| (1) | A person desiring to initiate or conduct— |
| (a) | a clinical trial or clinical investigation in respect of an unregistered medical device; |
| (b) | a clinical performance assessment for an IVD; or |
| (c) | a new intended purpose of a registered medical device or IVD, |
must apply to the Council on a form, determined by the Council, for authorisation to conduct the clinical trial, clinical investigation or clinical performance assessment.
| (2) | The application referred to in subregulation (1) must be accompanied by the prescribed fee and must contain at least the following information: |
| (a) | A clinical investigation plan or clinical trial or clinical performance assessment for an IVD protocol; |
| (b) | an investigator's brochure containing, where applicable, relevant pre-clinical, mechanical, electrical and radiation data and where applicable, human or animal clinical data with the medical device or IVD concerned; |
| (c) | the Curriculum Vitae of the investigator; |
| (d) | a signed declaration by the applicant and the investigator that they are familiar with, and understand the protocol, and will, in the conduct of the clinical investigation or clinical trial, comply with Good Clinical Practice as determined by the Council; |
| (e) | informed consent documents and endorsements by an ethics committee recognised by the Council; and |
| (f) | the name and address of the institution where the clinical trial or clinical investigation will be conducted. |
| (3) | The clinical investigation plan, clinical trial or clinical performance assessment for an IVD protocol referred to in subregulation (2)(a) must contain at least the following information: |
| (a) | The number of human or animal subjects, as applicable, to be involved in the clinical investigation, clinical trial or clinical performance assessment for an IVD; |
| (b) | the name of the investigator who must be— |
| (i) | an appropriately qualified and competent person approved by the Council; |
| (ii) | resident in the Republic; and |
| (ii) | in charge of the sites where clinical trials or clinical performance assessment for an IVD are conducted; |
| (c) | the quantity of the investigational medical device or IVD units to be used in the clinical trial, clinical investigation or clinical performance assessment for an IVD; |
| (d) | information in respect of the design, manufacture and expected performance of the medical device or IVD; and |
| (e) | any other information determined by the Council. |
| (4) | A clinical investigation and a clinical trial or a clinical performance assessment for an IVD must be conducted in accordance with the guidelines for good clinical practice determined by the Council. |
| (5) | A person may not conduct a clinical investigation, a clinical trial or a clinical performance assessment for an IVD referred to in subregulation (1), without the authorisation of the Council (6) The person conducting the clinical investigation, clinical trial or clinical performance assessment for an IVD must submit to the Council— |
| (a) | progress reports after every six months from the date when the clinical investigation, clinical trial or clinical performance assessment for an IVD was started, and 30 days after the completion or termination of the clinical investigation, clinical trial or clinical performance assessment for an IVD; and |
| (b) | adverse event reports immediately or as soon as practically possible. |
| (a) | request additional information; |
| (b) | inspect a clinical investigation, clinical trial or clinical performance assessment for an IVD; or |
| (c) | withdraw the authorisation to conduct a clinical investigation, clinical trial or clinical performance assessment for an IVD, if the Council is of the opinion— |
| (i) | that the safety of the subjects of the clinical investigation, clinical trial or clinical performance assessment for an IVD is compromised; or |
| (ii) | that the scientific reasons for conducting the clinical investigation, clinical trial or clinical performance assessment for an IVD, have changed. |
(8)
| (a) | The following information for a medical device or IVD referred to in subregulation (1) must be provided, where applicable: |
| (i) | The intended purpose or use of the investigational medical device irí the proposed clinical investigation or clinical trial; |
| (ii) | the populations and indications for which the investigational medical device is intended; |
| (iii) | the name or number of the model or type, including software version and accessories, if any, to permit full identification; |
| (iv) | a description as to how traceability is to be achieved during and after the clinical investigation, (e.g. by assignment of lot numbers, batch numbers or serial numbers); |
| (b) | The medical device or IVD must— |
| (i) | where practical, be labelled with the name and address of the premises where the clinical investigation, clinical trial or clinical performance assessment for an IVD is to be carried out; and |
| (ii) | be labelled for investigational use only. |
| (9) | The Council may, subject to such conditions as may be determined by the Council, authorise the conduct of a clinical investigation, clinical trial or clinical performance assessment for an IVD. |
