I've poked around on Google quite a bit trying to find an answer, but have failed miserably to find an answer. I'm trying to wrap my mind around the MDR as a whole, and this has me tripped up.
According to Article 2 (3) "mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices; "
I work with predominately Class IIb sterile, single-use (disposable) devices. We have several clinicians who request "custom devices" because they want to do XYZ procedure a different way/ from a different angle/ etc... often the requests are something to the tune of "slightly smaller", "slightly longer/ shorter", "bent this way, not that way", "Rounded, not sharp", "Sharp, not rounded"... You get the idea. I've worked with custom products before, with a different company, and I know now, that they were not really handled in a compliant way. That company eventually stopped making custom products because compliance was deemed "too difficult"- I understand that is a common theme in the industry. The custom devices that were created with my previous company, and now in my current company, often fed into (even becoming) the R&D process for a future product. Logically, I don't see a problem with this- it almost feels like iterations of design validation (albeit with very limited clinician feedback). But from a regulatory perspective, this seems like a no-no.
If adapted versions of a mass-produced device is requested by a physician to meet his/her specific requirements is not a custom-made device, then how is that sort of device regulated?
My organization works closely with clinicians, and prides itself on that. If we are to continue making devices according to clinician requests, I want us to handle these situations in a complaint manner. I'm aware I will be upsetting the apple cart as it is, I just want to know how much.
According to Article 2 (3) "mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices; "
I work with predominately Class IIb sterile, single-use (disposable) devices. We have several clinicians who request "custom devices" because they want to do XYZ procedure a different way/ from a different angle/ etc... often the requests are something to the tune of "slightly smaller", "slightly longer/ shorter", "bent this way, not that way", "Rounded, not sharp", "Sharp, not rounded"... You get the idea. I've worked with custom products before, with a different company, and I know now, that they were not really handled in a compliant way. That company eventually stopped making custom products because compliance was deemed "too difficult"- I understand that is a common theme in the industry. The custom devices that were created with my previous company, and now in my current company, often fed into (even becoming) the R&D process for a future product. Logically, I don't see a problem with this- it almost feels like iterations of design validation (albeit with very limited clinician feedback). But from a regulatory perspective, this seems like a no-no.
If adapted versions of a mass-produced device is requested by a physician to meet his/her specific requirements is not a custom-made device, then how is that sort of device regulated?
My organization works closely with clinicians, and prides itself on that. If we are to continue making devices according to clinician requests, I want us to handle these situations in a complaint manner. I'm aware I will be upsetting the apple cart as it is, I just want to know how much.
