A: The number of employees doesn’t really matter here. If you’re a small company, but you’ve got a class 3 device that can harm patients, then you still need to comply with all the requirements.
I think the only area where I say small companies get some leeway is the person responsible for regulatory compliance – the PRRC. If you are a small company, you don’t need to have this particular person within your organization. However, you must have access to this particular person on a continuous basis. If you’re working with a consultancy firm, like Celegence, they will be readily available. You don’t need to employ the PRRC as part of your staff in your organization, but if you’ve got a contract with a consultancy like Celegence, they are deemed acceptable.
A: You’ve got software as a medical device, and then you’ve got medical device software, the MDR makes it clear on the classification of softwares if you go to ANNEX 8 – Rule 11.
This rule gives a classification on whether the software is a class 1, class 2, or class 3, and depending on the classification, you go through the reports that are needed for that particular classification. Your software must be classified, and once you classify it, go through articles 83 to 92 to draft the ones that are applicable to that particular class of the device.
A: Yes, PSUR is applicable to legacy devices. From the 26th of May, 2021, all devices on the market need to comply with your PMS requirements. There’s no exception to legacy devices.
In terms of PMS requirements and the reports that are needed for PSUR, legacy devices have no exceptions. You have to go through all the requirements and all the aspects that are needed. Treat your PSUR similar to a PQR, a product quality review, which is going into the pharma world but they should be approached in a similar way.
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