Good Clinical Practice Guide
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Thread: CE marks on central lab materials

  1. #1

    CE marks on central lab materials

    Hi, Should materials (vacutainers, swabs etc) supplied by a central lab for use in a commercial drug trial in the UK have CE marks as appropriate?

  2. #2
    Forum Member
    Join Date
    May 2017
    Which codes of the CE marks do you mean?

  3. #3
    For a clinical investigation involving a non-CE-marked medical device (i.e. a new or substantially modified device, or an existing device with a new function, feature or material), or a CE-marked device being used for a new intended purpose, the sponsor is likely to require a Notice of No Objection from the MHRA prior to commencing a study.

    There are certain circumstances where use of a non-CE-marked device used within a healthcare establishment may not be covered by the provisions of the Medical Devices Regulations/Directives. Further advice on this can be found on the MHRA website.

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