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MDR & Document retention period

  • 1.  MDR & Document retention period

    This message was posted by a user wishing to remain anonymous
    Posted 15-Dec-2021 13:43
    This message was posted by a user wishing to remain anonymous

    Hi,

    Does anyone know if MDR 2017/745 has a requirement for a document retention period? 

    Thanks!


  • 2.  RE: MDR & Document retention period

    Posted 15-Dec-2021 15:38
    Edited by Kevin Randall 15-Dec-2021 15:40
    Indeed, there is. For example, see Article 10 (General obligations of manufacturers) section 8 stating that manufacturers shall keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements, issued in accordance with Article 56, available for the competent authorities for a period of at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market. In the case of implantable devices, the period shall be at least 15 years after the last device has been placed on the market.

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    Kevin Randall, ASQ CQA, RAC (Europe, Canada, U.S.)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 3.  RE: MDR & Document retention period

    This message was posted by a user wishing to remain anonymous
    Posted 20-Dec-2021 10:40
    This message was posted by a user wishing to remain anonymous

    Thank you Kevin! I knew it had to be there somewhere.
    Original Message


  • 4.  RE: MDR & Document retention period

    This message was posted by a user wishing to remain anonymous
    Posted 20-Dec-2021 10:41
    This message was posted by a user wishing to remain anonymous

    Thanks again!
    Original Message


  • 5.  RE: MDR & Document retention period

    This message was posted by a user wishing to remain anonymous
    Posted 20-Dec-2021 10:41
    This message was posted by a user wishing to remain anonymous

    Dear Kevin,

    Thank you for your answer on this topic.

    Can I ask another question: what is the period documentation concerning complaints (and it's returned products) should be kept?

    And there is another question bothering me:
    Can products (implantable devices) be scrapped after finding the root cause of the complaint or should they be retained similar to the document period?


    Original Message


  • 6.  RE: MDR & Document retention period

    Posted 05-Jan-2022 13:29
    Edited by Kevin Randall 05-Jan-2022 13:30
    Hey Anon,

    My apologies for the delayed response.  If you as a manufacturer hold a valid EN ISO 13485 certificate as part of your EU MDR Article 10(9) quality management system conformity efforts, then the record retention period for complaint handling records is generally governed by the fifth paragraph of clause 4.2.5 of EN ISO 13485.  But if you as a manufacturer don't hold a valid EN ISO 13485 certificate, then you have the liberty to prescribe an appropriate complaint record retention period commensurate with the risk and complexity of the subject device(s), in which case I would recommend just mimicking the aforesaid EN ISO 13485 approach unless the risk and complexity of the subject device(s) warrant something different.

    I know of no blanket provision in the EU MDR prohibiting the scrapping of complaint samples (implantable or otherwise) after finding the root cause in the complaint evaluation/investigation.  That said, Article 89 (analysis of serious incidents and FSCA) essentially forces the keeping of retention samples, at least for a period of time, in order to comply with that Article's prohibition against adversely affecting the competent authorities' abilities to evaluate the causes of the incident.  But once the competent authority(s) are satisfied with the root cause assessment and don't expect further evaluation, then your policy for whether to thereafter keep the complaint sample(s) needs to be based on the risk and complexity of the subject device, as well as on advice from legal counsel.

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 7.  RE: MDR & Document retention period

    Posted 11-Jan-2022 09:48
    In the example provided the affected products  were implantable devices. In the case that the complaint devices are such that have been explanted (e.g. because of premature failure of a device), the question if the device can be scrapped is much more complex to answer as the national laws in the member states of the European Union need to be considered. Implanted devices can become property of the patient with the implantation and as such, if a manufacturer destroys or scraps the devices, the manufacturer needs to ensure that the property owner (typically the patient) is informed and has agreed. See e.g. in Germany Art 72, § 72 (6) of the MPDG.



