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  • 1.  EU guideline for variation applicable to Medical devices

    Posted 24-Jun-2016 07:47
    Hi everyone,

    Can anyone share EU variations guidelines/regulations applicable for medical devices? EU variations guideline No. 1234/2008 only list 4 variations for medical devices and therefore cannot be considered as comprehensive.

    Regards
    Ankur




  • 2.  RE: EU guideline for variation applicable to Medical devices

    Posted 24-Jun-2016 09:37
    Hi Ankur,

    The referenced EU regulation relates to medicinal products.  

    May I ask what made you think that there would be variations available for devices within the meaning and scope of the EU regulation cited?

    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.



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  • 3.  RE: EU guideline for variation applicable to Medical devices

    Posted 25-Jun-2016 08:22

    Hi David,

    Section IV of this EU regulation (pg 88 to 90) list the variations specifically for Medical devices

    ------------------------------
    Regards
    Ankur Agarwal RAC
    India

    Original Message


  • 4.  RE: EU guideline for variation applicable to Medical devices

    Posted 27-Jun-2016 09:36

    Hallo Ankur,

    Are we talking about the same regulation? My version of EU regulation 1234/2008 is 18 pages long.

    Kind regards

    René

    ------------------------------
    Rene Becker
    Regulatory Affairs and Quality Management Consultant
    LEMAN LIFESCIENCE
    Switzerland

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  • 5.  RE: EU guideline for variation applicable to Medical devices

    Posted 28-Jun-2016 01:28

    Hi Rene,

    Sorry for this confusion. Actually I was referring to guidelines of EU regulation 1234/2008.

    Regards

    Ankur

    ------------------------------
    Ankur Agarwal RAC
    India

    Original Message


  • 6.  RE: EU guideline for variation applicable to Medical devices

    Posted 27-Jun-2016 09:43
    Greetings, Ankur,

    You may have been reading Guidelines in 114 pages not EU regulation (variations regulation).

    As for variations that you referred to, it is for medicinal products having a device whether it is an integrated part of the primary packaging or not.  The said products are those under Directives 2001/82, 2001/83, Regulation 726/2004 or Regulation 1934/2007, etc.

    For changes in those devices, it falls under variation types (IA, IV, II, etc.)

    For medical devices under Directive 93/42/EEC, there are no formal variation types per se.  Changes to the approved design must receive further approval from NB....wherever the changes could affect conformity with the essential requirements.... MDD Article 4, Para. 4.4.

    D




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  • 7.  RE: EU guideline for variation applicable to Medical devices

    Posted 28-Jun-2016 01:47

    Hi David,

    Thanks for your response. I just wanted to double check if there are any guidelines for submission of variations for medical devices (i.e. products regulated by 93/42/eec) as we have for pharmaceutical products and from your response it is clear that no guidelines exist as such. That means it is totally upon applicant's discretion to evaluate if the particular change is substantial and should be notified to NB or not. Moroever it is the applicant who determine what technical documents should go into these variation dossiers.

    But are these notification 'do and tell' or 'Tell and do' type? Is there any application form that we need to include in variation package for medical devices?

    Regards

    Ankur

    ------------------------------
    Ankur Agarwal RAC
    India

    Original Message


  • 8.  RE: EU guideline for variation applicable to Medical devices

    Posted 28-Jun-2016 08:47
    Dear Ankur,

    "Are these notification 'do and tell' or 'Tell and do' type? Is there any application form that we need to include in variation package for medical devices?"

    My high level comments are as follows.

    "Do and Tell"

    Very minor (cosmetic) changes. When in doubt, you may communicate with the NB.

    "Tell and Do"

    Changes (design or manufacturing process, etc.) that can affect the safety or the device performance.

    As for application forms, there are no formal application forms in the EU that you can download and use. But the TGA has it.

    I would recommend you have a chance to look at the STED from IMDRF.

    The notified body can give you their form (e.g., Conformity Assessment Application). You may ask your NB, if you have one.

    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.



    Original Message


  • 9.  RE: EU guideline for variation applicable to Medical devices

    Posted 29-Jun-2016 12:41

    Dear Ankur,

     

    The below documents may be what you are looking for:

     

    Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System

    http://www.nbog.eu/resources/NBOG_BPG_2014_3.pdf

     

    Recommendation NB-MED/2.5.2/Rec2: Reporting of design changes and changes of the quality system

    http://www.team-nb.org//wp-content/uploads/2015/05/nbmeddocuments/Approved_NB-MED_2_5_2_rec_2_november_2008.pdf

     

    Kind regards,

    Martina




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  • 10.  RE: EU guideline for variation applicable to Medical devices

    Posted 24-Jun-2016 14:25

    You may be looking for The Manual On Borderline And Classification In The Community Regulatory Framework For Medical Devices

    The manual is available from http://ec.europa.eu/growth/sectors/medical-devices/specific-areas-development/index_en.htm#borderline

    ------------------------------
    Dan O'Leary
    Swanzey NH
    United States

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