>

Authorisation of clinical trials with medical devices

According to Article 241(5) of the Law on Ethics of Biomedical Research of the Republic of Lithuania (hereinafter – the Law), the scientific assessment of a clinical trial with a medical device and of a clinical trial with an in vitro diagnostic medical device shall be carried out and the authorization to conduct a clinical trial with a medical device or a clinical trial with an in vitro diagnostic medical device shall be issued by the State Health Accreditation Agency under the Ministry of Health (hereinafter – the Accreditation Agency). The authorization shall be issued provided that, according to the assessment of the Accreditation Agency and the conclusion of the ethical review of the Lithuanian Bioethics Committee, the clinical trial with the medical device complies with the requirements of the Regulation on medical devices and the clinical trial with an in vitro medical device complies with the requirements of the Regulation on in vitro diagnostic medical devices, as well as the requirements laid down in the Law.

Where to apply for authorization of a clinical trial with a medical device or a clinical trial with an in vitro diagnostic medical device?

A sponsor wishing to conduct a clinical trial with a medical device or a clinical trial with an in vitro diagnostic medical device in the Republic of Lithuania must submit the required documents to the Accreditation Agency.

What documents must be submitted?

To obtain an authorization of a clinical trial with a medical device or a clinical trial with an in vitro diagnostic medical device, the documents referred to in the Decree of the Minister of Health of the Republic of Lithuania No. V-2745 on the procedure of issuing authorization for clinical trials with medical devices and clinical trials with in vitro medical devices (hereinafter – Procedure of authorization) must be submitted to the Accreditation Agency:

- The list of the required documents for clinical trials with medical devices provided in Annex 1 of the Procedure of authorization;

- The list of the required documents for clinical trials with in vitro diagnostic medical devices provided in Annex 2 of the Procedure of authorization.

All documents must be provided in national language. The list of the required documents is available in Lithuanian, however English-speaking applicants seeking advice are welcome to contact us by email or phone for further assistance.

State fee

state fee of a fixed amount shall be paid for the authorization of a clinical investigation on a medical device or a performance study, or a substantial modification of a clinical investigation on a medical device or a performance study.

Decision on the authorization of a clinical trial with a medical device and clinical trial with an in vitro diagnostic medical device

The approval to conduct trial is issued by the Accreditation Agency upon the positive ethical assessment of the trial of the Group of the Biomedical Research Experts of the Lithuanian Bioethics Committee.

The assessment of clinical trials with medical devices and clinical trials with in vitro diagnostic medical devices shall take no more 45 calendar days (the time given to the sponsor to provide corrected documents due to comments got for the Accreditation Agency is not included).

Procedure for the authorization of a substantial modification of a clinical trial with a medical device or a clinical trial with an in vitro diagnostic medical device

According to Article 241(7) of the Law on Ethics of Biomedical Research, a sponsor wishing to make a substantial modification to a clinical trial with a medical device or a clinical trial with an in vitro diagnostic medical device shall submit to the Accreditation Agency a completed application for a clinical trial with a medical device or a clinical trial with an in vitro diagnostic medical device and the updated documentation referred to in the Procedure of authorization.

According to Article 241(3) and Article 241(7) of the Law, the authorization for a substantial modification of a clinical trial with a medical device or a clinical trial with an in vitro diagnostic medical device shall be issued provided that, according to the assessment of the Accreditation Agency and the conclusion of the ethical review of the Lithuanian Bioethics Committee, the substantial modification of a clinical trial with the medical device complies with the requirements of the Regulation on medical devices and the substantial modification of a clinical trial with an in vitro medical device complies with the requirements of the Regulation on in vitro diagnostic medical devices, as well as the requirements laid down in the Law

Last updated: 16-04-2024