State Institute for Drug Control

The sponsor shall safeguard the commencement, management, organisation, control, or, where applicable, the financing of the clinical investigation at a provider’s of healthcare services.

The sponsor shall be obliged to commence and conduct the clinical investigation in compliance with Section 14 of the Act on Medical Devices; the sponsor’s obligations are laid down in Section 19 of the aforementioned Act.

Prior to the commencement of the clinical investigation the sponsor shall be obliged to:

• Notify in advance and in writing the concerned ethics committee of his intention to conduct the clinical investigation; where multicentric clinical investigation is concerned, the sponsor shall notify all ethics committees established by the providers where the clinical investigation is to be conducted of his intention to conduct the clinical investigation;

• Forthwith inform the Institute and the concerned ethics committee of the commencement of the clinical investigation;

• Safeguard the preparation of the clinical investigation dossier;

• Appoint the investigator of adequate expert and specialised qualification, expertise and knowledge of the use of the investigational medical device who will be authorised to conduct the respective expert activities and knowledgeable of the clinical environment where the clinical investigation is to be conducted;

• Safeguard for the investigator the investigator’s brochure, instructions, IFUs, technical data about the investigational medical device, including the results of risk analysis, information obtained from preclinical testing relevant to the subject-matter of the clinical investigation, declaration of the manufacturer or authorised representative that the medical device complies with the basic requirements governing medical devices in conformity assessment except for aspects which are the subject-matter of the clinical investigation, and that with a view to these aspects, any precautions to protect the health and safety of trial subjects have been adopted. Furthermore, information on whether the medical device contains an active substance or human blood or plasma derivatives or whether it has been manufactured using non-live tissues or cells of human or animal original or derivatives thereof, and, if applicable, other information necessary for the conduct of the clinical investigation;

• Conclude written agreements referred to by Section 14 paragraph 2(k) of the Act on Medical Devices;

• Contract insurance covering damages, injuries to health or death for the duration of the conduct of the clinical investigation;

• Approve and endorse with a signature the clinical investigation plan;

• Hand over the medical device intended for clinical investigations and mentioned by the clinical investigation plan to the investigator;

• Submit to the Institute the Application for authorisation of clinical investigation conduct, where a medical device which has not been CE-marked or which is to be used for a purpose other than the original one within the scope of the clinical investigation is concerned; where changes to the clinical investigation in its course are concerned, the obligation to submit the application for authorisation of such changes to the Institute shall apply accordingly.
     

In the course of the clinical investigation the sponsor shall be, moreover, obliged to: 

• Following agreement with the investigator, safeguard the collection and evaluation of statistical data, selection of trial subjects, and methods and procedures for recording and analysis of all Adverse Events and Serious Adverse Events arising from the medical device testing;

• Review and, in case of acceptance, approve any deviation from and change to the clinical investigation plan and submit the proposed changes to the clinical investigation dossier to the ethics committee for approval thereby;

• In the course of the clinical investigation provide the Institute and the concerned ethics committee with the annual progress report and evaluation of the safety of the clinical investigation, no later than by 31 January of the following year;

• Assess, together with the investigator, any Serious Adverse Events arising from the testing of the medical device and inform other investigators, the Institute and the ethics committee thereof forthwith as they arise; the particulars of the Serious Adverse Event report to the Institute are set forth by Section 2 of Decree No 62/2015 Coll., implementing some provisions of the Act on Medical Devices;

• Inform the Institute and the concerned ethics committee about the suspension or termination of a clinical investigation no later than within 30 days, including a rationale where early termination is concerned.   

Upon completion of the clinical investigation, the sponsor shall be obliged to:

• Approve and endorse with his signature the final report from the clinical investigation and submit the report to the Institute and to the concerned ethics committee;

• Keep records on all Adverse Events and Serious Adverse Events arising during the testing of the medical device which have been notified thereto in the course of the clinical investigation for the period of at least 5 years and, where implantable medical devices are concerned, for the period of at least 15 years of the date of manufacture of the last product.

Clinical Evaluation of Medical Devices Department

1.7.2015