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  • 1.  EU Clinical evaluation: Identical Devices vs. "Equivalent" Devices

    Posted 21-Nov-2017 19:00
    A manufacturer has clinical data/literature for two versions of its device: Version A (original version) and Version B (resulting from a design change).  ​

    When doing a European Clinical Evaluation Report (CER) per MEDDEV 2.7.1 Rev 4 for Version B, can Version A (and its corresponding data) still be recognized as the identical device (vis-à-vis category D1 per MEDDEV 2.7.1 Rev 3), or does Version A instead need to be categorized/justified as an "equivalent" device (i.e., category D2)?

    If the "equivalent" device route, then what if the design change was a material change, thereby causing Version B to falter in regards to fulfilling the biological equivalence criterion (i.e., MEDDEV 2.7.1 Rev 4 Appendix A1)?

    Any thoughts/comments are appreciated!

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    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com
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  • 2.  RE: EU Clinical evaluation: Identical Devices vs. "Equivalent" Devices

    Posted 21-Nov-2017 19:55
    Hi Kevin,

    I have the same question for a product that I am working on.  I will be very interested to see the responses.


    Sincerely,

    John Beasley, RAC (US)
    Founding Member and Senior Consultant
    MedTech Review, LLC
    www.medtechreview.com
    www.linkedin.com/in/medtechreview





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    Original Message


  • 3.  RE: EU Clinical evaluation: Identical Devices vs. "Equivalent" Devices

    Posted 22-Nov-2017 10:02
    ​Hi Kevin, my understanding is that Version A is considered the equivalent device based on Rev 4 of the guidance. Any novelties in design changes need to be assessed for benefit-risk ratio and if there are any unanswered questions in regards to the differences from Version A and Version B, further studies such as a clinical investigation and/or PMCF may be required. It depends on your findings in your clinical evaluation process/procedure, and based on Stage 0 of scoping the clinical evaluation.

    For the biological characteristics section, in comparing the equivalent device to the subject device, list the exact biological differences and assess whether or not the differences are expected to affect the benefit-risk ratio related to safety of the device. In example, do the material changes mean that Version B may cause a greater risk than Version A? Use any biocompatibility testing for justification.

    Hope this helps!

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    Sophia
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    Original Message


  • 4.  RE: EU Clinical evaluation: Identical Devices vs. "Equivalent" Devices

    This message was posted by a user wishing to remain anonymous
    Posted 22-Nov-2017 11:45
    This message was posted by a user wishing to remain anonymous

    ​Hi Kevin,

    is Version B CE makred? If not, then the purpose of the CER is to gain the CE mark, right? Therefore, you need to demonsrate that the risk-benefit profile of Version B complies with the Essential Requirements. First, you need to figure out if the design change affects the risk-benefit profile of the device. If not, then Version A is equivalent to Version B, and you have to demonstrate that the material changes neither affect the safety nor clinical performance of the device. So you would categorize Version A data sets "D2". If the benefit-risk profile was affected, you must establish Version B's benefit-risk profile and you demonstrate that it complies with the Essential Requirements. If you now use Version A data sets, you would categorize them D3 (other device).

    It would never be the D1 (same device) because Version B is not Version A; Version B could be equivalent to Version A (i.e., the benefit-risk profile is identical) or not. So the real question is, did the design change affect the safety or clinical performance of the deive.

    I hope that helps.


    Original Message


  • 5.  RE: EU Clinical evaluation: Identical Devices vs. "Equivalent" Devices

    Posted 22-Nov-2017 16:01
    Good Evening,

    I would consider the clinical aspects of the change.
    If the change in the material has no clinical relevance, (has no effect on the operation/use of the device)
    • the raw material belongs to the same or similar group of compounds,
    • the device's biocompatibility is proven,
    • the device's physical or other properties, which are important for the clinical application are similar,
    • the device's the clinically relevant characteristics are within a justifiable normal range (elasticity, compression power, size, generated tension, such like)

    I would define the change as minor. This kind of clinical equivalency of designs should be proved by appropriate bench tests or clinical studies. Probably better to define this in an SOP on Compilation of clinical evaluation reports, where the evaluation criteria/principles are defined and justified appropriately. This would ease the work of the auditor, I guess.

