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  • 1.  ISO 13485 :2016

    Posted 23-Jul-2017 05:38

    Hi ,


    Does anybody have an idea on :


    4.2.3 Medical Device File : Assume this refers to the Device Master Record requirements (FDA terminology) and not the Technical file as required for CE marking.


    7.3.7 Design development and validation and  Clinical evaluation requirement - what exactly is the requirement here , does it refer to a complete CER as per MEDDEV 2.7/1  ?


    Regards


    Rashmi



  • 2.  RE: ISO 13485 :2016

    Posted 23-Jul-2017 18:48

    ISO 13485:2016 (hereinafter "v2016") clause 4.2.3 (Medical Device File) is the updated v2016 content corresponding to ISO 13485:2003 clause 4.2.1, third paragraph. The basic requirements of that clause and File have customarily been interpreted to overlap with FDA's requirements for Device Master Records (DMR) as well as the requirements for European Union (EU) CE Mark Technical Documentation. For example, ISO 14969 (an ISO 13485:2003 guidance document, though withdrawn and not yet updated for v2016) directly states that this File corresponds in part with an FDA DMR or European Technical File.  And as described later in this post, ISO 14969 is still a relevant guidance document to be applied.

     

    With the addition of the v2016 4.2.3 requirement for the File to include a general description of the medical device and its intended use/purpose, the updated v2016 requirements now have additional overlap with European CE mark Technical Documentation requirements. Such overlap is driven in part by v2016 4.2.3's requirement for the Medical Device File to contain or reference evidence of conformity with corresponding "applicable regulatory requirements".  For example, if an ISO 13485:2016-registered manufacturer markets its non-GMP-exempt medical devices in the United States, then a DMR is an "applicable regulatory requirement" pursuant to FDA's 21 CFR 820.181.  Similarly, if an ISO 13485:2016-registered manufacturer markets its European Class I sterile, I measuring, IIa, IIb, or III medical devices in the EU via the full quality assurance conformity assessment route, then a European Technical file is an applicable regulatory requirement pursuant to, for example, the European Medical Devices Directive (MDD) 93/42/EEC Annex II, Section 3.2(c).

     

    As additional basis supporting these assertions, readers may also want to refer to Annex ZB of Europe's local version of v2016 (called "EN" ISO 13485:2016). Therein, Annex ZB directly correlates the v2016 Medical Device File with certain EC Technical Documentation requirements from MDD Annex II section 3.2(c).  But what we also know from Annex ZB is that v2016 4.2.3 Medical Device File requirements don't perfectly overlap with the MDD's Technical Documentation requirements.  Nor do they with FDA's 21 CFR 820.181. Therefore in practice, a fuller answer to Europe's Technical Documentation requirements can only be realized by application of v2016 4.2.3 combined with other v2016 clauses such as those for design and development files (v2016 clause 7.3.10). And the same dynamic exists regarding FDA's 21 CFR 820.181.

     

    Also, remember that a reference to EN ISO 13485:2016 has not yet been published (unless I missed it) in the Official Journal of the EU. Per EU rules, this technically means that EN ISO 13485:2016 is not yet allowed to be used as a harmonized standard for the purposes of MDD Article 5.  Consequently, EN ISO 13485:2012 [normatively equivalent to ISO 13485:2003 (which is why ISO 14969 is still relevant)] is still the official EU harmonized version of ISO 13485.  That said, the Notified Bodies may give you a different feeling on the matter as they grapple with the difficult scheduling challenges of our current tsunami of regulatory changes. 

     

    Finally, note that in the v2016 clause 7.3.7 requirement for clinical evaluation (or other performance evaluations), we again see the new pervasive v2016 language about "applicable regulatory requirements".  Therefore, if an ISO 13485:2016-registered manufacturer markets its medical devices in the EU, then MDD requirements such as Annex I (Chapter 1, Section 6a), or Annex II section 3.2(c), or Annex X, demand that the v2016 clause 7.3.7 clinical evaluation indeed be a full EU CER (i.e., per MEDDEV 2.7/1).

