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Non-applicable clauses for supplier of component for medical device

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Guest user Created:   Jan 18, 2021 Last commented:   Jan 20, 2021

Non-applicable clauses for supplier of component for medical device

As a supplier of component for medical device, which clauses will be not applicable for us?

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Kristina Zvonar Brkić Jan 20, 2021

I do not have enough information here, but the following requirements can be marked as non-applicable :

  • 6.4.2 Contamination control – if it is no necessary to have special control of the work environment during production
  • 7.5.2 Cleanliness of the product - if it is no necessary to monitor cleanliness of the product, if it is not sterile
  • 7.5.3 Installation activities - if your component does not need installation
  • 7.5.4 Service activities – if your comnponent does not need service
  • 7.5.5 Particular requirements for sterile medical devices – if your component does not need to be sterile
  • 7.5.7 Particular requirements for validation of processes for sterilization and sterile barier systems - if your component does not need to be sterile

Maybe there are some more requirements that can be marked as non-applicable, but for defining that I need more information regarding the product.

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Jan 18, 2021

Jan 20, 2021