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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 23, 2022

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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Ria Rai Feb 22, 2022

Can you identify the source of the following para:

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

 

At the time of product discontunuation is there any regulation that makes it mandatory to inform customers of the product discontinuation and plan on maintaining product servicability?

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Kristina Zvonar Brkić Feb 23, 2022

It is covered in MDR 2017/745, Annex 9, section point 2.2 c): the procedures and techniques for monitoring, verifying, validating, and controlling the design of the devices and the corresponding documentation as well as the data and records arising from those procedures and techniques.

Those procedures and techniques shall specifically cover:

  • solutions for fulfilling the applicable specific requirements regarding design and construction, including appropriate pre-clinical evaluation, in particular, the requirements of Chapter II of Annex I,
  • solutions for fulfilling the applicable specific requirements regarding the information to be supplied with the device, in particular, the requirements of Chapter III of Annex I.

So yes, you need to inform the customers that you will not produce your medical device anymore, but that you will provde the spare parts or service for a lifetime. If you are unable to do so, then you must inform who I can contact for spare parts or for service.   

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Feb 09, 2021

Feb 23, 2022