     

    Hope this helps,

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com
    Copyright 2017 by ComplianceAcuity, Inc. All rights reserved.
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  • 3.  RE: ISO 13485 :2016

    Posted 24-Jul-2017 07:33
    As to the second question you pose, your organization must determine the applicable regulatory requirements for clinical evaluation (or performance evaluation). In the US, there might be a requirement to provide this clinical information before your market release would be cleared or in the EU, the Notified Body may require this prior to allowing the CE mark to be applied. There are other geographies as well that can have requirements for this information before placing the medical device on the market.

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    Regards,
    Mark Swanson, ASQ CBA, CMQ/OE, CQE MBA
    Becker MN
    United States
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  • 4.  RE: ISO 13485 :2016

    Posted 24-Jul-2017 19:58
    ​OK, I just have to say this, can't help myself.

    I have never been able to find a reference to a "technical file" in the current MDD.  I have not yet looked for one in the MDR.

    ------------------------------
    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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  • 5.  RE: ISO 13485 :2016

    Posted 24-Jul-2017 20:26
    ​What a great question Julie!!  As I look back over my career, the term "Technical File" was always what I heard used, even by Notified Bodies, which is strange because, as you point out, the MDD doesn't actually use that terminology.  So I'm not sure where that language got started.

    In any event, a "Technical File" is what the MDD (93/42/EEC) calls "technical documentation".  For example, in Annex II, Section 7.2 where it says that, "...the notified body shall assess...the technical documentation as described in Section 3.2(c)..."

    In the new MDR 2017/745, the same terminology is used, for example in its Annex II entitled "TECHNICAL DOCUMENTATION".

    Best regards,

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com
    ------------------------------



  • 6.  RE: ISO 13485 :2016

    Posted 25-Jul-2017 05:35
    There is a context of Technical File in the NB MED 2.5.1/Rec 5.

    Regards
    Sreenu


  • 7.  RE: ISO 13485 :2016

    Posted 29-Jul-2017 15:30
    I really expected everyone to ignore this, but since there seems to be interest...

    This matter caught my attention years ago, with the (at the time, anyway) oft-repeated claim that the Class III's design dossier is "just its technical file."   I wasn't particularly knowledgeable about tech files (nor DHFs, DHRs, etc) back then, and still today they are not my strong suit.  However, that didn't jut seem right to me.

    The question has come up every now and then over the years, and sometimes it inspires me to do a bit more digging, if I have time at the moment.  It seems to be an old engineering term, having nothing to do with medical devices, as I found it in articles on the design and construction of both ships and buildings, some going back to the 40s.

    I also received an email from someone affiliated with an NB that suggested that the idea that the Class III design dossier was the device's technical file, and/or the general use of the term itself, tended to be more of a US thing. That makes sense if you are aware of the history of engineering generally, I think.  I also think that, when the EU rolled out the MDD, use of a familiar term served as sort of security blanket for US device engineers, not accustomed to demands by anyone by FDA, and so about to embark on uncharted waters.

    I've got an incomplete table somewhere in which I've tried to the concept of the technical file and design dossier as described by several guidance/agencies (GHTF, WHO) over the years.  Maybe some day I'll have enough pieces to put together a whole picture.

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



  • 8.  RE: ISO 13485 :2016

    Posted 25-Jul-2017 12:04
    ​Hi Julie,

    I've been asked that question before by those wanting to read the requirements for a technical file or design dossier, the other term commonly used, before reviewing what I drafted. Both the MDD and MDR use "technical documentation", which is why the STED format stands for summary of technical documentation. They added the "E" because the TLA STD was already taken. :-)

    No official use of the term "technical file" that I've ever seen.

    Design dossier was mentioned once in the MDD, but in the MDR it has become "application dossier", "marketing authorization dossier", or simply "dossier".

    Best regards,
    Kevin

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    Kevin Hawkins, RAC
    Director, Quality & Regulatory Affairs
    Portland OR
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