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  • 1.  EU commission implementing decision 2020/350

    Posted 23-Feb-2021 21:39
    Hi all, 

    My question is related to the EU Commission Implementing Decision 2020/350 of 28 Feb 2020 for HIV and HCV first line assays and self tests. From what I understand, this decision is in effect since 02 July 2020 and will remain till 01 March 2021. Are you aware of what to expect after 01 March 2021 i.e if this decision will continue to be in effect or if there is another decision expected on this topic? Any insights will be helpful. Thanks! 

    Tejas

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    Tejas Kulkarni

    Canada
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  • 2.  RE: EU commission implementing decision 2020/350

    Posted 25-Feb-2021 03:31
    Dear Tejas,

    this is Article 2 of COMMISSION IMPLEMENTING DECISION (EU) 2020/350:

    Article 2
    1. This Decision shall apply from 2 March 2021.

    2. Notwithstanding paragraph 1, from 2 March 2020 until 1 July 2020 Member States shall apply the presumption of compliance laid down in Article 5(3) of Directive 98/79/EC for all in vitro diagnostic medical devices that comply with any of the following:

    (a) the common technical specifications laid down in Decision 2002/364/EC as amended by Commission Decision 2011/869/EU (4);
    (b) the common technical specifications laid down in Decision 2002/364/EC as amended by Commission Implementing Decision (EU) 2019/1244 (5);
    (c) the common technical specifications laid down in Decision 2002/364/EC as amended by this Decision.

    3. Notwithstanding paragraph 1, from 2 July 2020 until 1 March 2021 Member States shall apply the presumption of compliance laid down in Article 5(3) of Directive 98/79/EC for all in vitro diagnostic medical devices that comply with either of the following:

    (a) the common technical specifications laid down in Decision 2002/364/EC as amended by Implementing Decision (EU) 2019/1244;
    (b) the common technical specifications laid down in Decision 2002/364/EC as amended by this Decision.


    There is one period from
    • 2 March 2020 until 1 July 2020
    Another period from
    • 2 July 2020 until 1 March 2021
      • The day after 1 March 2021 is the day from Article 2, 1.
        • So, without looking into the 2 a-c and 3 a-b, the COMMISSION IMPLEMENTING DECISION (EU) 2020/350 will also be applicable after 2 March 2021.

    I hope that I could help you. If not, please let me know!

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    Lukas Losigkeit
    CEO & Principal Consultant
    Hamburg
    Germany
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    Original Message


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