On discontinuation of a medical device, it is compulsory for the manufacturer to continue to provide parts and components for the discontinued device. The period that the manufacturer must continue to provide the parts and components is equal to the lifetime of the device.
The devices sold last need to be covered for their lifetime regardless the discontinuation.
The (expected) lifetime of the device is defined in the technical documentation.
- Correct me if I am wrong/not complete.
- Is there in any other part of MDR (except for GSPR .6? combined with the definition in the device’s technical
documentation) where this obligation is laid down?
Thanks in advance for your advice