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  • 1.  Compliance to State of the Art International Standards - EU MDR

    This message was posted by a user wishing to remain anonymous
    Posted 07-Apr-2022 15:10
    This message was posted by a user wishing to remain anonymous

    Dear community, 

    I would like to clarify whether EU MDR demands compliance to the State of the Art of international standards. Is there any clause of EU MDR or amendment that requires manufacturers to be compliant to the SoTA of standards (e.g. ISO 10993-1:2018, ISO 15223:2021, ISO 17764:2021) ? Is there anyway the transition period? What is the take of notified bodies on this topic?

    Thank you very much for your help, 

    Kind regards


  • 2.  RE: Compliance to State of the Art International Standards - EU MDR

    Posted 07-Apr-2022 19:56
    For practical intents and purposes, the EU MDR, and especially Notified Bodies, indeed may seem to "demand" compliance with the state of the art.  The most notable of the EU MDR's legislative elements addressing this is in Annex I(1) which requires us to "take into account" the state of the art.

    However, in pure legislative terms, there is no actual legislative basis or demand for compliance with the state of the art.  For further thought about that, be sure to check out MDCG 2021-5 for some guidance on theoretical discretions that can be applied regarding use of the state of the art versions of the standards.  Therein, it states that it is important to underline that "taking into account" is different from "compliance", due to the fact that "state of the art" is not a legally defined concept, and because it involves complex aspects that are difficult to be expressed in a single and clear definition.

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


  • 3.  RE: Compliance to State of the Art International Standards - EU MDR

    Posted 08-Apr-2022 03:52
    Hello,

    This continues to be one of those mysterious areas of the requirements in Europe - it is unfortunate when there are areas such as this the Commission or MDCG does not come out with a position statement to resolve.  If you look at the EU MDR (and EU IVDR) point 20 of the preamble, point 22, Article 8, and a couple other instances talk about standards, harmonised standards, and state of the art.  Kevin is right that the phrase "state of the art" or state of art can mean many different things depending on the context and there are references in the regulations regarding state of the art.  Such as in point 20: '... well-established practice in the field at Union and international level ...' to me means exactly state of the art.  So if there is a internationally published standard done in 2021, why would a company be following the 2011 version?  This goes back to the 1970s concerning Good Manufacturing Practices which means keeping up with industry standards.

    My recommendation is having a regulations, standards, and guidance process implemented as part of the quality management system.  Not only does this list what standards or regulations the company claims conformity, but how they does this, how this impacts current product and processes, and how confirm this so-called state of the art showing the current methods are being established and implemented.  It can be as simple as a 3 or 4 column spreadsheet or even more complex, but think about how this would be done in the company.  There are differing views of regulators and Notified Bodies on this subject, but more importantly define this within your own organisation.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: Compliance to State of the Art International Standards - EU MDR

    Posted 08-Apr-2022 04:41
    I'm in agreement with both replies so far. It is hard to argue that you have reduced risk as far as possible if you have not considered the state of the art standards, regardless of their EU harmonisation status.

    In my experience so far, the EU Notified Bodies have taken slightly different stances. Some have insisted upon conformity to the latest version of the standard as this is the state of the art standard. Some have been more relaxed and have called for a formal gap assessment between the previous and current versions of a standard if the state of the art standard has not yet been met in full (which is in part the documented evidence of the 'consideration'). But in the main, the EU Notified Bodies will still assess your Technical Documentation against the latest and greatest standard, as that is their expectation. Even if they don't say "why have you not met the 2021 version of this standard" (although they probably will, and should, ask that). And this is where Richard's point about identifying your applicable standards and monitoring their status as part of your post-market surveillance is critical. The use of applicable standards is a key component for accepting the level of risk controls and thus if you no longer meet that standard, your risk acceptability decision becomes weaker and weaker.

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    Edward Ball
    Manager, Intelligence & Innovation
    Nottingham
    United Kingdom
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    Original Message


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