Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear RA colleagues,

We are a company that have been selling custom made implants for several years under MDD and are now MDR certified. In the transition to MDR we reveiwed the MDCG 2021-3 and concluded that our devices can be considered custom made. Our notified body has not questioned this position and review of Technical documentation for these devices has been part of their audits.
However, there are other manufacturers with similar devices that have CE-marked their device. Reading MDCG 2021-3 it is possible to make a case that our also device should be CE-marked. We now see a risk that our notified body changes their opinion and will require us to file for a CE-mark.

My questions:
I wonder if anyone has experience with the transition from custom made to CE-mark?
If our notified body considers that our device should be CE-marked will this automatically take our custom made devices off the market or do you think it is arguable that there should be a transition period?

Thank you in advance!

Good day Anon,

There is often a discussion around whether a custom device is a patient-specific device and vice versa.  Without knowing or understanding the specific device it would be hard to comment if an actual custom device.  However, have seen instances where patient-specific devices presumed to be custom where "transitioned" to normal/regular medical devices.  Under the EU MDD this was a bit more liberal, but under EU MDR more strict on the application of custom devices.  The main point of a custom device is you can not apply a CE Mark.  So companies selling "custom devices" from a marketing point of view realise this may not be the best approach.  To answer the last question, not sure as this may depend on the Notified Body and the relationship with your reviewer.  You would probably need to show the device's safety and performance from current technical information and post market is supporting the device can remain on the market.  Most likely you would need some negotiating with your Notified Body, but could not say.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 23-Feb-2022 18:09
From: Anonymous Member
Subject: Transition of Custom Made to CE

This message was posted by a user wishing to remain anonymous

Dear RA colleagues,

We are a company that have been selling custom made implants for several years under MDD and are now MDR certified. In the transition to MDR we reveiwed the MDCG 2021-3 and concluded that our devices can be considered custom made. Our notified body has not questioned this position and review of Technical documentation for these devices has been part of their audits.
However, there are other manufacturers with similar devices that have CE-marked their device. Reading MDCG 2021-3 it is possible to make a case that our also device should be CE-marked. We now see a risk that our notified body changes their opinion and will require us to file for a CE-mark.

My questions:
I wonder if anyone has experience with the transition from custom made to CE-mark?
If our notified body considers that our device should be CE-marked will this automatically take our custom made devices off the market or do you think it is arguable that there should be a transition period?

Thank you in advance!