How long to wait for Notified Body Response - Potentially significant change to a medical device

[robert.beck]

Here is the situation: the notified body has been appropriately informed of a potentially significant change to a device, and has responded that because of their workload they cannot give even an estimate of when they will review the notification. we would prefer that they review and approve the change, but because of the switch of emphasis from MDD to MDR, the notified body is overwhelmed. This puts the company into a grey area. any recommendations for actions we can take? how long is a reasonable period to wait for a notified body response before going ahead with business plans that involve the device change?

 

[craiglab]

If you haven't already, I would recommend discussing with your scheme manager via the phone. If that person is also a technical specialist (typically) then you may have an opportunity to explain why the change is NOT significant and guide that person a bit down the path.

 

[robert.beck]

Thank you for your comment. I did not write the question clearly enough. We have tried to get the scheme manager to write a letter of tentative approval. He has indicated that "This is not forgotten you are in the work queue ... . will keep you appraised as we move forward as soon as possible." This response was two weeks after the documentation had been submitted for review and approval. we had wanted a target date, but got answer that is too vague.

Our question is, failing any response from the NB, what are our options? Waiting indefinitely is destructive to the business and is not acceptable. Like many companies, Quality and Regulatory are not in the driver's seat. The actual change is simple - we changed authorized representatives (AR) and need an updated CE certificate in order to register the device. The new AR refuses to do the registration until the certificate is updated. In the meantime, devices are being shipped for use in a clinical trial. Timelines are at risk. We expect to face a very similar situation with an upcoming product change. In this future case, delays will cost the company dearly, and may adversely affect the business side.

 

[craiglab]

Is a new EC certificate being requested because the old AR is shown on it somewhere, such as in a list of significant suppliers?

 

[robert.beck]

yes, that's it exactly. we need to register the device in Spain, and the new AR won't do that until we get a new EC certificate, and we can't get a new EC certificate until the NB approves the AR change.

are you suggesting that we can modify the certificate by removing the AR?

 

[craiglab]

I would never suggest modifying the actual certificate! But I am aware that some NBs show the certificate on page 1 of 1 and then attach a list of significant suppliers, which could be 20 pages long. In my opinion, that list is confidential and I do not share it with anyone except on request, and it has never been requested. And I would probably only share it with the AR and a CA if requested. Other NBs I've used do not include such a list. It is not a requirement of the certificate.

 

[robert.beck]

unfortunately, in this case the AR is listed on page 2 of a three-page certificate, again on page 3 which is the revision history of the certificate document.