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  • 1.  Notified Body Minor Observation - Clinical Evaluation Report

    Posted 24-Jan-2013 09:44

    I suggest you review Annex X of the MDD. The directive has changed and requires that a clinician review your Clinical Evaluation and that person should sign as objective evidence that the requirement has been met.

    MEDDEV documents that are helpful are:
    MEDDEV 2.7.1 (2003) Evaluation of Clinical Data which is the guide for manufacturers and notified bodies

    Hope that helps.
    -------------------------------------------
    Cathy Behrendt
    Regulatory Manager
    Victor NY
    United States
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  • 2.  RE:Notified Body Minor Observation - Clinical Evaluation Report

    Posted 25-Jan-2013 02:42
    Dear Cathy,

    thanks for the hint. MEDDEV 2.7.1 Rev 3 states in section

    5.3 Who should perform the clinical evaluation?

    The clinical evaluation should be conducted by a suitably qualified individual or individuals.
    A manufacturer must be able to justify the choice of the evaluator(s) through reference to
    qualifications and documented experience.
    As a general principle, evaluators should possess knowledge of the following:
    · the device technology and its application;
    · research methodology (clinical investigation design and biostatistics); and
    · diagnosis and management of the conditions intended to be treated or diagnosed by
    the device.

    So do you simply attach a CV to the clinicla evaluation docment or also a section to jusitfy the qualification for the specific product / tasks?

    Best Regards

    -------------------------------------------
    Alexander Schwiersch
    Brainlab AG
    Feldkirchen
    Germany
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    Original Message


  • 3.  RE:Notified Body Minor Observation - Clinical Evaluation Report

    Posted 25-Jan-2013 03:26
    Hi Alexander,
    we include a statement why an author was chosen. But we keep it as simple as this:
    Author A was chosen, because of his/her expertise in data retrieval. Author B was chosen because he/she is an expert in the area of product application.

    It does not hurt to state this.

    We also attach modified CV's. (not including all education, but showing the expertise)
    I have not heard from anyone before that had privacy concerns when attaching CV to a clinical evaluation but maybe you can avoid this by not naming it CV?! Just an idea...

    If that is not enough to protect privacy data, you could probably keep the CV's on file and just claim that you have the evidence of qualification at hand when needed. It is funny, though, because many experts have their CV's available online, so it would not really make sense to protect it. If your author agrees to attach the CV, this should be fine.

    -------------------------------------------
    Florian Tolkmitt
    sfm medical devices GmbH
    Germany
    florian.tolkmitt@sfm.de
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    Original Message