Finland - Clinical Investigations on Medical Devices
Investigation plans concerning clinical investigations and their amendments must be submitted for evaluation by an ethics committee beforehand, regardless of whether the National Agency for Medicines must be notified of the investigation or not.
The investigator in charge of the investigation is responsible for submitting the investigation plan for the approval of an ethics committee. The investigation plan must be clearly and individually identifiable.
2.3 Competence of the investigator in charge of the investigation
Clinical investigations on medical devices require that the investigator is as well-experienced as possible regarding the characteristics, performance and adverse effects of the medical device being investigated.
The investigator in charge of a clinical investigation must be a doctor or a dentist, The investigator in charge of the investigation must have adequate experience with clinical investigations on medical devices and preferably a qualified specialist in the clinical specialty to which the investigation belongs.
If a group of investigators is responsible for conducting the investigation, the group may include a hospital engineer, hospital physicist or a hospital chemist in addition to the doctor or dentist.
2.4 Investigation site
The site where the clinical investigation is to be performed shall be suitable for the purpose of the investigation and have well-established operations in the area pertaining to the clinical investigation. Clinical investigations shall be performed under conditions that correspond to those under which the device is normally used and that are suitable for the appropriate, safe and competent performance of the investigation.
The first clinical investigations on Class III devices and on implantable devices and large-scale clinical investigations as well should generally be conducted at clinics or clinical departments of well equipped university hospitals or healthcare units of comparable standard, or else under their supervision. The health care unit directing or coordinating the clinical investigation can ensure that expertise in the field of research is adequately taken into account when the investigation is performed.
When the purpose of a clinical investigation on medical devices is to investigate the effects of a new device in a situation comparable to the outpatient use of the medical device, the investigation must be performed in a healthcare centre or in a private outpatient care unit.