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  • 1.  ISO 13485 2016 vs EN ISO 13485:2016

    Posted 14-Mar-2016 15:38

    Hello Everyone,

    I had a question regarding regarding the differences in ISO 13485:2016 vs EN ISO 13485:2012. I work for FDA Class I exempt IVD & Self Declared General CE IVD company. We are located in the United States and sell our products to a variety of different countries internationally.

    My questions are:

    1. Can we sell our IVD products to Europe with ISO 13485:2016 ( without the EN version)?

    2. Can we sell our products to countries that require ISO 13485 with EN ISO 13485:2012? (For example, Canada, Japan, Australia)

    Ramanjot Bhatia
    Regulatory Affairs Specialist
    San Francisco Bay Area, California
    United States

  • 2.  RE: ISO 13485 2016 vs EN ISO 13485:2016

    Posted 15-Mar-2016 05:34

    Although my expertise is much more with quality systems' approvals than with product approval, let me take a stab at your questions.  I would assume that you can do with ISO 13485:2016 the same thing that you are doing already with ISO 13485:2003.  However, I would also assume that your company must be compliant now with the IVD Directive, which basically means you must be fulfilling now the expectations of Annex ZC of the EN version in order to self-declare (unless your products are exempt from CE marking).  (By the way, you may want to look closely at the coming changes in Europe - the move to an IVD regulation.  Currently about 80% of IVDs are self-declared.  Under the IVD regulation it seems only about 20% will be self-declared and the rest must involve a Notified Body approval.  You will want to see if your products will be in the 20% lucky group.)

    With regard to the other countries you ask about, again you should find that your actions taken with ISO 13485:2003 will be the same as the ones you will need to take with ISO 13485:2016.  Each country has additional requirements beyond the basic ISO 13485, which I expect your company is already addressing.

    You may wish to contact your ISO registrar with these questions and others that may come up.  In my experience, registrars can be quite helpful.

    If I am incorrect in some detail regarding product approvals I hope someone will correct me.


    William White
    Senior Consultant
    Quality System Strategies LLC
    Elkhart IN
    United States

  • 3.  RE: ISO 13485 2016 vs EN ISO 13485:2016

    Posted 15-Mar-2016 07:32
    Dear Bathia,

    First you have time till March 2016 to be compliant with the ISO-13485:2016 requirements.
    To your questions:
    1. You do not need an EN ISO 13485:2016. You need however to be compliant with the essential requirements directive 98/79/EC and the easiest way is to do so is to fill the gaps as recommended in Annex ZC.
    2. If you are compliant with EN ISO 13485:2012 you are also compliant with ISO 13485:2003/Cor 1:2009 which is accepted by numerous countries. Be careful to also fulfill the specific country requirements, that are not detailed in the ISO document.

    Best regards,

    Patrick Manouvriez
    MP.QRA Services sprl
    rue de Sondeville 20
    B-7600 Péruwelz
    TVA/BTW/VAT BE 0502.515.230
    RPM Mons division Tournai

  • 4.  RE: ISO 13485 2016 vs EN ISO 13485:2016

    Posted 15-Mar-2016 10:41


    the following are expected to happen between March and June 2016:

    1) EN ISO 13485:2016 published

    2) EN ISO 13485:2016 gets harmonized (means published in the Official Journal of the EU)

    At this point you will be able to use both the EN ISO 13485:2012 and the EN ISO 13485:2016 to cover the relevant essential requirements directive 98/79/EC for the QMS. Note that EN ISO 13485 are unlikely to cover all the er of the directive. The remaining er shall be covered somehow else.

    3) Further in time, the EN ISO 13485:2012 will get withdrawn:

    at this point you will only be allowed to use the EN ISO 13485:2016. 


    Lorenzo Muratori
    West Sussex
    United Kingdom

  • 5.  RE: ISO 13485 2016 vs EN ISO 13485:2016

    Posted 15-Mar-2016 14:25

    At the same time that ISO13485:2016 was approved and released Europe voted and approved EN ISO 13485:2016. I don't believe it has yet been harmonized but it will be soon. You can obtain this document through suppiers of European standards such as BSI. I would carefully examine this document as you update your quality system. Be aware also that the new European Medical Device Regulation (which has yet to be finalized) will change the game and require new versions of standards potentially. 

    Edwin Bills RAC, MA
    Principal Consultant
    ELB Consulting
    Overland Park KS
    United States

  • 6.  RE: ISO 13485 2016 vs EN ISO 13485:2016

    Posted 16-Mar-2016 15:13

    I generally ask or recommend from different perspectives.

    For example, I may comment or recommend from 1). business, 2). regulatory compliance; or 3) litigation perspectives.

    I will only try to address from regulatory compliance perspectives.

