ISO/TR TECHNICAL REPORT 20416 First edition 2020-07 Medical devices Post-market surveillance for manufacturers Dispositifs médicaux - Surveillance apres mise sur le marché incombant aux fabricants Reference number IS0/TR 20416:2020(E) ISO @ ISO 2020 IS0/TR 20416:2020(E) COPYRIGHT PROTECTED DOCUMENT @IS02020 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may be reproduced orutilized otherwise in any form orbyany means, electronic or mechanical, including photocopying,or posting on the internet or an intranet,without prior written permission. Permission can be requested from either ISO at the address below or Iso's member body in the country ofthe requester. ISo copyright office CP 401 Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +4122 749 0111 Email: copyright@iso.org Website: www.iso.org Published in Switz.erland ii @ IS0 2020 - All rights reserved