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  • 1.  Quality or Regulatory in the EU Regulations

    Posted 03-Jul-2017 15:08

    The EU-MDR and EU-IVDR, Article 10 requires the manufacturer to implement a Quality Management System and lists some areas the QMS needs to cover. It appears that the scope is larger than ISO 13485:2016. Some colleagues have suggested that this will blur the traditional distinction between quality and regulatory. I don't know where to the draw the line, because my background is quality, often in small companies, that may not have separated them well.

     

    The regulations, in Article 10, enumerate the minimum aspects of the QMS. I've paraphrased them below. My question is which, if any, people would consider "regulatory" and not "quality". I would also be interested on thoughts about "blurring the line".

     

    A strategy for regulatory compliance

    Addressing the applicable general safety and performance requirements (think Annex I)

    Responsibility of the management

    Resource management, including selection and control of suppliers and sub-contractors

    Risk management

    Clinical evaluation (MDR) or performance evaluation (IVDR)

    Product realization

    Implementing UDI

    Managing the post-market surveillance system

    Handling communication with competent authorities, notified bodies, other economic operators, customers, or other stakeholders

    Reporting serious incidents and field safety corrective actions

    Managing corrective and preventive actions and verifying their effectiveness

    Processes for monitoring and measuring output, data analysis, and product improvement



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    Dan O'Leary
    Swanzey NH
    United States
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  • 2.  RE: Quality or Regulatory in the EU Regulations

    Posted 05-Jul-2017 08:55

    Hello Dan,

    I also come from smaller companies where there is less traditional distinction between regulatory and quality. I would consider the following to be regulatory functions with the remainder belonging to quality:  strategy, clinical evaluation, UDI, post-market surveillance, and reporting.  Nevertheless, whether primary responsibility of quality or regulatory, all are covered by the QMS. 



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    Diane King RAC
    Redwood City CA
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    Original Message


  • 3.  RE: Quality or Regulatory in the EU Regulations

    Posted 06-Jul-2017 12:41
    ​​I have also found that the lines are more commonly blurred than not, both small and mid-sized device companies.

    There are a number of ways you can look at many of these functions.  I think that anything that is product specific is in the product manager's court, and it is only when addressing systemic/company-wide activities that one considers what to call 'X' and what to call 'Y'.  For example, a CER is product specific; the process for doing CERs is systemic (needs an SOP).  If it is something cited in your company's QS standard, then it is Quality.  Otherwise, it's probably something else, although a quality system is by no means the depth and breadth of Quality.

    In the end, I don't think what you "consider" something is particularly important.  The important thing is to know what resources, including expertise, are needed and to have them available when you need them.  If you have someone with the expertise to pull together a CER that conforms to MEDDEV 2.7.1 Rev4, call them a farmer and the activity farming, and it still is what it is.  I'd much rather have that "farmer" do my CER than a "regulatory " or "quality" professional who only knows how to grow tomatoes.

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    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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    Original Message


  • 4.  RE: Quality or Regulatory in the EU Regulations

    Posted 06-Jul-2017 14:36
    Hi Dan,

    I agree that the new standard, by pulling in more activity that was classically "Regulatory" further blurs an already blurry line. That said, I think it already was, to some extent as no matter how long I am in quality, I believe the functional "owners" own the quality and compliance of their areas. Thus, I currently run R&D, and I believe I, not the Quality or Regulatory departments, own design controls, DFMEAs and other design based risk activity etc. (and I say this having previously run RA/QA - when I believed the same thing). The role of QA is verifying that what we come up with does indeed meet the requirements in the standards/regs.

    From your list, I generally split as below, but I have seen many of these flipped....(and, in the interest of complete disclosure, at one point in my career I ran RA but staged a coup and took over much of this because our Quality department was not being at all effective at them)

    A strategy for regulatory compliance - Regulatory - though that assumes this is not "Quality Compliance" but much broader "Regulatory Compliance"

    Addressing the applicable general safety and performance requirements (think Annex I) - Regulatory & R&D

    Responsibility of the management - Executive team - as executives, we don't get to delegate this - though I would tie Quality into making sure audits and Management Reviews happen with appropriate content

    Resource management, including selection and control of suppliers and sub-contractors - Quality (though Supply Chain and HR should won large sections of this)

    Risk management - Quality (overall connectivity of assessments) - R&D/Manufacturing (FMEAs and other product level documents)

    Clinical evaluation (MDR) or performance evaluation (IVDR) - Medical/Clinical (but if not possible, RA tends to be more comfortable with this type of writing)

    Product realization - R&D/Engineering

    Implementing UDI - Quality (though I know a lot of people place in RA)

    Managing the post-market surveillance system Either - depends on where skills are in given org

    Handling communication with competent authorities, notified bodies, other economic operators, customers, or other stakeholders
    Varies - RA for regulators and preferably NBs (reg folks get hired for writing skills); customers might be legal, customer service etc. Other stakeholders depends on who - Board of Directors should be RA/QA exec or President/CEO

    Reporting serious incidents and field safety corrective actions always seen Quality Compliance but I think could fit in RA and bigger orgs often have completely separate department under Medical Affairs

    Managing corrective and preventive actions and verifying their effectiveness Quality (ones typically trained in RCA and other techniques that make CAPA work)

    Processes for monitoring and measuring output, data analysis, and product improvement Quality

    g-

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    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Maplewood MN
    United States
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    Original Message


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