    As for your Q1, even though it may be exempted from working with NB, it would depend on whether or how you claim your compliance to. If you claim compliance to EN version (in your language), but you refer to ISO 13485:2016. It is not a big deal.  BUT this raises non-compliance for adequately meeting the essential requirements per IVDD as clarified under the EN version. You need to ensure your firm still meets all ERs applicable to your products including RM and GMP requirements per se.

    As for Q2, you would need to integrate local requirements, to the extent applicable, for each country in your QM. 

    As an example, in your QM not mentioning anything about Health Canada quality system requirements per the CMDR, we can picture when a firm proudly hosts an audit performed by a registrar recognized by the Health Canada, what/how Canadian auditors might feel when they learned that? They might feel embarrassed, in fact overwhelmingly embarrassed in their mind. 

    Accordingly, all things considered from regulatory compliance perspectives, I would have to say "NO" to two of your questions unless and until you can address potential deficiency.  

    DISCLAIMER: I have used certain terms to make my comments more realistic for informational purposes only.  

    Thank you.  

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

    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.

  • 7.  RE: ISO 13485 2016 vs EN ISO 13485:2016

    Posted 16-Mar-2016 18:54


    1. Can we sell our IVD products to Europe with ISO 13485:2016 ( without the EN version)?
    Answer - If you are using 13485, for Europe you must use the EN version. From a practical point of view, there is no difference, but Europe insists on the EN version. For other standards such as Risk, EN ISO 14971 is very very different from the non-EN version.

    2. Can we sell our products to countries that require ISO 13485 with EN ISO 13485:2012? (For example, Canada, Japan, Australia).
    Answer - EN standards are only applicable to Europe, the rest of the world does not recognize them. So .. for Canada only ISO 13485 2003 works and for Europe (currently) EN ISO 13485 2012 is it. The best way to look at these is to see them as the 2 separate standards that they are.

    Suggestion … put this in your quality manual and you should be OK …

    > identify both the EN and the non-EN versions in your scope or applicability section, and add …
    > "EN ISO xxxxx contains all the requirements (and additional requirements) of ISO xxxxx, therefore using EN ISO xxxxx is deemed as meeting both standards.

    Hope this helps.



  • 8.  RE: ISO 13485 2016 vs EN ISO 13485:2016

    Posted 19-Mar-2016 18:48

    The subject of your question is “ISO 13485 2016 vs EN ISO 13485:2016” however the text of your question concerns the differences between “ISO 13485:2016 vs EN ISO 13485:2012”. I’ll offer a generic answer for “ISO 13485 2012 vs EN ISO 13485:2012” and then expand it.

    First, realize the ISO 13485:2003 is an international standard. Each country or region standards organization adopts the standard, renames it, and may object to certain parts. In the US, it is AAMI/ANSI ISO 13485:2003; in Canada, it is CAN/CSA 13485-03; and in the EU, it is EN ISO 13485:2012.

    In addition, each country regulatory agencies “recognize” the various standards. In the US, FDA does not recognize either ISO 13485:2003 or AAMI/ANSI ISO 13485:2003. In Canada, Health Canada recognizes both ISO 13485:2003 and CAN/CSA 13485-03. In the EU, only EN ISO 13485:2012 is harmonized to the directives.

    The only region that requires a specific version is Canada, where the regulations require CAN/CSA 13485-03 for most device classes. The EU expects EN ISO 13485:2012, grants special status when it is used, but does not require it. The US would not allow either the international version or the US version, since QSR is required. However, the US does not object to any of the 13485 versions as an add-on to the QMS.

    You asked (sort of) if a company could legally market an IVD in Europe with ISO 13485:2003 as opposed to EN ISO 13485:2012. The answer is NO, because ISO 13485:2003 does not satisfy the requirements of any of the device directives (MDD, AIMD, or IVDD). EN ISO 13485:2012 enumerates the shortfalls. You need to determine your conformity assessment path and review the appropriate Z annex to learn the additional requirements.

    The issues with ISO 13485:2016 and EN ISO 13485:2016 are murky.

    ISO 13485:2003 is now obsolete and replaced by ISO 13485:2016.

    The US version is AAMI/ANSI ISO 13485:2016, which the US FDA does not (and never will) recognize.

    I’m not sure about Canada today, but there is a plan to end the current CMDCAS system in favor MDSAP certificates that will be synchronized with the transition to ISO 13485:2016 QMS certificates.

    In the EU, the standards body, CEN, issued EN ISO 13485:2016, but it is not (yet) a harmonized standard.

    Because the EN versions of both standards are more restrictive than the international versions, if you implement the EN versions you would be in compliance with the international versions.

    Dan O'Leary
    Swanzey NH
    United States