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Clinical Evaluation report

  • 1.  Clinical Evaluation report

    Posted 05-Mar-2017 23:34

    Hi,

     

    Would anyone in the group give me the reference to writers for Clinical Evaluation Report . Has anybody faced a recent Notified body audit , have they started reviewing the CERs as per the recent MEDDEV 2.7/1 revision 4?

     

    Thanks & Regards,

     

    Rashmi Pillay

    Regulatory Affairs Associate

    Ellex Medical
    82 Gilbert Street, Adelaide SA, 5000
    T + 61 8 7074 8105
    F +61 8 8104 5231

    rpillay@ellex.com

     



  • 2.  RE: Clinical Evaluation report

    Posted 06-Mar-2017 08:11
    Good Day.   The NB audits do not generally provoke a review of the CER.  I have found the review is prompted by the re-up of the CE mark certificate.  An update to your SOP is  also in order to reflect the changes.   For a writer - I would find a consultant who has had experience with your type of device, otherwise, do it internally.  However, I have written CERs internally (to rev 4) and have found they take an inordinate amount of time even with an understanding of the product.  Hence, an outside author would be great should your company want to foot the bill.  What do you think - $8 to 12k - depending on the type of device?  I think this would be a great business in and of itself.

    Mary Ann.


    ------------------------------
    Mary Ann Greenawalt
    Regulatory Affairs
    ------------------------------

    Original Message


  • 3.  RE: Clinical Evaluation report

    Posted 07-Mar-2017 03:31
    Good morning

    I'm working about 30% of my time as an accredited auditor and dossier reviewer for a Notified Body (EN ISO 13485 and MDD). Our internal policy is that for new CERs (including significant revisions) we only accept them if they are performed in accordance with revision 4 of MEDDEV 2.7/1. Furthermore we expect to see a plan (e.g. as part of the management review) for when the "old" ones are updated to be compliant with revision 4 as well. Other Notified Bodies may have different policies.

    We also regularly check CERs during re-certification and surveillance audits as part of ISO 13485, section 7.3.7 design validation. However, due to the limited time this can't be a thorough review, it's more an assessment that the CERs are kept up to date and (e.g.) are aligned with the risk management file and labeling.

    The time required to write a high quality CER is often underestimated. Of course it very much depends on the product but based on our experience of more than 50 CERs that my consulting company wrote for clients we see an average of about 120-160 hours.

    Cheers, Beat


    ------------------------------
    Beat U. Steffen
    Founder, CEO
    confinis ag
    Duedingen
    Switzerland
    ------------------------------

    Original Message


  • 4.  RE: Clinical Evaluation report

    Posted 07-Mar-2017 12:30
    Beat,

    The time required to write a high quality CER is often underestimated. Of course it very much depends on the product but based on our experience of more than 50 CERs that my consulting company wrote for clients we see an average of about 120-160 hours.

    As for your number of hours, it is agreeable from my perspective/experience.  I've been in ranges from 80-160 hrs. 

    I do CERs on referral based only for eye/ophthalmology-related, cardio(vascular), orthopedic, radiofrequency (RF) devices including IVDs.

    D



    Original Message


  • 5.  RE: Clinical Evaluation report

    Posted 06-Mar-2017 08:44
    Hello.  Recently participated in a NB Technical Assessment visit.  CERs are being reviewed in accordance with revision 4.  

    ------------------------------
    Michael Dawson
    Sr. Director of RA
    Parsippany, NJ

    ------------------------------

    Original Message


  • 6.  RE: Clinical Evaluation report

    Posted 06-Mar-2017 09:17
    I write many CERs each year.  All of my clients are now writing to Revision 4.  Their NBs are requiring it.  Also, an audit CAN trigger review of a CER.  Several clients work to ensure their CERs are up to date prior to an audit.  In rare cases, they can communicate with their NB to learn which products will be the subject of the audit.

    ------------------------------
    Karen Bannick MA, RAC, FRAPS
    Principal & Founder
    Bannick Consulting LLC
    karen@bannickconsulting.com
    ------------------------------

    Original Message


  • 7.  RE: Clinical Evaluation report

    Posted 06-Mar-2017 11:07

    Rashmi,

     

    I have reviewers requiring revision 4 for both new products AND revisions to dossiers.  I would recommend contacting Karen Bannick at Bannick Consulting (karen@bannickconsulting.com) if you need help with a CER.

     

    Cheers,

    Melissa 

     

     

    Melissa Walker, MS, RAC, FRAPS

    President & CTO

    Graematter, Inc.

    1324 Clarkson Clayton Ctr

    St Louis, MO  63011

    mwalker@graematter.com

    Office: 636-405-7498

    Cell: 314-753-7790

    Fax: 702-920-8509

     

    Graematter

    Think intelligence, not information

    Think Graematter

     




    Original Message


  • 8.  RE: Clinical Evaluation report

    Posted 07-Mar-2017 15:28
    From recent audit experience, I can confirm that Notified Bodies are reviewing to Rev. 4 in audits. 

    ------------------------------
    Maham Ansari, MS, RAC
    Director, Regulatory Affairs
    Synaptive Medical
    Toronto ON

    ------------------------------

    Original Message


  • 9.  RE: Clinical Evaluation report

    Posted 06-Mar-2017 23:39
    The criteria for evaluators are specified in rev 4 section 6.4 (advanced degree, 5 years exp, able to understand stats, biomed research, medical literature, etc), often a team approach is used with a qualified medical professional who has or is using the device in practice required. Yes, we have worked with many different notified bodies as they review CERS for CE mark under the rev 4 guideline.

    ------------------------------
    Joy Frestedt PHD, CPI, RAC, FRAPS
    President and CEO
    Frestedt Incorporated
    Saint Louis Park MN
    United States
    612-219-9982
    jf@frestedt.com
    ------------------------------

    Original Message


  • 10.  RE: Clinical Evaluation report

    Posted 07-Mar-2017 00:22
    I can also confirm that NBs have started reviewing CERs to Rev 4.   They might review your CERs during your next annual audit, or they might not.  The level of review is also unpredictable, because the general quality of auditing by NBs is variable.  Plus NBs have a lot on their plates (and minds) these days; how much time they have had to train auditors on Rev 4, who can say.

    I think some smaller companies will make a considered decision not to update their CERs to Rev 4 until the failure to have done so becomes an NB audit finding.  At that point, the NB will typically give you some period of time (perhaps until the next audit) to correct the deficiencies.  My most recent suggestion to a client who was considering this approach was to update at least one of their key CERs to Rev 4, so that, if the NB does audit their CERs, they would get feedback on whether their idea of a CER that conformed to Rev 4 was the same as that of their NB, rather than just being told that their CERs have not been updated to Rev 4, which they already knew.  (My philosophy is that if you are going to pay fees to an NB, you should strive to get as much value from the relationship as possible, and no new information represents no value.)

    I would be less inclined to recommend this approach for certificate renewal, but that again is a business decision.  Before making it, I would take a hard look at how the MDR is going to affect your products coming up for renewal in the next year or two.  It could work in your favor, or not.



    ------------------------------
    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


  • 11.  RE: Clinical Evaluation report

    Posted 07-Mar-2017 09:45
    I must add that any time and cost estimates for CERs based on prior experience tell you more about the scope of the prior experience than the time and cost required to prepare a CER.

    The primary determinant of the time required to prepare a CER is most commonly the quality of the information the company has available and the organizational ability of the company to provide that information to whoever is preparing the CER.  Other factors are the amount and quality of the clinical data to be incorporated into the CER.  There is potential for significant variability in all of these factors.  Trust me, I know. :)

    ------------------------------
    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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