Testing Standards - Regulatory agency doing Enforcement Testing of Medical Devices

[pseudoazurin]

Hi guys, would anyone knows, when the regulatory agency doing enforcement testing of medical devices, how do they do the test, as after all, in EU, with CE mark, it doesn't mean that they are comply with the exactly same testing standard with same accuracy requirement, so how inaccurate that the product will deem to be of "hazard" to use.

Thx.

[PaulGr]

I am not sure if I understand your question.

Are you asking about re-testing by authorities for a device that's already approved for CE based on your own testing? From my experience with Chinese authorities doing testing, it helps when you supply your original test plan and report to explain your methods. Or better, arrange for a situation where you can do the testing and have the authorities witness the test...

If I misunderstood your question, could you please explain a little further?

[pseudoazurin]

no, I mean as testing as an enforcement act at the border. After all we got the best product tested for CE application, then what we sent off to the market could be different, as shown in the EU implant case. The custom or the test lab, I presume, won't have the product technical file, so they won't be able to repeat your test method and acceptance criteria, and they have to test the product based on their own way, so what is the accepted "own way"?

[Ronen E]

In Reply to Parent Post by pseudoazurin

no, I mean as testing as an enforcement act at the border. After all we got the best product tested for CE application, then what we sent off to the market could be different, as shown in the EU implant case. The custom or the test lab, I presume, won't have the product technical file, so they won't be able to repeat your test method and acceptance criteria, and they have to test the product based on their own way, so what is the accepted "own way"?

Relating to the EC (if you meant another territory please specify it) -

If you referred to the PIP breast implants, this case just demonstrated that the system doesn't deal too well with fraud. I don't think there'd be any systematic sampling and/or testing to enforce CE marking compliance at the border control level. That's the CE mark's concept - compliance is substantiated once, then monitored periodically, and the mark itself provides presumption of conformity at the market's entrance. Further probing by the NB/authorities is/should be based on the vigilance system's indications that something has gone wrong, or other grounds (why wasn't that the case with PIP - perhaps the courts will say in due course).

If you only referred to natural variation in device quality (across different units / lots), and not to a fraudulent act, then the devices you have tested to demonstrate compliance in the first place should have been a representative sample of the quality that could be expected in commercial production. If you only tested "best" devices then your validation practices were lacking, and your NB's auditing should have spotted that. If that wasn't the case, but you realized over time (post distribution commencement) that the general or average device quality is lower than expected/substantiated during initial clearance (or has actually deteriorated), then in my opinion you should repeat the initial testing - utilizing a current representative sample of devices - and communicate your findings to your NB (if you have one). Otherwise, in my opinion you might be in breach of the MDD.

Cheers,
Ronen.

[pseudoazurin]

Thanks for the essay, but is missing the point and not answering the question that how do the custom or regulatory authority test the medical device that they sample on the border (or in the market), or may be they just never test products.

[Ronen E]

In Reply to Parent Post by pseudoazurin

Thanks for the essay, but is missing the point and not answering the question that how do the custom or regulatory authority test the medical device that they sample on the border (or in the market), or may be they just never test products.

"Never" is a very strong word, but the reality may not be very far from that (at least as far as I know).