Georgia Medical Device Clinical Evaluation: Citing CE Evidence and Decree No. 386 of 2023

1. Key takeaways

For CE clinical evaluation reports, the scientific conclusions can be cited directly, but the text of the report cannot be filed as a whole. The written basis in Georgia is Government Decree No. 386 of 3 October 2023, Article 4. The decree requires that clinical trial protocols and informed consent documents carry notarised Georgian translations, and it invokes the Declaration of Helsinki, ICH GCP and ISO 14155:2020. Whether local clinical data are needed depends on whether the product requires a clinical study to be conducted in Georgia.

The decree is titled as the technical regulation on the conduct of clinical trials of medical devices. This title is the key to its scope: it regulates studies performed inside Georgia, not the clinical evidence required for registration. The distinction saves manufacturers from a common and costly misunderstanding, because registration evidence can be satisfied by citing foreign data, and the full procedure of the decree is triggered only when a study is actually run in Georgia.

What must be redone is a set of three localisation items: the Georgian translation, the local versions of subject information and informed consent if a Georgian trial is run, and a population applicability statement explaining whether differences between the reference population and the Georgian population affect the conclusions. None of the three can be avoided by direct filing, while the underlying science of a compliant CE clinical evaluation can be carried over intact.

For manufacturers starting from a CE dossier, the sequence is fixed. Take the scientific conclusions of the clinical evaluation report, attach the data index that points to each underlying study, annex the source documents, and add a Georgian summary. Only then ask whether any element of the file depends on a study that would have to be run in Georgia, which is the question that determines whether the procedure of Government Decree No. 386 of 3 October 2023 ever begins. In most cases it does not, and the entire effort reduces to translation, indexing and the population applicability statement.

2. Legal basis

1. Government Decree No. 386 of 3 October 2023 of Georgia, the technical regulation on the conduct of clinical trials of medical devices: it invokes the Declaration of Helsinki, ICH GCP and ISO 14155:2020.
2. Article 4 of the decree: conditions for conducting clinical trials include the registration certificate issued by the institution, affirmative opinions of the local ethics committees of each participating institution, a legally registered representative in Georgia, and the protection of the rights of vulnerable groups.
3. The same article lists the required documents: the application and the registration fee payment receipt; the sponsor’s power of attorney (original, or apostilled or consularly certified and notarised); the clinical trial protocol and the trial plan conforming to GCP with notarised Georgian translations; preclinical trial materials; the subject information sheet and a written informed consent template with notarised Georgian translations; the case report form (CRF); a copy of the documents confirming that trial risks and liabilities are covered; documents proving the device is manufactured according to relevant standards; the written consent of the heads of the participating medical institutions and of the clinical leads; and well-substantiated affirmative opinions of the local independent ethics committees of each participating institution.
4. Product Safety and Free Movement Code of Georgia, Law No. 6157-Iს of 8 May 2012: Article 2(1)(d) and Article 2(3).
5. Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of 10 August 2009, Article 11¹¹: scientific-technical review.

3. Expert insights

Insight one: the reference to ISO 14155:2020 in Government Decree No. 386 of 3 October 2023 amounts to recognition of the international clinical evidence standard.

The citation means that clinical data generated under ISO 14155 are acceptable in Georgia. Where a CE clinical evaluation report rests on studies conforming to GCP and ISO 14155, its scientific conclusions can be cited directly, and the full clinical evaluation does not have to be rebuilt for Georgia. The recognition also narrows the argument space for reviewers to reject foreign evidence on methodological grounds, provided the data are properly indexed and traceable.

Insight two: what must be redone is the localisation set of three items.

First, the Georgian translation, which the decree requires at notarisation level. Second, the local versions of subject information and informed consent documents, relevant when a trial is run in Georgia. Third, the population applicability statement, explaining whether differences between the reference population and the Georgian population affect the conclusions. These three items cannot be avoided by any direct filing strategy; everything else in a compliant CE clinical evaluation can be carried over.

Insight three: the decree regulates clinical research conducted in Georgia, not a local clinical requirement for registration.

The two must not be confused. Clinical evidence for registration can be satisfied by citing foreign data. Only when a clinical study is conducted on Georgian territory is the full procedure of Government Decree No. 386 of 3 October 2023 triggered. Making this distinction at project start prevents companies from launching unnecessary local studies and from budgeting for ethics committee timelines that were never required.

4. Practical recommendations

1. Decide first whether a clinical study in Georgia is actually needed; if not, do not start the procedure of Government Decree No. 386 of 3 October 2023.
2. When citing a CE clinical evaluation report, use the structure of conclusions plus data index plus source annexes, and attach a Georgian summary.
3. Supplement a population applicability statement, setting out the differences between the reference population and the local population and the justification for extrapolating the conclusions.
4. If a trial in Georgia is required, prepare item by item against the checklist of Article 4, with particular attention to the early arrangement of ethics committee opinions and the legally registered representative.

5. Verification checklist

• □ It has been determined whether the procedure of Government Decree No. 386 of 3 October 2023 needs to be started
• □ The CE clinical evaluation report is cited in a conclusions plus index plus annexes structure
• □ A Georgian summary has been prepared
• □ The population applicability statement has been written
• □ If a trial in Georgia is needed, the checklist of Article 4 has been implemented item by item

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 CE clinical evaluation citation strategy and population applicability statements to trial planning under Government Decree No. 386. For tailored assistance with your Georgia medical device documentation, contact us at info@grzanglobal.com.