Boudicca DX Limited

EU Representation for In Vitro Diagnostics (IVDs) & Medical Devices

• EU local liaison providing timely communication and proactive responses to EU regulatory authorities
• Appointed Authorized Representative with legal use of EU address as a point of contact to fulfill EU legal representation requirements
• Lead Structured Dialogue Meetings with EU Notified Bodies (application process, assessment procedures, QMS requirements, conformity approaches, technical and regulatory approaches, etc.)

EU Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) Compliance 

• Dedicated regulatory experts who simplify complex EU standards
• Fit-for-purpose EU regulatory support
• Review and Manage Technical Files using PhD-trained scientists experienced in analytical & clinical validation
• Verification of Declaration of Conformity
• General Safety and Performance Requirements (GSPR) Compliance
• Support Pharmaceutical companies with clinical trial assay requirements
• Support EU IVDR clinical performance studies (Annex XIII & XIV documentation)
• Support clinical laboratories with health institution exemption Article 5(5) status compliance
• Regulatory intelligence from supporting many EU clinical trials & attending numerous Scientific Advice Meetings
• Support EMA Companion Diagnostic discussions
• Secure Document Storage
• Postmarket Surveillance Support to monitor product safety & recall assistance
• Harmonized quality & regulatory support working hand in hand with the US-based team
• ISO 13485 for Medical Devices Quality Management System
• ISO 14971 Risk Management
• ISO 15189 Medical laboratories Requirements for quality and competence

End-to-End Solution

• Support registration to labeling in the EU
• Support global harmonization working in tandem with US Regulatory Team to leverage all existing clinical & technical documentation to the maximum extent
• Save time & money with elimination of additional third parties to support EU & US regulatory submissions