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ISO 13485-2016 VS EN ISO 13485-2016

  • 1.  ISO 13485-2016 VS EN ISO 13485-2016

    This message was posted by a user wishing to remain anonymous
    Posted 03-Jul-2019 11:18
    This message was posted by a user wishing to remain anonymous

    Dear RAPS members,

    I would like to understand the difference between ISO 13485-2016  and EN ISO 13485-2016 with regard to CE marking a class IIb and class III device in EU.

    The conformity assessment route requires full QMS and technical documentation preparation for class II and III. If ISO 13485 does not address all requirements of Article 10(9) so what would be the best approach? Is it true that a Notified Body may ask for compliance with  EN ISO 13485-2016  instead of ISO 13485-2016?

  • 2.  RE: ISO 13485-2016 VS EN ISO 13485-2016

    Posted 03-Jul-2019 11:59

    Because you mention Article 10(9), I infer your question is about the EU-MDR, not the EU-MDD.

    Also, since you ask about technical documentation, I infer your question is about full EU-MDR implementation, not the Article 120 Soft Transition.

    The problem is that there is no EU version of ISO 13485:2016 that applies to the regulations. The draft request for standardization asks for CEN to complete it by May 26, 2020. It will likely incorporate the issues raised in CEN/TR 17223:2016, so you need a copy of that now and start to update your QMS so you will be ready for May 26, 2020. If CEN completes the work on time, the EU standard would be EN ISO 13485:2020.

    In infer you intend to follow EU-MDR Annex IX. Note that Ann IX(2.3) says, "Where the manufacturer uses a harmonized standard or CS related to a quality management system, the notified body shall assess conformity with those standards or CS. The notified body shall assume that a quality management system which satisfies the relevant harmonized standards or CS conforms to the requirements covered by those standards or CS, unless it duly substantiates not doing so."

    Assuming the standardization process completes on time, the harmonization process starts. Given the experience with the EU-MDD harmonization process, the EU-MDR harmonization process could take three or more years. As a result, you will probably not have a harmonized standard or CS available when the NB conducts the audit.

    My recommendation is that you implement ISO 13485:2016 plus all the places in CEN/TR 17223:2016 where it identifies that ISO 13485:2016 only partially satisfies or does not satisfy the EU-MDR requirement. Similarly, follow CEN/TR 17223:2016 to help you complete you Annex IX application to the NB.

    Dan O'Leary CQA, CQE
    Swanzey NH
    United States

  • 3.  RE: ISO 13485-2016 VS EN ISO 13485-2016

    Posted 03-Jul-2019 12:32
    The 'EN' means that the standard is harmonized in the EU to a European directive or regulation. All EN standards need to be implemented by the EU 28 unaltered, meaning no country deviations are permitted, but not all standards are harmonized. At the moment, NO standards are harmonized to the EU MDR and EU IVDR as a

    standardization request need to be made by the EU commission to CEN to develop a harmonized standard. This harmonization process is critical as compliance with clauses of a standard confers, within the limits of the scope of the standard, a presumption of conformity with the corresponding Essential Requirements/General Safety and Performance Requirements of that directive or regulation.

    In response to your specific question regarding ISO 13485:2016 and EN ISO 13485:2016, if selling medical devices to the EU, you need to comply with the EN version, but outside of the EU the non-EN version is required. There is little to no difference in the content of the two, but NB will look for the EN version.

    Lena Cordie-Bancroft
    Victoria MN
    United States

  • 4.  RE: ISO 13485-2016 VS EN ISO 13485-2016

    Posted 03-Jul-2019 13:00


    I don't think the statement "The 'EN' means that the standard is harmonized in the EU to a European directive or regulation." is correct.

    The EN means that the standard is a European Norm. The nomenclature does not change for a harmonized standard. You cannot tell whether a standard is harmonized by looking at.

    An example of a CEN standard illustrates the distinction.

    The standard harmonized to the MDD is EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)

    The current standard is EN ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)


    EN ISO 11135:2014/FprA1 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/FDAM 1:2018)

    Notice that the current standard supersedes the harmonized standard which is now obsolete and has been for about seven years!

    This creates an awkward situation. Some NBs require the manufacturer to use the obsolete but harmonized standard. Other NBs require to use current standard, not the harmonized, because the current standard is the state of the art.

    Given the current problems with the MDD harmonization process, I do not have any confidence that the EU-MDR harmonization process will be effective.

    Dan O'Leary CQA, CQE
    Swanzey NH
    United States

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

    This message was posted by a user wishing to remain anonymous
    Posted 03-Jul-2019 16:12
    This message was posted by a user wishing to remain anonymous

    Thanks Dan and Lena. This is very helpful.

