Georgia Medical Device Technical File: Four Localisation Steps for EU Documentation

1. Key takeaways

EU technical documentation cannot be forwarded to Georgia unchanged. It must pass through 4 localisation steps: language and notarisation; local adaptation of intended use and target population; local accessibility of the referenced standards; and a Georgian version of the labelling and instructions for use. The legal anchor is the Product Safety and Free Movement Code, Law No. 6157-Iს of 8 May 2012, Article 3(2), which provides that where a technical regulation does not specify particular safety requirements, Chapter II and Chapter III of the Code apply.

The practical significance of Article 3(2) is that a large share of medical devices currently falls exactly into the gap where no dedicated technical regulation prescribes specific safety requirements. For those products, the general requirements of Chapters II and III of the Code apply, and those general requirements include product information and consumer information obligations. Language accessibility is therefore a statutory duty, not an administrative preference, and it drives all four localisation steps.

The good news is that the standards themselves do not need to change. Article 2(1)(d) of the Code establishes a preference for international and European standards, so references to ISO, IEC and EN standards in the technical file are encouraged practice. What has to change is not the standards but the wording, the language and the presentation of the documentation.

Each of the four steps has a distinct driver. The language and notarisation step follows from the translation requirements applied to key documents under Article 4 of Government Decree No. 386 of 3 October 2023. The intended use step follows from the fact that clinical practice, patient populations and healthcare settings in Georgia may differ from those assumed in EU documentation. The standards step follows from Article 2(1)(f), which routes conformity assessment through international and European systems, so every citation must remain retrievable for the reviewer. The labelling step follows from the consumer information duties of Chapters II and III of the Code, applied through Article 3(2). Treating the four steps as a checklist rather than as one vague exercise of adaptation is what makes the localisation work auditable.

The practical estimate used by GRZAN when planning such conversions is simple: because the standards need no replacement, the critical path of localisation runs through translation and notarisation rather than through testing. Translators and notaries, not laboratories, determine the timeline, and both resources should be booked as early as the dossier plan is fixed.

2. Legal basis

1. Product Safety and Free Movement Code of Georgia, Law No. 6157-Iს of 8 May 2012: Article 3(2) (where no dedicated technical regulation exists, the general requirements of Chapters II and III apply).
2. Article 2(1)(d): priority application of international and European standards in the field of standardisation; Article 2(1)(f): conformity assessment carried out under international and European systems.
3. Article 2(3): products manufactured in conformity with the EU New Approach and Global Approach directives are deemed to satisfy the essential safety requirements.
4. Health Care Law of Georgia, Law No. 6000 of 21 March 2008, Article 67(1): the ministry develops and implements quality and safety standards.
5. Government Decree No. 386 of 3 October 2023 of Georgia, Article 4: documents must be accompanied by notarised Georgian translations.

3. Expert insights

Insight one: Article 3(2) is the statutory source of the localisation duty.

Dedicated technical regulations for medical devices in Georgia are still under development, and many products currently sit in the zone where no technical regulation prescribes specific safety requirements. In that zone, the general requirements of Chapters II and III of the Code apply. Those general requirements cover product information and consumer information, which means the language of that information matters. This converts translation from a marketing consideration into a compliance obligation with a clear statutory basis.

In practical terms, the duty covers the information a user or patient needs in order to use the device safely: intended use, contraindications, warnings, cleaning and maintenance instructions, and the identification of the manufacturer. A technical file that keeps all of this in English only places the burden of comprehension on the reviewer, the inspector and ultimately the user, and none of these audiences is obliged to carry it.

Insight two: Article 2(1)(d) makes international standard citations a safe choice.

The provision establishes the principle of priority application of international and European standards. Citing ISO, IEC and EN standards in the technical file is therefore encouraged, and there is no requirement to substitute Georgian national standards for them. This substantially reduces the workload of localisation: what must be adapted is the wording and the language, not the underlying standards. Companies should resist any instinct to rewrite standard references during localisation, because doing so can introduce inconsistencies with test reports.

Insight three: Article 67(1) signals that local standards may be layered on top.

The ministry is empowered to develop and implement quality and safety standards for medical technical devices. Although the currently published dedicated standards are limited and not easily retrievable, manufacturers should reserve a section on conformity with local standards when restructuring the technical file. Once such a standard is published, the reserved section can be completed quickly, and the file will not need a full structural rework.

4. Practical recommendations

1. Localisation step 1: prepare notarised Georgian translations of the key pages, meaning intended use, warnings and instructions for use, and provide English versions with translated summaries for the remaining content.
2. Localisation step 2: re-verify the intended use statements against local clinical practice, and remove indications worded only for other specific markets.
3. Localisation step 3: keep the ISO, IEC and EN numbers of cited standards unchanged, and list the acquisition channels for each standard in an annex.
4. Localisation step 4: prepare complete Georgian versions of the label and the instructions for use; an English version may run in parallel but does not replace the Georgian text.

5. Verification checklist

• □ Notarised Georgian translations of the key pages have been completed
• □ Intended use statements have been re-verified against local clinical practice
• □ Standard citations retain their international numbers and are accompanied by acquisition channels
• □ Georgian labelling and instructions for use have been completed
• □ A reserved section on conformity with local standards is in place

Regulatory information verified as of October 30, 2026.

GRZAN supports manufacturers and authorised representatives preparing registration dossiers and conformity documentation for the Georgian market, from EU technical file localisation and language strategy to standard citation mapping and Georgian labelling. For tailored assistance with your Georgia medical device documentation, contact us at info@grzanglobal.com.