Regulatory Open Forum

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  • 1.  Disposal of clinical products

    This message was posted by a user wishing to remain anonymous
    Posted 29-Nov-2022 08:41
    This message was posted by a user wishing to remain anonymous

    Dear reg specialists, 

    I am seeking your advice on the following. 

    Are there any environmental requirements that IVDs manufacturer needs to be aware of for the disposal of clinical products?


    Thanks, Asma



  • 2.  RE: Disposal of clinical products

    Posted 30-Nov-2022 01:02
    Hello,

    This is highly dependent on local regulatory requirements and disposal of biohazardous material.  Generally, most countries or local authorities have requirements for identification, removal, disposal, and destruction of used clinical products - this is assuming there is biohazardous material, e.g. human specimens or human material.  Often the entire package or kit is disposed of as biohazardous waste, but there can components or parts of a kit which may be allowed regular disposal.  These days with recycling and minimal packaging, it is also important and sometimes clearly identified within the packaging or kit materials which can be recycled, which are for regular disposal, and which are for biohazard disposal.  For used clinical products there are often statements used such as "Dispose of biohazardous material according to local regulations" or similar, again because this can vary slightly depending on the region.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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  • 3.  RE: Disposal of clinical products

    Posted 30-Nov-2022 02:17

    Good morning, 
    and keep in mind that at least in the EU in addition to your sectoral legislation, horizontal legislation like the packaging and packaging waste directive or the REACH and CLP regulation may apply. 



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    Anna-Sophie Geiersberger
    Unterschleissheim
    Germany
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