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    Peter Mikó M.D
    ArtPharm Ltd.
    Gyermely
    Hungary
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    Original Message


  • 6.  RE: EU Clinical evaluation: Identical Devices vs. "Equivalent" Devices

    Posted 22-Nov-2017 16:26
    Hi Kevin,

    If the "equivalent" device route, then what if the design change was a material change, thereby causing Version B to falter in regards to fulfilling the biological equivalence criterion (i.e., MEDDEV 2.7.1 Rev 4 Appendix A1)?

    If such material change can't be addressed by other means for CE mark and CER purposes, a clinical investigation(s) should be considered as new clinical data would be most likely needed. 

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    REGULATORY DOCTOR
    Phone (Toll-Free): 1-(800) 321-8567

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    Original Message


  • 7.  RE: EU Clinical evaluation: Identical Devices vs. "Equivalent" Devices

    Posted 23-Nov-2017 18:55

    There are a number of issues here for which caution is required.

     

    Many people confuse the clinical evaluation process with the clinical evaluation report. The report is one step in the process; conflating them can lead to confusion.

     

    It is important to recognize the location of the clinical evaluation process in the device life-cycle. The clinical evaluation process is part of applying the CE Mark on the device. In this case, I infer that Version A has a CE Mark under the MDD. However, Version B does not have a CE Mark, since the clinical evaluation is not complete.

     

    The clinical evaluation process is a requirement of MDD Annex X, Clause 1. MedDev 2.7.1 Rev. 3 and Rev. 4 provide methodologies to perform the process.

     

    While the MedDev are guidance documents and not required, most people take them as requirements; I'll use that approach. As a requirement, MedDev 2.7.1 Rev. 4 has an effective date of July 1, 2016. In practice this means that any MDD Declaration of Conformity from July 1, 2016 is supported by a clinical evaluation using the process in MedDev 2.7.1 Rev. 4.

     

    The role of the clinical evaluation process is important. Following MDD Annex X Clause 1.1 clinical evaluation confirms conformity with the requirements of:

    • MDD Annex I Section 1 under normal use conditions
    • MDD Annex I Section 3 under normal use conditions
    • MDD Annex I Section 6 related to side-effects
    • MDD Annex I Section 6 related to the acceptability of the benefit/risk ratio.

     

    I infer that Device A satisfies these requirements based on a clinical evaluation.

     

    Since Version B does not have a CE Mark, MedDev 2.7.1 Rev. 4 defines the applicable clinical evaluation process. One step in the clinical evaluation process determines if there an equivalent device about which one could use information to support the MDD Annex X conclusion. Note that MedDev 2.7.1 Rev. 4 does not require an equivalent device.

     

    Since Version A does have a CE Mark, there may be additional information on Version A from post-market surveillance (PMS), Post-market Clinical Follow Up (PMCF), or Post-production information from EN ISO 14971:2012 Clause 9.

     

    You ask, to paraphrase, whether in the clinical evaluation of Version B can Version A be considered as an identical device under MEDDEV 2.7.1 Rev 3. My answer is no. Since Rev. 3 is obsolete nothing in Rev. 3 applies to the clinical evaluation of Version B under Rev. 4. For Version B you must use the Rev. 4 process only.

     

    Under the Rev. 4 process applied to Version B, you could evaluate Version A to determine if it is equivalent to Version B. If some of the data Version A data could apply, this makes the clinical evaluation process simpler. MEDDEV 2.7.1 Rev 4 Appendix A1 describes the process to determine whether Version A is equivalent to Version B.

     

    If the design change were a material change, thereby causing Version B to falter in regards to fulfilling the biological equivalence criterion (i.e., MEDDEV 2.7.1 Rev 4 Appendix A1), then you could not claim that Version B is equivalent to Version A.

     

    If Version A were not equivalent to Version B, however, much of the clinical evaluation data collected for Version A could also apply to Version B.

     

     



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    Dan O'Leary
    Swanzey NH
    United States
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    Original Message


  • 8.  RE: EU Clinical evaluation: Identical Devices vs. "Equivalent" Devices

    Posted 28-Nov-2017 10:30
    Edited by Marcelo Antunes 28-Nov-2017 10:37
    There's no "identifical"option on the Meddev, only the equivalent option, so you would need to show that A id equivalent to B, following the equivalency rules.

    Regarding changes, the first question to ask is - does the change modify results that rely on clinical data? If not, you may not need clinical data to show compliance, but you may need other data such as testing data (in the particular case, it seems you may need to re-evaluate the new device using 10993-1 and risk management).

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    Marcelo Antunes RAC
    Regulatory Strategy Consultant
    SQR Consulting
    Sao Paulo
    Brazil
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    Original Message


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