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  • 1.  RED directive over R&TTE

    Posted 30-Mar-2017 00:40

    Hi ,

     

    Does anybody have experience with Radio Equipment directive (RED) which is effective from June'16 for new products and older products from Jun'17 . According to a recent webinar, the harmonised standards for the RED directive are still in process. However it seems mandatory to claim compliance to the new directive. How does one comply with the new directive given the fact that the standards are still in process?

     

    Thanks & Regards,

     

    Rashmi Pillay

    Regulatory Affairs Associate

    Ellex Medical
    82 Gilbert Street, Adelaide SA, 5000
    T + 61 8 7074 8105
    F +61 8 8104 5231

    rpillay@ellex.com

     



  • 2.  RE: RED directive over R&TTE

    Posted 31-Mar-2017 04:24
    Hi Rashmi,

    Indeed, ETSI has been updating nearly all their radio standards in the past 12 months and some are still in process. Although the EU has been updating the standard list through monthly Official Journal publications (about 14 standards added to the list in latest OJ version dated march 10), several are still missing.

    You may refer to ETSI website - or discuss with your lab that should have monitor closely those standards evolutions - to check if the standard was already approved by ETSI or not. In the first case, they will be published to OJ in the next updates and you can start the testing and updating your technical documentation. In the later case, I'm afraid you will have to contact a Notified Body.






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    Stephane Mazet
    Qualcomm Life
    Paris, France
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