Medical Device storage and shipment

• Anon
  22/01/2021 11:17

  Dear, Our sponsor is asking us (CRO) to assist with the storage and shipment of investigational medical devices to sites. I am wondering if there are any specific regulations/requirements we need to take into account besides general accountability procedures? Kind regards
• Colette McIntyre
  22/01/2021 11:21

  You will need to consider if there are any special handling or storage conditions which need to be maintained, if there are you will need to maintain records to confirm the required conditions have been maintained throughout the delivery and storage process.
• Juergen Kaetzler
  01/02/2021 07:01

  In addition to Colette's points you also need to be aware of specific national regulations. For example you have the "Ordincance on clinical trials on medical devices" (translation by me, not official) where section 2 has some requirements on labelling. >> Have an eye on the provisions in the contract too: you should only be responsible for transportation/shipment of the devices and not for any approval (e.g. release approval). Responsibilities should be clearly stated in the contract between you and the sponsor. >> ISO 14155 states in section 9.2.2. c) that investigational devices shall not be made available to the sites until all requirements to start the clinical investigation are met. Provisions for device accountability are set out in section 7.9 in the ISO 14155.

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