The Impact of a No Deal Brexit on Medical Devices
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Medical Device manufacturers need to be aware that in the event of a no deal Brexit certificates from Notified Bodies registered in the UK will no longer be valid for CE marking of devices. Certificates will only be valid if issued by a Notified Body registered in the EC. If no valid certificate is in place shipment of devices to the EC will no longer be possible.
The Medical Device Committee advises that manufacturers with EC registered products talk to their Notified Body urgently to review the options which may be available to them.