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  • 1.  Data protection under directive 95/46/EC and regulation (EC) No 45/2001

    This message was posted by a user wishing to remain anonymous
    Posted 02-Feb-2023 09:49
    This message was posted by a user wishing to remain anonymous

    Hello all, 

    Does IVD medical devices company need to comply with 95/46/EC & regulations No 45/2001? If yes, could you please explain the reasons as i am completely new to this. 

    Thanks.


  • 2.  RE: Data protection under directive 95/46/EC and regulation (EC) No 45/2001

    Posted 03-Feb-2023 04:44
    Edited by Richard Vincins 03-Feb-2023 04:44
    Hello Anon,

    First, this Directive was replaced with the General Data Protection Regulation (GDPR) Regulation (EC) No 1882/2003 so 95/46/EC was repealed back in 2018.  Depending on how the IVD medical device handles patient data or patient results, this may be applicable.  In some cases, patient information is kept on an instrument software and would need to determine how this would be applied and how the patient information is shared or transmitted.  The application of GDPR is sometimes quite difficult as not fully understood and how should be applied.  The first step would be to determine if GDPR is applicable, and then figure out how it would be applied to the device/software.

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


  • 3.  RE: Data protection under directive 95/46/EC and regulation (EC) No 45/2001

    Posted 06-Feb-2023 04:03
    Hello,

    If the company is based outside EU but has employees in EU or sells the product directly to costumers than it will be applicable. If you are still not sure there are plenty of companies who can prepare analysis for you if you need it and help you to be compliant to data protection regulations. 

    Have a good week.
    Olga

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    Olga Peycheva
    Regulatory and Study Start Up Specialist
    Solutions OP Ltd
    olga.peycheva@solutionsop.co.uk
    United Kingdom
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    Original Message


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