ISO/TR TECHNICAL REPORT 12417-2 Second edition 2022-07 Cardiovascular implants and extracorporeal systems Vascular device-drug combination products Part 2: Local regulatory information Implants cardiovasculaires et circuits extra-corporels - Produits de combinaisonmedicament-dispositifvasculaire Partie2:Directives reglementaireslocales Reference number IS0/TR12417-2:2022(E) ISO @IS02022 IS0/TR 12417-2:2022(E) COPYRIGHT PROTECTED DOCUMENT @ISO2022 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, withoutpriorwrittenpermission.Permission can berequestedfrom eitherIso at theaddress below orIso'smemberbodyinthecountryoftherequester. ISO copyright office CP 401 · Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +4122 749 0111 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2022 - All rights reserved