{"type":"profile","id":"profile=medica2026.3076798","exhSeoId":"MVcbyJAFSIm0HW6hkarZnw","name":"EUCEREP B.V.","getInTouchEmail":"","profileAddress":{"address":["Roald Dahllaan 33"],"city":"Eindhoven","zip":"5629MC","country":"Netherlands","countryCode":"NL"},"phone":{"phone":"+31 6 85008887"},"links":[{"id":"link=gv8YkTYHTpCONZjGroO0tw","type":"link","link":"https://www.eucerep.com","parentType":"profile","order":1,"visibleInLang":["en","de"]}],"media":[],"locations":[{"areaId":"17","area":"Hall 17","stand":"B03"}],"location":"Hall 17 / B03","locationIsVirtual":false,"events":[{"key":"medica2026","label":"MEDICA 2026"}],"eventIcons":[{"label":"MEDICA 2026","src":"https://www.medica.de/vis-content/event-medica2026/all-exh/Event-0mOSbpheSRej6t2ZLcI1AA.png"}],"eventMap":"https://iahapla02.messe-duesseldorf.de/en/2dexgroundV2/medica2026/3076798.svg","areaMap":"https://iahapla02.messe-duesseldorf.de/en/3dhallV2/medica2026/17/3076798.svg","areaId":"17","premium":false,"exhIsLead":false,"logoUploadedByPubimport":false,"tags":[{"id":"tag=medica2026.1","label":"Service","icon":"md md-tag-label md-tag-label-s"}],"xtags":[],"socialMedia":[{"title":"LinkedIn","link":"https://www.linkedin.com/company/eucerep-b-v/","network":"linkedin","standardDomain":"https://www.linkedin.com/"}],"synonyms":[],"text":"<p>EUCEREP helps non-EU medical device manufacturers legally sell devices in the EU and UK markets by acting as their regulatory representative, reviewing technical compliance, managing registrations, and ensuring ongoing regulatory compliance. </p><p><br></p><p> </p><p><strong>EUCEREP B.V. Services</strong></p><p> </p><p><br></p><p><strong>1. Regulatory Representation</strong></p><ul><li>Act as EU Authorised Representative (AR) and UK Responsible Person (RP) for medical device manufacturers</li><li>Manage mandate contracts and legal compliance documentation</li></ul><p><strong>2. Technical Documentation Review</strong></p><ul><li>Verify Declaration of Conformity (DoC)</li><li>Review technical files, risk management, and post-market surveillance plans</li><li>Confirm device classification and compliance route</li></ul><p><strong>3. Device Registration</strong></p><ul><li>Register devices in EUDAMED (EU) and MHRA (UK) systems</li><li>Manage UDI/basic UDI-DI codes</li><li>Track Supplier Registration Numbers (SRN)</li></ul><p><strong>4. Labelling Verification</strong></p><ul><li>Review device labels, instructions for use, and packaging</li><li>Ensure AR/UKRP contact details are correct and compliant</li><li>Verify labeling for EU, GB, and Northern Ireland markets</li></ul><p><strong>5. Post-Market Surveillance</strong></p><ul><li>Monitor device safety and report adverse events to authorities</li><li>Track regulatory updates and changes</li><li>Manage vigilance reporting timelines</li></ul><p><strong>6. Outsourced Testing Oversight</strong></p><ul><li>Manage sterilization validation, biocompatibility testing, and microbiological testing through qualified suppliers</li><li>Ensure all testing meets ISO standards</li></ul><p><strong>7. File &#38; Records Management</strong></p><ul><li>Maintain Medical Device File (MDF) for each client</li><li>Store technical documents and compliance records for 5–10 years per regulation</li></ul><p><strong>8. Customer Support</strong></p><ul><li>Provide regulatory guidance and compliance updates to clients</li><li>Assist with regulatory change assessments and device updates</li></ul><p><br></p>","pdfs":[{"id":"paper=UtPkDlZ4RNeUI8sun3glKQ","type":"paper","title":"EUCEREP Brochure","source":"https://www.medica.de/vis-content/event-medica2026/exh-medica2026.3076798/MEDICA-2026-EUCEREP-B.V.-Paper-medica2026.3076798-yYwtKLIJS3WkYi130jiskA.pdf","parentType":"profile","fileName":"EUCEREP Brochure.pdf","order":1,"visibleInLang":["en","de"]}],"tol":[],"categories":[{"id":"prod=medica2026.04.04","label":"Regulatory, quality & market access","catalogIndex":"04.04","eventIcons":[{"key":"medica2026","small":"https://www.medica.de/vis-content/event-medica2026/all-exh/Event-SzHinHZFRDix2fwVNyP4ag.png","tiny":"https://www.medica.de/vis-content/event-medica2026/all-exh/Event-0mOSbpheSRej6t2ZLcI1AA.png","label":"MEDICA 2026"}],"productList":[{"id":"prodinfo=I1QaXrEwSVeWe2WogIAuPQ","label":"Regulatory Representation (EU/UK/USA)"},{"id":"prodinfo=gvjpxePdQcC3EXyAoFubqw","label":"Technical Documentation / File"},{"id":"prodinfo=iTqqmcbsQ6GNl0ujyCUG2w","label":"Device Registration"},{"id":"prodinfo=ZetMaAOLSHma5SeJX28iFw","label":"Labelling Verification"},{"id":"prodinfo=GczLqESITMOWZF2d29tqRA","label":"Post-Market Surveillance"},{"id":"prodinfo=hBR7FXfaRveOfkPIqQ9ycg","label":"Testing Oversight & Coordination"},{"id":"prodinfo=h0X3KNYxTXmgpaw9EhFeyg","label":"File & Records Management"}],"hierarchy":[{"id":"04","label":"Healthcare Infrastructure, Manufacturing & Quality"},{"id":"04.04","label":"Regulatory, quality & market access"}]}],"write":false,"lastModified":"2026-11-03T23:20:31Z","tagsAreEditable":false,"xtagsAreEditable":false,"isGetInTouchAllowed":false}