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    Markus Poettker
    Zug
    Switzerland
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    Original Message


  • 8.  RE: MDR & Document retention period

    This message was posted by a user wishing to remain anonymous
    Posted 24-Jan-2022 12:37
    This message was posted by a user wishing to remain anonymous

    Hello Markus ,

    As per your comment before destruction of complaint sample is it required to take patient consent.
    Is it legal law mentioned somewhere? Is it applicable anywhere in the MDR 2017?
    Original Message


  • 9.  RE: MDR & Document retention period

    Posted 16-Dec-2021 15:11

    For manufacturers see Art. 10(8). For the AR, see Art. 11(3)(b). For the Importer see Art. 13(9). For systems and procedure packs, see Art. 22(5). For Economic Operators, see Art. 25(2). For Eudamed personal data see Art. 33(6). See also Annex IX(7), Annex X(7), and Annex XI(9).



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


  • 10.  RE: MDR & Document retention period

    This message was posted by a user wishing to remain anonymous
    Posted 20-Dec-2021 10:41
    This message was posted by a user wishing to remain anonymous

    Thank you so much!
    Original Message


  • 11.  RE: MDR & Document retention period

    This message was posted by a user wishing to remain anonymous
    Posted 10-Jan-2022 12:28
    This message was posted by a user wishing to remain anonymous

    Hi, 

    Also, see Annex Chapter III, and note that the manufacturer needs to have a process in place to provide the documentation subject to doc retention to the CA in case of bankrupcy. This is a requirement for the manufacturer, that in my opinion, is a bit disguised since the intent of the section is to impose a requirement on the CA.

    BR, 

    A
    Original Message


  • 12.  RE: MDR & Document retention period

    This message was posted by a user wishing to remain anonymous
    Posted 25-Jan-2022 10:44
    This message was posted by a user wishing to remain anonymous

    Hello-
    I was hoping to jump in on this thread with a similar question about document retention in regards to a critical supplier. We have been working to update our supplier agreement with this particular supplier to state they retain documents regarding our particular material for a period of 10 years. They have so far refused to agree to retain documents for this long. Is the 10 yr. requirement applicable to them? IF so, any suggestions for compliance? Can we request the documents from them and keep them ourselves?
    Original Message


  • 13.  RE: MDR & Document retention period

    Posted 25-Jan-2022 15:43
    Edited by Kevin Randall 25-Jan-2022 17:18

    Short answer: Yes, you definitely can (and in your scenario, must) request the documents from the "critical supplier" and keep them yourself.  See basis below.

    First, the EU MDR makes no direct mention of a "critical supplier".  And because I've seen different folks have different understandings of what is meant by "critical supplier" (even amongst Notified Bodies even though that term has a formal definition in NBOG guidance), it is safest to apply the most legislatively proper answer.  Specifically, regarding a "critical supplier", such an entity (whatever its type of operation) would only become directly subject to the EU MDR and its record retention requirements if it is (notwithstanding Notified Bodies and Competent Authorities) an EU MDR-defined Economic Operator:  manufacturer, authorised representative, importer, distributor, or system/procedure packer/sterilizer.

    I'll presume for now that "critical supplier" in your case relates instead, let's say, to your contract manufacturer or contract designer who doesn't actually meet the EU MDR's economic operator category (and who thus is not directly subject to the EU MDR).  And I'll presume that you're the manufacturer.  In that scenario, I next recommend referring back to my preceding post about the potential governance of EN ISO 13485 or lack thereof.  Also note the EN ISO 13485 clause 4.1.5 requirement (or equivalent that needs to be present in a non-EN ISO 13485 QMS) for retaining ultimate responsibility/accountability over outsourced processes.

    From there, your (the EU MDR-regulated economic operator's) QMS needs to assure that any EU MDR-required economic operator records being generated by the critical supplier on your (the economic operator's) behalf are kept and available (either by the supplier or by you) for the required duration.  If the supplier refuses, then your only choice is to be sure the supplier provides the records to you for your required economic operator retention.  EU MDR Article 10(9) third paragraph indent (d) is the basis for your flexibility to realize your required record retention either directly yourself or by having it done on your behalf by your critical supplier.



    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


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