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  • 1.  Clinical Evaluation report

    Posted 14-Dec-2017 16:39
    ​Hi,

    Without any prior experience in preparing a CER / clinical background do you think one can attempt to prepare a CER ? How does one start off ? I am aware we have the EU clinical guidance for the same, however is there is a simplified version if I need to start from scratch.

    Regards,

    Rashmi

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    RashmiEllex MedicalAdelaideAustralia
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  • 2.  RE: Clinical Evaluation report

    Posted 15-Dec-2017 05:56
    Hi Rashmi, you have asked a tricky question! Of course anyone is capable of following the current guidance regarding clinical evaluation and CER requirements, but the ability of one person to create a successful document without any prior training or experience would be a big task. I am a free lance consultant with over 10 years of CER experience, I'm based in Brisbane, please feel free to contact me so I can help explain what would be required to prepare CERs for your company's devices. Kind Regards, Daniela (daniela@model-a.com.au)

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    Daniela Sanders
    VP Regulatory Affairs - Medical Devices
    Model Answers
    Brisbane
    Australia
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    Original Message


  • 3.  RE: Clinical Evaluation report

    Posted 16-Dec-2017 09:10
    ​
    Just a quick note to echo Daniella's comments.

    Also, I worked with Daniella for many years (when we were both in previous jobs), and I can confirm she has considerable experience and expertise in planning and writing CERs.  We have no relationship, other than having been somewhat distant coworkers in past work.

    Ted


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    Theodore Heise PhD RAC
    VP Regulatory Scientific Affairs
    MED Institute
    West Lafayette IN
    United States
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    Original Message


  • 4.  RE: Clinical Evaluation report

    Posted 17-Dec-2017 03:25
    Thanks Ted!

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    Daniela Sanders
    VP Regulatory Affairs - Medical Devices
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    Original Message


  • 5.  RE: Clinical Evaluation report

    Posted 18-Dec-2017 04:58
    Edited by Andrea Biasiucci 18-Dec-2017 04:58
    Hello Rashmi, 
    in my opinion if you do not currently have a clinical background nor prior experience you may want to familiarize with systematic literature searches as well as searches in the adverse events databases. There are a number of publications on how to perform systematic searches leading to reproducible output and high specificity of your searches (you can google for tutorials related to PubMed and Cochrane). The bottom line, though, is that in order to produce high quality CER you will need to build that clinical background in the areas where you want to specialize - this will be a very important aspect for your clients. 

    MEDDEV 2.7/1 guidance provides a very good framework for the execution of the clinical evaluation, but please remember that a CER is a very important document whose goal is to provide evidence on whether a certain device is safe and performs as intended, so its accuracy is of utmost importance. 

    Other very relevant documents for the clinical evaluation report and clinical investigations in general include Annex IX of the MDD 93/42 and the EN ISO 14155:2011. 

    I hope this is helpful for you.
    Good luck with your future professional endeavors!

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    Andrea Biasiucci, PhD
    Clinical and Regulatory Affairs Consultant
    confinis ag
    Düdingen (Switzerland)
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    Original Message


  • 6.  RE: Clinical Evaluation report

    Posted 18-Dec-2017 13:47
    Hi Rashmi,

    Agree with Andrea's comments. Is this a new undertaking for your company as a whole? In that case, the best approach is study the regulatory requirements and come up with an SOP and CER template that matches the company's thinking. This will be a cross functional effort involving RA, QA, compliance and most importantly clinical affairs. I think this is important to do whether or not you are outsourcing the CER writing, because there are details like frequency of updating CER and preferred literature search strategy that only you would know. You may also want to decide what revision of Meddev 2.71 you are going to use because as you may know, Rev 4 is very prescriptive and proving to be a challenge. 
    It is truly one of the most remarkable documents to create because of the extensiveness of information required to show your device is indeed doing what its supposed to be doing. Also important is to talk to your NB about what their expectations are, may be get their opinion on previous CERs that your company has done.

    PS: Rev 4 proposes a CER template that can be used, you can tweak it as you like. 

    Best regards,

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    Vidyalakshmi Jayaraman
    Regulatory Affairs Specialist
    MA, United States
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    Original Message


  • 7.  RE: Clinical Evaluation report

    Posted 19-Dec-2017 22:49
    ​The most "simplified" versions I've seen were all two pages long, written circa 2011, for a number of different Class I, II, and III devices, all of which were already CE Marked.  The notified body (one that will undoubtedly be recertified under the MDR) determined that these CERs didn't conform to Rev 3, and gave the company until the next annual audit to rewrite them.  At the next annual audit, they had not been rewritten, but a consulting firm had been found to rewrite them.  The notified body gave them another year.  I think they had been rewritten by the time of the next audit, and were considerably more than two pages long. Whether the NB determined that they conformed to Rev 3, I cannot say, but no certificates were withdrawn.

    In many cases, I think a CER is more about your regulatory and business strategy than your writing skills or the requirements of the MEDDEV.  If your CER will be part of a Class III design dossier submitted for NB review to support CE Marking, your company would do well to find a qualified and experienced regulatory consultant or medical writer to prepare it, or be prepared for a considerable delay in getting CE certification.  Otherwise, I'd have a heart-to-heart with your management, and see what they are willing to risk.  If your company is not a startup that is aiming to be acquired in the next 2-3 years, I think there is a lot of value in developing CER writing capabilities in-house, and this could be an opportunity to build that capability.  Whether you have the knowledge, experience, and the talent for it, I can't say, although the fact that you are looking for a simplified version might not bode well.  However, if your management is on board with you giving it your best shot before seeking external assistance, I wouldn't recommend against it.

    I would, however, recommend getting their willingness in writing, along with their clear understanding that your NB might not accept the results of your efforts, and its actions at that point cannot be predicted.

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    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
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    Original Message


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