- European MDR requirements will affect criteria for medical device clinical study investigators and sites;
- Fewer clinicians will qualify as pre-clinical study investigators under the MDR;
- PMCF study sponsors and investigators should not underestimate requirements and obligations;
- In-person facility inspections and personnel interviews should be conducted to mitigate risks and determine proper clinical study support.
With the requirement in the new European Medical Devices Regulation (MDR) to provide an increased amount of clinical evidence, more and more surgeons and physicians will need to be involved, not only in studies conducted to obtain the CE Mark (pre-CE clinical studies), but also in studies conducted after marketing of the medical device (post-market clinical follow up or PMCF studies). This is expected to lead, especially in some “popular” indications, to a shortage of surgeons and physicians willing or able to participate in clinical studies.
Pre-CE clinical studies
For pre-CE clinical studies, very stringent requirements apply to the investigators and involved study personnel qualifications, such as certified Good Clinical Practice (GCP) training or documented experience in conducting clinical trials, as well as to the composition of the study team and for the facility and facility equipment. Please note that these requirements can vary to some extent from country to country.
Due to these strict standards the number of investigators who qualify to conduct pre-CE clinical studies is limited. For example, obtaining required GCP training is often a hurdle for otherwise qualified investigators, as it is often difficult to incorporate these trainings into their busy clinical daily routines.
For PMCF studies the requirements are less stringent, and generally any surgeon or physician with experience in the field of investigation can become an study investigator. However, whenever possible it is advisable to exclusively include investigators, who are experienced in conducting clinical studies and ideally also trained in GCP (required in many countries).
Unfortunately, when selecting investigators for PMCF studies the duties and tasks related to the conduct of the study are often underestimated by both the sponsor (device manufacturer) and also the involved investigator. This introduces the risk that the investigator may not be able to include the expected number of patients, or that the quality of the data to be collected suffers…