A clinical investigation of a medical device which has not been CE-marked or which is used for a purpose other than the original one within the scope of the clinical investigation may be conducted only if authorised by the Institute.
Before the commencement of the clinical investigation (submission of application for authorisation of the conduct of the clinical investigation), the sponsor of the clinical investigation conducted at a provider’s of healthcare services established within the territory of the Czech Republic shall notify the Institute of its operation as a person handling medical devices (Section 26, paragraph 5 of the Act No 268/2014 Coll., on Medical Devices and on Amendment to Act No 634/2004 Coll., on Administrative Fees, as amended (hereinafter referred to as the “Act on Medical Devices”)).
The application for authorisation of clinical investigation conduct shall be submitted by the sponsor of the clinical investigation electronically, via the Registry of Medical Devices. In addition to the particulars set forth by the Administrative Code, the application shall contain also the clinical investigation dossier:
- Investigator’s Brochure;
- Clinical investigation plan;
- Written approval of the ethics committee;
- Informed consent as referred to by Section 18 of the Act on Medical Devices;
- Document evidencing the conclusion of insurance covering damages, injuries to health or death for the entire course of the clinical investigation;
- A declaration to the effect whether the medical device contains an active substance or a human blood or plasma derivative as its integral part;
- A declaration to the effect whether the medical device has been manufactured using tissues of animal origin with a view to the minimisation of risk of transfer of TSE infection to man;
- A declaration to the effect that the concerned medical device meets the basic requirements governing medical devices in conformity assessment as laid down by other legal regulations governing technical requirements for products, except for aspects which are the subject-matter of clinical investigations, and that with a view to these aspects precautions to protect the health and safety of the user and patient have been adopted.
The Institute shall decide about the application within 60 days of the date of its submission. Where the Institute does not issue a decision within this timeline, it shall be understood that it has authorised the conduct of the clinical investigation.
The Institute recommends that particularly the clinical investigation plan, the investigator’s brochure and the informed consent complied with the requirements set forth by harmonised standard ČSN EN ISO 14155:2012 Clinical investigation of medical devices for human subjects – Good clinical practice
Transitional provision set forth by Section 97, paragraph 1, of Act on Medical Devices:
A clinical investigation of a medical device initiated prior to the date of the coming into force of the Act on Medical Devices and not completed until this date shall be completed and the rights and obligations associated therewith shall be assessed pursuant to current legal regulations (Act No123/2000 Coll., on Medical Devices and on Amendments to Some Related Acts).
Clinical Evaluation of Medical Devices Department