Georgia Medical Device Law Legislative Pipeline 2026: Draft Status and MDR/IVDR Alignment Outlook

1. Key takeaways

The draft Law on Medical Devices of Georgia has completed drafting, but as of October 30, 2026 its enactment has not been observed. The official basis is the record in the implementation column of target 3.1.2 of the DCFTA implementation report of the Government of Georgia (second quarter of 2025), which states that in order to align with Regulation (EU) 2017/745 and Regulation (EU) 2017/746, the draft Law of Georgia on Medical Devices has been drafted by the Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs. Companies are currently in a window characterised by low-cost entry, with upgrade space to be reserved. Products placed on the market in this window benefit from the light current requirements, but every document produced now will be tested against the future MDR-style framework later, so the economic question is not only what the law requires today, but how cheaply today’s files can be migrated tomorrow. Treating the window as an opportunity to build MDR-shaped documentation at Georgian pace is the strategy that converts the coming legislative change from a compliance shock into a routine transition.

2. Legal basis

1. DCFTA implementation report of the Government of Georgia, second quarter of 2025, publicly released on dcfta.gov.ge, target 3.1.2: the output indicator is technical regulations adopted, the verification source is the Georgian legislative bulletin matsne.gov.ge, and the responsible institution is the Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs.
2. European Commission report SWD(2023) 31 Georgia (February 2023): records that Georgia has adopted legislation in the fields including medical devices aimed at achieving full alignment with the EU acquis.
3. DCFTA implementation report of the Government of Georgia, target 3.1.1, second quarter of 2025: developing an alignment strategy in the fields of standardisation, conformity assessment, accreditation, metrology and market surveillance in line with the requirements of the EU 2024 enlargement report; an interagency working group established by ministerial order on 17 April 2025.
4. Government of Georgia Decree No. 386 of 3 October 2023: technical regulation on clinical investigations of medical devices, the dedicated regulation already in force.
5. Product Safety and Free Movement Code of Georgia, Law No. 6157-Iს (8 May 2012), Article 3¹: added by Law No. 1447 of 1 April 2026, in force from 1 June 2026.

3. Expert insights

Insight 1: the legislative rhythm can be decomposed into three observable nodes. The first node is the drafting of the bill, which is completed. The second node is the adoption of technical regulations by government resolution, which is the output indicator of target 3.1.2. The third node is the adoption of the dedicated law by parliament. Companies can monitor the government resolution section and the law section of matsne.gov.ge separately, and both entry points must be watched. The value of the decomposition lies in attribution: when a node moves, the company knows exactly which stage of its readiness plan must accelerate, instead of reacting to rumour or to generic statements about alignment that carry no procedural information.

Insight 2: clinical investigations are the part that landed first. Decree No. 386 has been in force since 2023, which shows that Georgia pursues a strategy of legislating in blocks, starting with the parts that are technically demanding and supported by international standards, before advancing the comprehensive device law. The strategy signals that subsequent legislation will most likely continue the drafting technique of direct reference to international standards, and the importance of standards such as ISO 14155, ISO 13485 and ISO 14971 will keep rising. Manufacturers that build their quality systems and clinical evidence around these standards are therefore not merely preparing for Georgia; they are pre-adapting to the exact instruments the Georgian legislature has shown it prefers to cite.

Insight 3: the entry into force of Article 3¹ means enforcement tightens before legislation does. The provisions on the national market surveillance strategy entered into force on 1 June 2026 and require the Ministry of Economy and Sustainable Development to prepare the strategy at least every 4 years. The building of enforcement capability will be completed before the dedicated law arrives, and companies cannot use the argument that the law has not yet been enacted to explain post-market non-compliance. In practical terms, market surveillance readiness, including complaint handling, field safety corrective action capability and distribution records, should be treated as already applicable, because the institutional machinery that will enforce the future law is being assembled now. A practical marker to watch is the publication of the first national market surveillance strategy under the new provision. Its priority product lists and inspection criteria will reveal how the enforcement apparatus intends to operate, and they will almost certainly inform the scope of the future device law as well. Reading the strategy when it appears, and mapping its priorities against the company portfolio, is a low-effort action that yields an early view of where the coming regime will bite first.

4. Practical recommendations

1. Establish dual-entry legislative monitoring: the government resolution section of matsne.gov.ge for technical regulations and the law section for the Law on Medical Devices.
2. Organise the technical documentation of products now entering the market according to the MDR structure, reserving interfaces for the later upgrade and avoiding a second reconstruction.
3. Complete the UDI data fields and the post-market surveillance procedures in advance; both are mandatory under the MDR framework, and preparing them now is the lowest-cost moment.
4. Include the legislative monitoring results in the quarterly compliance review and set a trigger condition: complete a compliance gap assessment of all products on sale within 30 days of the enactment of the dedicated law.

5. Verification checklist

• □ Monitoring entry points for both government resolutions and laws configured on matsne.gov.ge
• □ Technical documentation organised according to the MDR structure
• □ UDI data fields mapped
• □ Post-market surveillance procedure documented
• □ Trigger mechanism set for a gap assessment within 30 days of enactment of the dedicated law

GRZAN international services — GRZAN tracks the Georgian legislative pipeline, prepares MDR-structured technical files and supports upgrade planning for the future Law on Medical Devices. For enquiries about this guide, contact info@grzanglobal.com.

Regulatory information verified as of October 30, 2026