Anon,
As mentioned, most Notified Bodies will not provide any comments or feedback on clinical investigation plans; they may comment on strategy. Strategy is high level and clinical plans are more detailed. If queried they usually point the Manufacturer to sections of the Regulation or guidance documents. Getting any more specific information such as acceptance of foreign country data ... well good luck. Therefore, it is helpful to get external support in this case with organisation/individuals familiar with the regulation and expectations for clinical investigation/study conduct. The use of foreign data, in your case using US patient population for CE marking, could be acceptable depending on type of device, disease condition, proliferation of disease in the population, ethnic differences, practice of care differences, etc. etc. These can be addressed as part of clinical planning, but there are many factors to consider. The level of detail here you are most likely not going to get any specific feedback from a Notified Body.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 11-Apr-2024 02:31
From: Bianca Lutters
Subject: Consultation with a EU notified body on clinical investigation plan
Requesting feedback from notified bodies on a clinical investigation plan may be seen as consultancy, so many notified bodies will only be open to providing limited feedback, if any.
Qserve has experience with numerous clinical data collection efforts for low risk devices that have been used to support CE-marking under the EU MDR. This can be clinical investigations, but also simpler ways to collect clinical data as the EU MDR does not require clinical investigations for class I and class IIa devices. It requires sufficient clinical data.
The most important question on what is required for your device is "what is sufficient clinical data" for your device? This depends on aspects such as the classification of the device, the type of device and the novelty of the device.
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Bianca Lutters PhD
Qserve Group (Netherlands)
Arnhem
Netherlands
Original Message:
Sent: 09-Apr-2024 23:00
From: Anonymous Member
Subject: Consultation with a EU notified body on clinical investigation plan
This message was posted by a user wishing to remain anonymous
I work for a company that manufactures Class I and Class IIa products. We are planning a clinical investigation in the US which will be used for CE-marking.
Does anyone have recent experience with requesting feedback from a notified body on a proposed clinical investigation plan for a new product?