rebutted, and it says nothing about registration, labelling language or local distribution requirements. A market entry plan that treats the CE mark as a universal key to Georgia will discover that each of those separate dimensions has its own legal basis, its own authority and its own documentation demands, none of which are satisfied by the certificate alone.

2. Legal basis

1. Product Safety and Free Movement Code of Georgia, Law No. 6157-Iს, dated 8 May 2012.
2. Article 2(1): basic principles of the Code, including point a on state mandatory safety requirements applying only to regulated areas, point b on placing safe products on the market under minimum regulation, point d on priority use of international and European standards in the field of standardisation, and point f on certification and conformity assessment performed according to international and European systems.
3. Article 2(2): the regulatory mechanisms of the Code are product safety assurance, harmonisation of technical standards and reduction of non-tariff trade barriers.
4. Article 2(3): products manufactured in conformity with the new approach and global approach directives adopted or approved by the Council of Europe shall satisfy the essential safety requirements established by the Code.
5. Article 3(1): products manufactured in accordance with the domestic law of countries that have appropriate product safety standards and developed quality infrastructure are placed on the market without restriction within regulated areas; the country list is determined by the Government of Georgia.
6. Article 3(2): where a technical regulation does not establish specific safety requirements, the requirements of Chapters II and III of the Code apply.

3. Expert insights

Insight 1: Article 2(3) operates on a presumption logic, not an exemption logic. The wording of the provision is that such products shall satisfy the essential safety requirements of the Code, meaning that products manufactured in conformity with the European directives are presumed to satisfy the Georgian essential safety requirements. A presumption can be rebutted. Once a product presents a safety problem in Georgia or fails to meet local labelling language requirements, the presumption fails. This is not a theoretical distinction. Market surveillance authorities operate on exactly this footing: the CE certificate opens the analysis, and the actual condition of the product, its documentation and its labelling close it. Companies should therefore maintain the CE technical file in a state of continuous readiness, because the presumption is only as strong as the evidence that can be produced on short notice when an inspector asks for it.

Insight 2: Article 3(1) is the actual unrestricted-entry channel, but it depends on a government list. The paragraph assigns the determination of the list to the Government of Georgia, which means that the question of which countries enjoy unrestricted access is a dynamic administrative decision. When assessing the market, a company should verify whether the country of origin is on the current list and should not assume that EU manufacture automatically equals unrestricted entry. The list should be checked at project start and re-checked before any shipment, with the version and the query date recorded in the compliance file, because a change in the list can alter the import conditions for an entire supply chain without any change in the product itself.

Insight 3: Article 3(2) is both a fallback clause and a risk clause. Where a technical regulation does not establish specific safety requirements, the general requirements of Chapters II and III apply. Because dedicated technical regulations for medical devices in Georgia are still under development, in actual operation a large share of products falls precisely within this fallback zone, and this is exactly the institutional space in which the classification confirmation letter operates. Products relying on the fallback carry the full general safety obligations of the Code, so their internal safety assessment and labelling compliance deserve the same rigour as a registered product would receive, even though no dossier is filed anywhere.

4. Practical recommendations

1. Submit the CE certificate as the core document of the safety evidence package, but do not claim an exemption from registration on that basis; pathway determination must return to Article 11⁴.
2. Verify whether the country of origin is on the current list of the Government of Georgia, and archive the list version and the query date.
3. Georgian language requirements for labels and instructions for use are independent of CE compliance and must be prepared separately, so that the presumption of safety is not rebutted by localisation defects.
4. Distinguish the two concepts of presumption of safety and marketing authorisation in internal compliance documents, to prevent misreading on the sales side.

5. Verification checklist

• □ Distinguished the two legal effects of presumption of safety and marketing authorisation in the documentation
• □ Verified whether the country of origin is on the current government list and recorded the version
• □ CE certificate within its period of validity and covering the declared models
• □ Georgian language labels and instructions for use completed
• □ Authentic text of Articles 2 and 3 of the Code archived together with the verification date

GRZAN international services — GRZAN advises on the legal effect of CE marking in Georgia, origin country list verification and localisation of labelling under the Product Safety and Free Movement Code. For enquiries about this guide, contact info@grzanglobal.com.

Regulatory information verified as of October 30, 2026