  • 6.  RE: ISO 13485-2016 VS EN ISO 13485-2016

    Posted 04-Jul-2019 03:13

    The EU Commission, requested on 26 June 2019, CEN (EU Committee for Standardization, EU equivalent to ISO) and CENELEC  (EU Committee for Electrotechnical Standardization, EU equivalent to IEC) draft revisions to existing standards, adaption of international standards, and new standards in support of MDR (2017/745) & IVDR (2017/746).

    EN ISO 13485:2016 + AC:2018 is the Proposed standard of the Request from the EU Commission to the European Standards Organizations (ESOs) CEN & CENELEC.  Note, that was published in Nov 2017 for the MDD & AIMDD list of Harmonized Standard thru the OJEU is EN ISO 13485:2016 + AC:2016.  I am not clear what the difference is for the AC's or just a typo.  Maybe someone else can explain within the forum.

    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328

  • 7.  RE: ISO 13485-2016 VS EN ISO 13485-2016

    Posted 04-Jul-2019 06:09

    This is another instance where the standardization process is ahead of the harmonization process. The CEN website lists EN ISO 13485:2016/AC:2018 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

    AC:2016 fixes typos in the tables in the Annexes but didn't fix them all. AC:2018 fixes more of them and is cumulative.

    Dan O'Leary CQA, CQE
    Swanzey NH
    United States

  • 8.  RE: ISO 13485-2016 VS EN ISO 13485-2016

    Posted 04-Jul-2019 07:58
    The EN prefix does NOT mean the standard iOS Harmonized. It only means one of the European standardization organizations, CEN (similar to ISO) or CENELEC (electrical standards like IEC) has approved a version of the standard. A standard must be published in the Official Journal of the EU to be Harmonized to a particular Directive or Regulation as cited in the publication. There is presently NO Harmonization process for the MDR / IVDR so no Harmonized Standards exist for these regulations. It likely that it will be some time before we see these new standards. All current standards will have to be revised to new version and submitted to the non-existent Harmonization process for consideration. The new version of ISO 14971:2019 has been submitted to CEN to be approved as a European Norm or standard. When approved by CEN it still must be submitted to Harmonization for approval. Following publication in the Official Journal you must still determine what the conditions of Harmonization might be as published.

    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Overland Park KS
    United States

  • 9.  RE: ISO 13485-2016 VS EN ISO 13485-2016

    Posted 04-Jul-2019 10:27

    Dear Anonymous, dear All,

    What an interesting discussion!  I would like to give this now a new spin in regards to the use of the harmonized standards for the compliance.

    One aspect, which needs to be known about harmonized standard is the Annex Z.  This Annex outlines the exact correlation to the law!  The European market relies on harmonization and provides harmonization with the new approach regulations (MDD, MDR etc.), which try to provide a set of requirements (Annex I) but those are not specific on how to comply.  The tool for compliance is supposed to be given by the harmonized standards (faster adoption of state-of-the-art solutions via the standard process then updating each time the law!).  Therefore, they are essential for the whole system. 

    The Annex Z shall be very precise because they provide a presumption of conformity to the legal requirements (a few years back CEN and CENELEC were heavily criticized not doing a good job with that and therefore most likely need more time for the Annex Z today).  Having stated that it needs to be noted that harmonized standards are not mandatory.  However, compliance with the law is!! 

    Consequently, there are two aspects to consider:

    1. If there are no harmonized standard check what is available to get the state-of-the-art compliance with the law. If a harmonized standard is outdated then certainly the latest and greatest standard may or even should be selected. Your compliance checklist could outline where the new standard provides better compliance and this should be supported with your risk assessment! Also, if a number of aspects may not be covered by a given standard the same applies for those aspects (Article 10. 9 has requirements which are definitely not covered and will not be covered by the EN ISO 13485!)!
    2. Selecting not complying to a harmonized standard is very well possible. Notified Bodies (NB) are not allowed to make standards mandatory.  However, not utilizing a harmonized standard may be difficult.  Let's take the EN IEC 601 series as an example.  These are safety standards and I guess if someone selects not to comply to it may blow up his risk assessment to the sky!!  And the bad news is that a NB would have to check all of that!  However, the good news is, if a particular requirement would prevent a greater benefit to the patient you have the freedom to deviate or ignore a standard or standard clause.  Again, the risk analysis must be very good and it most likely would have to be clinically tested.

