Hi Grace For your point 2
Under the RE-D for EMC compliance, you are not required to use a notified body if a particular standard is not listed in the OJEU. See Articles 3(1)(b) and 17(2) of the RE-D http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32014L0053&from=EN Kind regards Kevin From: Grace Lin [mailto:graceli...@gmail.com] Sent: Monday, April 03, 2017 1:35 AM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] Active Implantable Medical Devices Dear Members, For active implantable medical devices to comply with the RED requirements: 1. Do all active implantable medical devices require Notified Body’s involvement per RED? From online search (https://ec.europa.eu/growth/single-market/ce-marking/manufacturers_en<https://urldefense.proofpoint.com/v2/url?u=https-3A__ec.europa.eu_growth_single-2Dmarket_ce-2Dmarking_manufacturers-5Fen&d=DwMFaQ&c=0YGvTs3tT-VMy8_v51yLDw&r=opngXt0GJI9CAIpmFDu4mUv_xoHzGtzX8PosGAmQ4SY&m=PpPM367w6MVG8MaOZz-CW6nLegeKiGFCMhme5b5amOc&s=TPWHe5tJnrMBRWXN9ELlsMoCHqbLg-YRimZSeaMeTYA&e=>), it seems the answer is yes. Could you please confirm? 2. The 301 489 series EMC standards covering RED have not been published/harmonized. For those manufacturers that do not want to wait for the harmonized standards to be published, should the manufacturers proceed with the DRAFT version of the standards (and send to NB)? 3. Do you have any idea when 301 489 series standards covering RED will be published? The current status is “On Approval”. Thank you very much for your time and I look forward to hearing from you. Best regards, Grace Lin - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. 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