Feb 18, 2021 #1 K.P.M. Mechanical Jun 5, 2015 36 0 0 IN Hello , We are looking for consulting firm or person who can guide & get "CE mark" approval for our equipment as per "Medical Device Regulation (MDR 2017/745)" Please give lead. Regards, Kejul
Hello , We are looking for consulting firm or person who can guide & get "CE mark" approval for our equipment as per "Medical Device Regulation (MDR 2017/745)" Please give lead. Regards, Kejul
Mar 24, 2021 #2 The Obturator Mechanical Feb 22, 2010 621 0 16 GB You may want to see the information contained in this link. One of your requirements will be finding an acceptable Notified Body in your country. https://leonresearch.com/medical-devices-europe-mdr-2017-745/ and/or https://eumdr.com/ Or go to the EU pages from here;- https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745 Per ISO-4126, only the term Safety Valve is used regardless of application or design. Upvote 0 Downvote
You may want to see the information contained in this link. One of your requirements will be finding an acceptable Notified Body in your country. https://leonresearch.com/medical-devices-europe-mdr-2017-745/ and/or https://eumdr.com/ Or go to the EU pages from here;- https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745 Per ISO-4126, only the term Safety Valve is used regardless of application or design.