[{"data":1,"prerenderedAt":194},["ShallowReactive",2],{"content-prrc-en":3},{"id":4,"title":5,"body":6,"description":185,"extension":186,"meta":187,"navigation":189,"path":190,"seo":191,"stem":192,"__hash__":193},"content\u002Fprrc\u002Fprrc.en.md","Person Responsible for Regulatory Compliance (PRRC)",{"type":7,"value":8,"toc":172},"minimark",[9,13,17,20,23,40,43,47,50,67,69,73,76,78,82,85,93,95,99,102,106,109,111,115,118,121,129,132,134,138,141,149,152,154,158,161,169],[10,11,5],"h2",{"id":12},"person-responsible-for-regulatory-compliance-prrc",[14,15,16],"p",{},"Under the MDR (EU) 2017\u002F745 and IVDR (EU) 2017\u002F746, manufacturers are required to have access to a Person Responsible for Regulatory Compliance (PRRC).",[14,18,19],{},"Micro and small enterprises are not required to have a PRRC within their organization, but they must have permanent and continuous access to this function.",[14,21,22],{},"According to Commission Recommendation 2003\u002F361\u002FEC:",[24,25,26,34],"ul",{},[27,28,29,33],"li",{},[30,31,32],"strong",{},"Micro enterprises",": fewer than 10 employees and limited annual turnover or balance sheet",[27,35,36,39],{},[30,37,38],{},"Small enterprises",": fewer than 50 employees and limited annual turnover or balance sheet",[41,42],"hr",{},[10,44,46],{"id":45},"prrc-responsibilities","PRRC Responsibilities",[14,48,49],{},"The PRRC ensures that:",[24,51,52,55,58,61,64],{},[27,53,54],{},"The conformity of devices is appropriately checked in accordance with the manufacturer’s Quality Management System prior to release",[27,56,57],{},"Technical documentation and the EU Declaration of Conformity are properly prepared and kept up to date",[27,59,60],{},"Post-Market Surveillance (PMS) obligations are fulfilled",[27,62,63],{},"Regulatory reporting obligations are met",[27,65,66],{},"For investigational devices, the declaration referred to in Annex XV (MDR) and Annex XIV (IVDR) is issued",[41,68],{},[10,70,72],{"id":71},"organizational-structure","Organizational Structure",[14,74,75],{},"Multiple PRRCs may be appointed within an organization. Responsibilities can be distributed and coordinated among different PRRCs to ensure that all regulatory activities are properly managed.",[41,77],{},[10,79,81],{"id":80},"regulatory-requirements","Regulatory Requirements",[14,83,84],{},"Manufacturers and Authorized Representatives must provide the name, address, and contact details of the PRRC when:",[24,86,87,90],{},[27,88,89],{},"Registering in EUDAMED",[27,91,92],{},"Placing devices on the market",[41,94],{},[10,96,98],{"id":97},"our-services","Our Services",[14,100,101],{},"ALTRION provides qualified PRRC services, ensuring continuous regulatory oversight, compliance with MDR and IVDR requirements, and reliable support throughout the entire product lifecycle.",[10,103,105],{"id":104},"prrc-services","PRRC Services",[14,107,108],{},"ALTRION’s services as a Person Responsible for Regulatory Compliance (PRRC) are designed to be flexible, structured, and aligned with the specific needs of each manufacturer.",[41,110],{},[10,112,114],{"id":113},"custom-made","Custom-Made",[14,116,117],{},"Our PRRC services are tailored to each organization.",[14,119,120],{},"The annual fee is determined based on:",[24,122,123,126],{},[27,124,125],{},"The size of the company",[27,127,128],{},"The number of product families marketed",[14,130,131],{},"Each activity is defined in detail through a structured quotation.",[41,133],{},[10,135,137],{"id":136},"performance","Performance",[14,139,140],{},"We support:",[24,142,143,146],{},[27,144,145],{},"Post-market analysis and reporting",[27,147,148],{},"Continuous monitoring of device performance",[14,150,151],{},"The importance of performance monitoring is widely recognized, and our approach ensures that relevant data is properly collected, analyzed, and utilized.",[41,153],{},[10,155,157],{"id":156},"compliance","Compliance",[14,159,160],{},"We support manufacturers from the initial stages, including:",[24,162,163,166],{},[27,164,165],{},"Product evaluation and documentation review",[27,167,168],{},"Verification of device compliance in accordance with MDR requirements and Competent Authority expectations",[14,170,171],{},"Our goal is to ensure that all regulatory obligations are met efficiently and consistently throughout the product lifecycle.",{"title":173,"searchDepth":174,"depth":174,"links":175},"",2,[176,177,178,179,180,181,182,183,184],{"id":12,"depth":174,"text":5},{"id":45,"depth":174,"text":46},{"id":71,"depth":174,"text":72},{"id":80,"depth":174,"text":81},{"id":97,"depth":174,"text":98},{"id":104,"depth":174,"text":105},{"id":113,"depth":174,"text":114},{"id":136,"depth":174,"text":137},{"id":156,"depth":174,"text":157},"PRRC services for MDR and IVDR compliance, ensuring regulatory oversight and continuous conformity for medical devices.","md",{"image":188},"\u002Fimages\u002Fprrc.jpg",true,"\u002Fprrc\u002Fprrc.en",{"title":5,"description":185},"prrc\u002Fprrc.en","PaLctFv08wyoLd46kcJ9LlauoDR6_5pqCID3PG_00D0",1775573784294]