[{"data":1,"prerenderedAt":142},["ShallowReactive",2],{"content-ce-marking-en":3},{"id":4,"title":5,"body":6,"description":134,"extension":135,"meta":136,"navigation":137,"path":138,"seo":139,"stem":140,"__hash__":141},"content\u002Fce-marking\u002Fce-marking.en.md","CE Marking for European Market",{"type":7,"value":8,"toc":118},"minimark",[9,14,18,21,24,28,33,40,44,49,53,58,62,67,71,79,83,88,92,100,104],[10,11,13],"h2",{"id":12},"ce-marking-for-the-european-union","CE Marking for the European Union",[15,16,17],"p",{},"To place a medical device on the European Union market, manufacturers must comply with the EU Regulation (EU) 2017\u002F745 (MDR) or 2017\u002F746 (IVDR).",[15,19,20],{},"ALTRION provides end-to-end support for CE marking, from Technical Documentation preparation to Notified Body coordination and Post-Market Surveillance (PMS) management.",[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",{},"Determination of device classification (Class I, Is, Im, IIa, IIb, III)",[29,41,43],{"id":42},"technical-documentation","Technical Documentation",[34,45,46],{},[37,47,48],{},"Preparation and structuring of the Technical Documentation (Annex II & III)",[29,50,52],{"id":51},"clinical-evaluation","Clinical Evaluation",[34,54,55],{},[37,56,57],{},"Clinical Evaluation Plan (CEP) and Report (CER) drafting in compliance with MDCG guidance",[29,59,61],{"id":60},"risk-management","Risk Management",[34,63,64],{},[37,65,66],{},"Risk Management File in accordance with ISO 14971:2019",[29,68,70],{"id":69},"usability-software-compliance","Usability & Software Compliance",[34,72,73,76],{},[37,74,75],{},"Usability Engineering (IEC 62366-1)",[37,77,78],{},"Software Life-Cycle documentation (IEC 62304)",[29,80,82],{"id":81},"conformity-assessment","Conformity Assessment",[34,84,85],{},[37,86,87],{},"Coordination with Notified Bodies for conformity assessment procedures (Annex IX, X, XI)",[29,89,91],{"id":90},"regulatory-representation","Regulatory Representation",[34,93,94,97],{},[37,95,96],{},"Preparation of Declaration of Conformity",[37,98,99],{},"EU Representative (EU-REP) designation",[29,101,103],{"id":102},"post-market-activities","Post-Market Activities",[34,105,106,109,112,115],{},[37,107,108],{},"PMS Plan",[37,110,111],{},"PSUR",[37,113,114],{},"PMCF",[37,116,117],{},"Vigilance",{"title":119,"searchDepth":120,"depth":120,"links":121},"",2,[122,123],{"id":12,"depth":120,"text":13},{"id":26,"depth":120,"text":27,"children":124},[125,127,128,129,130,131,132,133],{"id":31,"depth":126,"text":32},3,{"id":42,"depth":126,"text":43},{"id":51,"depth":126,"text":52},{"id":60,"depth":126,"text":61},{"id":69,"depth":126,"text":70},{"id":81,"depth":126,"text":82},{"id":90,"depth":126,"text":91},{"id":102,"depth":126,"text":103},"End-to-end support for CE marking under MDR and IVDR for medical devices entering the European Union.","md",{},true,"\u002Fce-marking\u002Fce-marking.en",{"title":5,"description":134},"ce-marking\u002Fce-marking.en","jFGuV41rSWLQkcKL1XBDkIG9AiLwRhhdDfr96twhJuM",1775573784294]