A
Anon7111
Hello Everyone,
Need some help designing a post-market clinical study (PMCF) to satisfy one of the EU notified bodies. The device is a Class III orthopedic revision implant. The problem is that during a revision surgery, the surgeon may not use components from one manufacturer. However, while mixing and matching implant components from different manufacturers is warned against in most IFUs, it is common practice during revision surgeries. Is anyone aware of a study design that takes this into consideration? If the inclusion criteria includes the requirement that all components implanted or present in the patient is ours (one company's components), we will not get any subjects enrolled. A prospective study design is therefore not feasible and the notified body is not accepting a retrospective study design for newly approved EU Class III revision devices.
Any guidance is much appreciated.
Need some help designing a post-market clinical study (PMCF) to satisfy one of the EU notified bodies. The device is a Class III orthopedic revision implant. The problem is that during a revision surgery, the surgeon may not use components from one manufacturer. However, while mixing and matching implant components from different manufacturers is warned against in most IFUs, it is common practice during revision surgeries. Is anyone aware of a study design that takes this into consideration? If the inclusion criteria includes the requirement that all components implanted or present in the patient is ours (one company's components), we will not get any subjects enrolled. A prospective study design is therefore not feasible and the notified body is not accepting a retrospective study design for newly approved EU Class III revision devices.
Any guidance is much appreciated.
