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Availability of parts and components for a discontinued medical device

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Guest user Created:   Feb 09, 2021 Last commented:   Feb 11, 2021

Availability of parts and components for a discontinued medical device

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.

  1. Correct me if I am wrong/not complete.
  2. 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   

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Kristina Zvonar Brkić Feb 11, 2021
1. 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.

Yes, you are right.

2. 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?

Parts and components are covered in EU MDR 2017/745 in the:

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Feb 09, 2021

Feb 11, 2021