    That currently harmonized standards are not available would not prevent to be in compliance with the law!  The system is open for that. One solution is to utilize a good checklist comparing the old requirements (MDD) with the new ones (MDR) and identify what are the difference.  Should you identify that a particular requirement indeed is the same then the solution adopted with the harmonized standard according to the MDD should be sufficient for the MDR requirement.  The harmonization process most likely will not change the standard.  The work is to get the Annex Z established, which in essence is a reference table.  And if the standard is not changing then you certainly should be in compliance with the MDR for at least those aspects. Now for any new requirement the current harmonized standard may as well provide a solution.  However, other option may be utilized and it is up to your QM and RM system to identify the right compliance solutions for your products. 

    The compliance document can be easily established but it is just a matter of time and certainly a good understanding of the requirements.  MDSS GmbH provides such document to its clients for the Annex I comparing the MDD with the MDR.  Simply contact us.

    Anonymous, it would be great if you could let me know whether the above information was helpful for you.

    Ludger Moeller
    President, MDSS GmbH

  • 10.  RE: ISO 13485-2016 VS EN ISO 13485-2016

    Posted 04-Jul-2019 10:49
    ​I believe this whole concept of Harmonized Standards needs a complete make-over. The harmonization process is unbelievably slow for almost zero added value. Often, it comes in addition to an already time consuming process for creating or revising the corresponding international standards. To me, it looks more like Occupational Therapy ("Beschäftigungstherapie") than a meaningful contribution to ensuring the continued safety and effectiveness of our medical technologies. It is my guess that all or most EU Member States and affiliated countries (like Switzerland) have voting rights and possibly committee members in the major international standards organizations (say, IEC and ISO) and therefore know well in advance what is coming our way. My suggestion is that by default an international standard (at least the ones commonly used throughout our whole industry) becomes the European Harmonized Standard three months after its issuance, unless within that timeframe a Europeanized version (with its Annexes-Z) is published. In addition, it is anyway in our best interest to move on to the latest editions of these international standards as soon as possible, but with a practicable (doable) transition time. With kindest regards,

    Ary Saaman
    Director, Regulatory Affairs

  • 11.  RE: ISO 13485-2016 VS EN ISO 13485-2016

    Posted 04-Jul-2019 13:01


    Thanks for clarifying! Yes, you are correct (that is what happens when in a rush to begin a long weekend...). All CEN standards are termed 'EN', but not all are harmonized. To be harmonized, there first needs to be a Standardization Request (mandate) from the European Commission to CEN/CENELEC. Then the annexes Z published in the standard, and finally a listing in the Official Journal of the European Union (OJEU).

    In the example you cite, you are correct that the superseded version of EN ISO 11135 (2007) is listed in the OJEU. The draft amendment A1 has been published as ISO 11135:2014/Amd 1:2018 by ISO in 2018, but has still not been issued by CEN (hence the FprEN designation), which should not happen (publication should occur at the same time in CEN and ISO) as these documents are aligned under the Vienna Agreement.

    You raise an interesting point regarding notified bodies. European standards when published, have a date of withdrawal (DoW) that is normally 6 months, but can be extended by CEN upon publication of the standard. This is the date that the new standard is in full force and the former version is declared obsolete. Regarding harmonization, generally the date of cessation of presumption of conformity will be the date of withdrawal. So it would be inappropriate to use a harmonized standard as such after it has been superseded (i.e. after the DoW). DoWs can be found by going to the CEN website and clicking on search standards; type in the standard number, then click on the standard. The information will be displayed on the right. In the case of EN ISO 11135:2014, the DoW is July 31, 2017.

     So I agree that there is some disconnect occurring here.

     As far as the EU MDR/IVDR process is concerned, there is still not a Standardization Request (mandate) for these regulations; there have been several drafts published but to date, nothing published. So we cannot even begin to harmonize any standard against these regulations without the mandate being in place. There have been rumours that the European Commission will not harmonize standards under the existing MDD/IVDD due to workload, and this was compounded by a legal case (James Elliott Construction Ltd v Irish Asphalt Ltd) that ultimately went to the European Courts of Justice (ECJ), who handed down its judgement in 2016 to imply that a harmonized standard was a provision of EU law. My understanding here is that conformity to a harmonized standard could be used as a presumption of conformity (and of course within the scope of annex Z) to the cited directive or regulation's Essential Requirements (ERs) or General Safety and Performance Requires (GSPRs). This appeared to cause a halt to harmonization activities for a period of time.

    As @Ludger Moeller stated, very interesting conversation!

    Lena Cordie-Bancroft
    Victoria MN
    United States