Hi Aleksandra,
1. Short answer: it depends.
Longer answer: it depends on the risk class and general safety and performance of the device, and how it interacts with patients/users. For example, an implantable device will most likely require that PMCF studies are conducted, although I can't say for certain what types would be required (I don't have any experience with implantables, so maybe someone else can shine some light on that). Devices intended for high-risk populations, high-risk anatomical locations, or for severe disease/treatment challenges generally require them.
A good way to determine if PMCF studies are needed is by using the
MEDDEV 2.12/2 Section 5 criteria. There's a really great list that can be formulated into a checklist. I'd suggest bringing this into your QMS as a PMCF Determination Form. Decide yes or no for each line, with a justification - this should put you on the right path to determining if they are needed, as well as providing evidence that your decision was formulated based on the guidance and not just a guess.
2. This depends on local regulations, I would think. Where are you marketing the device? How does the device interact with the patient/user? Some countries require that clinical data include persons of that nationality. Others accept foreign clinical trial data. Again, it depends.
3. Yes, there is, but again, this depends on the device in question. Another example: suppose you are a manufacturer of an x-ray tube. This is a higher class device that requires exposing the patient to radiation to get images for diagnosis. You'd think that something so potentially dangerous would require PMCF, right? Looking closer, we see that the tube itself does not interface with the patient, and that the technology is already well-known and established as being safe. From the MEDDEV guidance, "
PMCF studies may not be required when the medium/long-term safety and clinical performance are already known from previous use of the device or where other appropriate post-market surveillance activities would provide sufficient data to address the risks". How long has your device been marketed? Have there been any significant changes to the design that may impact patient safety? Is the technology long-standing and regarded as safe? Depending on your answers to these questions, complaint handling, PSURs, database searches, tracking and trending, etc., may be enough to determine if there are any emergent clinical risks, or a need to update the RBA.
Hope this answers some of your questions! Maybe someone with a little more experience can chime in.