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  • 1.  completion of CER for Medical Devices, who is authorized?

    Posted 19-Jan-2018 14:58
    Hello all;

    Can someone shed some light on what is required of the individual completing a medical device CER? Do you need to have some type of licence in order for your CER to be considered acceptable/valid? If so, where can i find a listing of those requirements? Are these requiremetns different depending on your device class?

    Thank you for the help,
    Elizabeth Zak

    ------------------------------
    Elizabeth Zak
    Lumitex Inc.
    Strongsville OH
    United States
    ------------------------------


  • 2.  RE: completion of CER for Medical Devices, who is authorized?

    Posted 20-Jan-2018 08:33
    Elizabeth,

    As usual, the answer is "it depends".  Factors to consider are the risk profile of the device, the experience with the device, the indication or condition in which the device would be used, and the novelty (uniqueness) of the device.   For instance, if you have a lower risk device with a long history of use and there are multiple devices of the type (e.g. Foley catheters, gauze dressings, hypodermic needles/syringes), I have seen CERs prepared by non-medical staff such as engineers, regulatory personnel, etc.  On the other hand, a high risk device used or a device used in treating a critical condition (e.g. carotid stents, atherectomy catheters) or newer devices with no/few other of the type (e.g. VADs, continuous glucose monitoring) would require inclusion of medical staff on the team to prepare the CER.  In all cases, the final CER should at least be reviewed by an appropriate medical professional (RN, CRNA, MD) who signs off on the final product.  For the lower risk devices and/or smaller entities, this can often be satisfied by a consultant.

    Regards,
    James




    Original Message


  • 3.  RE: completion of CER for Medical Devices, who is authorized?

    Posted 22-Jan-2018 19:30
    Hi Elizabeth

    This has been interesting to watch from Down Under, where TGA has had stricter requirements than Europe for a long time - but the new MDR now leapfrogs TGA's position.

    The new European MEDDEV requires a team approach, with the lead reviewer being the clinical professional.  This means you  need to build in the team contributions and sign offs into your document control system for release of the CER.

    In Australia - TGA have always required the CER be either directly written by or at least reviewed and endorsed by an appropriate clinician.  Reality is that clinicians don't have the time or the background knowledge to write what is a regulatory document.  Actual practice is that the CER is frequently written by a company product specialist or by a consultant, and then reviewed by the "appropriate" clinician. 

    What's appropriate depends on the device.  We have used surgeons for implants, a radiographer for an X-Ray machine, and a paramedic for a portable incubator.  
    Original Message------

    Hello all;

    Can someone shed some light on what is required of the individual completing a medical device CER? Do you need to have some type of licence in order for your CER to be considered acceptable/valid? If so, where can i find a listing of those requirements? Are these requiremetns different depending on your device class?

    Thank you for the help,
    Elizabeth Zak

    ------------------------------
    Elizabeth Zak
    Lumitex Inc.
    Strongsville OH
    United States
    ------------------------------




    ------------------------------
    Arthur Brandwood PhD FRAPS
    Founder and Principal Consultant
    Brandwood Biomedical
    Sydney, Australia
    ------------------------------

    Original Message


  • 4.  RE: completion of CER for Medical Devices, who is authorized?

    Posted 22-Jan-2018 15:01

    Hi Elizabeth,

    This is described in Section 6.4 of MEDDEV 2.7/1 Rev 4: Who should perform the clinical evaluation?.

    "The clinical evaluation should be conducted by a suitably qualified individual or a team".

    Who performs the clinical evaluation depends on many factors relating to:

    • The device in question (medical field, classification, risk profile, design and materials etc.)
    • Why the clinical evaluation is being performed
    • The manufacturer's own perspective and judgement

    Finding one person with the time, experience, expertise and knowledge to fulfil every aspect of what the evaluator is required to do is possible but highly unlikely in most circumstances.

    This is how we (CROMSOURCE) perform clinical evaluations for our clients:

    Recommendation (Section 6.4 of MEDDEV 2.7.1 rev 4)

    "The clinical evaluation should be conducted by a suitably qualified individual or a team"

    • As a general principle, the evaluators should possess knowledge of the following:

    - research methodology;  information management; regulatory requirements; and medical writing.

    Experienced CER writer at CROMSOURCE

    • With respect to the particular device under evaluation, the evaluators should in addition have knowledge of:

    - the device technology and its application;

    Manufacturer's representative joins project kick-off meeting to train the CER writer on the device under evaluation;

    Manufacturer's representative reviews the final CER

     

    - diagnosis and management of the conditions intended to be diagnosed or managed by the device, medical alternatives, treatment standards (e.g. specialist clinical expertise in the relevant medical specialty)."

    The CER is reviewed by a clinical expert at CROMSOURCE

     

     

     
    Hope this helps,
    Beata



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    Beata Wilkinson
    Kenilworth
    United Kingdom
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    Original Message


  • 5.  RE: completion of CER for Medical Devices, who is authorized?

    Posted 22-Jan-2018 17:46

    Great information on author and required training for CERs. I've another relative question: Is there a requirement to place a separate section for Usability Studies in the Technical File?; Are Usability Studies required or expected for Class IIb devices? I know they are required and standard for 510(k) submissions for some devices.

    ------------------------------
    [Ponzelle [Royster] [RAC]
    [Manager QA / RA, US & Canadian Region]
    [Sol-Millennium Medical, Inc.]
    [Lawrenceville, [GA]
    [USA]
    ------------------------------

    Original Message


  • 6.  RE: completion of CER for Medical Devices, who is authorized?

    Posted 22-Jan-2018 19:36
    ​Elizabeth, if you are asking what is required to meet the criteria in MEDDEV 2.7.1(Rev 4) 6.4, I would agree that "it depends," but I'd say it depends mostly on what the reviewing notified body thinks is required to meet these criteria.

    On the other hand, if you are really asking what is required for the CER to be accepted to support certification, that depends more on how closely the NB will scrutinize the CER to determine whether it meets whatever criteria it thinks it should meet. In my limited experience, this depends largely on the risk classification, somewhat on whether the review is for initial certification or for re-certification by the same NB that certified it originally, and also on the NB and the auditor.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


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