[{"data":1,"prerenderedAt":121},["ShallowReactive",2],{"content-ukca-marking-en":3},{"id":4,"title":5,"body":6,"description":112,"extension":113,"meta":114,"navigation":116,"path":117,"seo":118,"stem":119,"__hash__":120},"content\u002Fukca-marking\u002Fukca-marking.en.md","UKCA Marking for Medical Devices and IVDs",{"type":7,"value":8,"toc":97},"minimark",[9,14,18,21,24,28,33,40,44,49,53,58,62,67,71,76,80,85,89],[10,11,13],"h2",{"id":12},"ukca-marking-for-great-britain","UKCA Marking for Great Britain",[15,16,17],"p",{},"Following Brexit, medical devices must comply with UK MDR 2002 (as amended) and display the UKCA mark to be marketed in Great Britain (England, Scotland, Wales).",[15,19,20],{},"ALTRION, through its UK Responsible Person (UKRP) office, provides complete regulatory representation and documentation services for UKCA compliance.",[22,23],"hr",{},[10,25,27],{"id":26},"our-services","Our Services",[29,30,32],"h3",{"id":31},"regulatory-classification","Regulatory Classification",[34,35,36],"ul",{},[37,38,39],"li",{},"Device classification and conformity route identification under UK MDR 2002",[29,41,43],{"id":42},"technical-documentation","Technical Documentation",[34,45,46],{},[37,47,48],{},"Preparation of UK Technical File aligned with MHRA requirements",[29,50,52],{"id":51},"labeling-documentation-review","Labeling & Documentation Review",[34,54,55],{},[37,56,57],{},"Review of labeling, IFU, and product claims (in English)",[29,59,61],{"id":60},"uk-responsible-person-ukrp","UK Responsible Person (UKRP)",[34,63,64],{},[37,65,66],{},"Appointment and registration of UK Responsible Person",[29,68,70],{"id":69},"mhra-registration","MHRA Registration",[34,72,73],{},[37,74,75],{},"MHRA database registration and device listing",[29,77,79],{"id":78},"conformity-assessment","Conformity Assessment",[34,81,82],{},[37,83,84],{},"Liaison with UK Approved Bodies (where applicable)",[29,86,88],{"id":87},"post-market-activities","Post-Market Activities",[34,90,91,94],{},[37,92,93],{},"Vigilance, PMS, and communication with MHRA",[37,95,96],{},"Periodic updates and renewals according to MHRA guidance",{"title":98,"searchDepth":99,"depth":99,"links":100},"",2,[101,102],{"id":12,"depth":99,"text":13},{"id":26,"depth":99,"text":27,"children":103},[104,106,107,108,109,110,111],{"id":31,"depth":105,"text":32},3,{"id":42,"depth":105,"text":43},{"id":51,"depth":105,"text":52},{"id":60,"depth":105,"text":61},{"id":69,"depth":105,"text":70},{"id":78,"depth":105,"text":79},{"id":87,"depth":105,"text":88},"Full support for UKCA marking and compliance under UK MDR 2002 for medical devices entering the UK market.","md",{"image":115},"\u002Fimages\u002Fukca.jpg",true,"\u002Fukca-marking\u002Fukca-marking.en",{"title":5,"description":112},"ukca-marking\u002Fukca-marking.en","EjUCCpweMt5O3WM8eWESDoMSEGkgQFxhuDCN176tYZA",1775573784294]