Feb 18, 2021 #1 K.P.M. Mechanical Joined Jun 5, 2015 Messages 38 Location 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 Joined Feb 22, 2010 Messages 667 Location 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.