Georgia MDR/IVDR Alignment Status: DCFTA Target 3.1.2 and the Draft Medical Devices Law

1. Key takeaways

Georgia’s MDR/IVDR alignment is still in progress and is not complete. The official basis is the government DCFTA implementation report (second quarter of 2025), target 3.1.2: the output indicator is technical regulations adopted, and the implementation status records that, for the purpose of aligning with (EU) 2017/745 and (EU) 2017/746, the draft Law of Georgia on Medical Devices has been prepared by the Ministry for Occupied Territories, Labor, Health and Social Affairs. The practical consequence for companies is a two-track market: the old, permissive entry regime still operates today, while the future regime is already visible in its draft form. Decisions made now, about technical documentation structure, UDI readiness and post-market surveillance design, determine whether the transition later is a controlled update or an emergency rebuild.

2. Legal basis

1. Government DCFTA implementation report of Georgia (second quarter of 2025, dcfta.gov.ge), target 3.1.2: adoption of technical regulations compliant with (EU) 2017/745 (medical devices) and (EU) 2017/746 (in vitro diagnostic medical devices); verification source is the Georgian legislative bulletin matsne.gov.ge; the responsible body is the Ministry for Occupied Territories, Labor, Health and Social Affairs.
2. European Commission report SWD(2023) 31 Georgia (February 2023): Georgia has adopted legislation aimed at full alignment with the EU acquis, with medical devices listed among the areas covered.
3. Government DCFTA implementation report of Georgia, target 3.1.1: an interagency working group established by ministerial order on April 17, 2025 to develop a strategy for alignment in the fields of standards, conformity assessment, accreditation, metrology and market surveillance.
4. Government Resolution No. 386 of October 3, 2023 of Georgia: the technical regulation on clinical trials of medical devices, already in force.
5. Code of Georgia on Product Safety and Free Movement, Law No. 6157-Iს (May 8, 2012), Article 3¹ (effective June 1, 2026).

3. Expert insights

Insight one: the alignment advances in blocks, not as a single switchover. The clinical trial technical regulation landed in 2023, the market surveillance strategy provision took effect in 2026, and the device statute itself remains at the draft stage. This sequence reveals the legislative strategy: first the technically demanding parts that have international standards to borrow from, then the principal statute that reshapes industry structures. Companies should read the sequence as a forecast: standards conformity requirements will arrive first, and registration system reform will arrive later. Budgeting and staffing plans should mirror that order.

Insight two: the interagency working group under target 3.1.1 is an organizational signal of acceleration. The group established on April 17, 2025 covers five fields: standards, conformity assessment, accreditation, metrology and market surveillance, which are precisely the supporting infrastructure the device statute will need once adopted. Building the infrastructure first means that when the principal law arrives, the execution conditions are largely in place and the transition period may be short. Companies should treat the shortness of the transition as the planning default rather than assuming generous grace periods.

Insight three: the divergence between the EU and Georgian formulations deserves attention. The EU report SWD(2023) 31 states that Georgia has adopted legislation aimed at full alignment with the EU acquis, while the Georgian government’s own account records the draft as prepared. The former evaluates legislative intent; the latter describes legislative progress. Relying on the government’s own account is the safer course, because it explicitly shows that the technical regulations have not yet been adopted, and prudent compliance planning must be built on adopted law, not on aspiration.

Insight four: the verification chain of the report strengthens its evidentiary value. The DCFTA implementation record for target 3.1.2 names dcfta.gov.ge as the publication venue, matsne.gov.ge as the verification source for legislative acts, and the Ministry for Occupied Territories, Labor, Health and Social Affairs as the responsible body. This chain means a company can independently confirm each stage of progress: whether a technical regulation has been adopted is checked against matsne, and the official account of what remains pending is the government report itself. Building this two-source habit, report plus bulletin, into quarterly monitoring turns alignment tracking from rumor management into document management, and it costs almost nothing to operate once set up.

The presence of medical devices in the EU Commission’s assessment also carries a planning implication. SWD(2023) 31 of February 2023 lists medical devices among the areas where Georgia has adopted alignment legislation, which reflects the trial regulation and the sector framework already in place. The gap between that positive framing and the government’s own account of the pending draft statute is not a contradiction but a difference of vantage point: the EU report evaluates trajectory, the government report states status. Both together give the company a more accurate forecast than either alone.

4. Practical recommendations

1. Organize the technical documentation of products entering the market now according to the MDR structure, avoiding a second restructuring once the legislation lands.
2. Complete UDI data fields, post-market surveillance plans and vigilance procedures in advance; these three items are mandatory under the MDR framework.
3. Track the output documents of the interagency working group under target 3.1.1, which will be published ahead of the device statute.
4. Set a trigger mechanism: complete a compliance gap assessment of products on sale within 30 days of the promulgation of the device statute.
5. Record the draft statute’s progress quarterly against matsne publications so that internal plans rest on verifiable milestones.

5. Verification checklist

• □ Technical documentation organized according to the MDR structure
• □ UDI data fields mapped
• □ Post-market surveillance plan and vigilance procedures documented
• □ Outputs of the target 3.1.1 working group listed as tracked items
• □ 30-day gap assessment trigger set for promulgation of the device statute
• □ Quarterly matsne progress log maintained

Regulatory information verified as of October 30, 2026

This English edition is provided by GRZAN, the international regulatory translation service of the GRZAN global compliance desk. GRZAN translates medical device regulatory guidance for manufacturers, importers and authorized representatives preparing documentation for Eurasian, Caucasian and EU-aligned markets. For translation, regulatory monitoring or compliance support inquiries, contact info@grzanglobal.com.