Boudicca® DX European Union Regulatory Consulting Services
EU IVDR and EU MDR Experts Based in the EU
Accelerate EU Time-to-Trial & Time-to-Market
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BOUDICCA DX LIMITED
Ireland Companies Registration Office (CRO) Registration Number: 779741
Private Company Limited by Shares
Registered Address (Ireland Company Secretary)
6th Floor, 2 Grand Canal Square
Dublin 2, Ireland, D02 A342
Trading Address & EU Office
The Red Church, Unit 7
Henry Street, Limerick, V94 XY20, Ireland
EU Legal Representative Services
- Provide representation for EU IVDR and EU MDR clinical Performance Studies
- Consultants are EU IVDR & MDR experts qualified as Person Responsible for Regulatory Compliance (PRRC)
- Support compliance obligations for studies evaluating the scientific, analytical & clinical performance of an IVD or medical device
- Point of Contact for communications with the National Competent Authority(ies) (NCAs)
- Submit and manage NCA submission packages
- Manage NCA Requests for Information (RFIs)
- Generate high quality NCA submissions
- PhD-trained with professional IVD & MD working experience
- ASCP-certified molecular technologist to support extraction of analytical and clinical performance testing data from CLIA, CAP & NYS-CLEP assay validation reports to support EU IVD documentation
- Clinical biomarker, Companion Diagnostics (CDx), & Translational Science experience
- Drug development experience to understand the clinical trial context of use
- Advise on appropriate endpoints for Performance Studies
- Complete General Safety and Performance Requirements (GSPR) Template
- Provide integrated independent monitoring (ISO 20916)
- Streamline & harmonize EU, US & ROW global submissions to reduce costs & timelines
EU Authorised Representative Services
- Represent manufacturer placing IVDs & Medical Devices on the EU market
- Qualified Person Responsible for Regulatory Compliance (PRRC)
- Support Single Registration Number (SRD) & UDI-DI assignments
- Secure Document Storage (copy of Technical Documentation, EU declaration of conformity, etc.)
Notified Body CE-marking Support
- Product Classification Support
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- MDR Class I, Class IIa, Class IIb or Class III
- IVDR Class A, Class B, Class C or Class D
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- PhD-trained scientists with professional IVD & MD experience manage & review Technical Documentation
- Generate & review Intended Purpose statements
- Ensure performance data support the Intended Purpose
- Manage State-of-the-art (SOTA) analysis & documentation
- Experts in EU-recognized standards for IVDs & MDs
- Scientific Literature Reviews
- Generate Summary of Technical Documentation (STED)
- Generate Summary of Safety and Performance
- Generate Labeling
- Medical Writers manage & publish Technical Documentation
- Assessment of Conformity with EU IVDR & MDR procedures
- Accurate completion of General Safety and Performance Requirements (GSPR) Template
- Support EU Reference Laboratory (EURL) Performance Verifications if required
- Support distance sales manufacturers (e.g., US, UK laboratories) with compliance
- Support Structured Dialogue meetings
- Manage document translations
EU Companion Diagnostics (CDx) Expertise
- 15+ years of EU CDx experience throughout IVDD to IVDR transition
- EU Clinical Trial Support
- Review Biopharma clinical protocols <24 hr to identify if assays are subject to EU IVDR
- Experience with allcomers & biomarker-selection clinical trials in EU & regulatory expectations for both approaches
- Experience with rare and ultra-rare disease clinical trials
- Accurate completion of EU IVDR section of clinical trial application cover letters
- Describe clinical biomarker testing appropriately in Investigational Medicinal Product Dossier (IMPD) and Biopharma clinical protocols
- EU IVDR Performance Study documentation for interventional biomarker testing
- Integrated Monitoring (ISO 20916 compliance)
- Manage submissions to National Competent Authorities
- Experience with Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Portugal & Spain
- Manage Ethics Committee (EC) submissions
- Experience leveraging local comprehensive genomics profiling and genetics testing for eligibility
- Experience leveraging Article 5(5) health institution exemption status
- Support Article 5(5) In-house testing set-up & GSPR compliance
- Continuous intelligence from supporting 100+ EU clinical trials & attending EMA CHMP and National Competent Authority Scientific Advice Meetings
- Commercial CDx Support
- Support EMA CDx discussions on whether a CE-marked CDx is required for the authorised therapy
- Support CDx manufacturers with CE-marking & Notified Body submissions
- Review Technical Documentation
- Support Structured Dialogue meetings
- Support EMA consultations during conformity assessment
- Manage Requests for Information (RFIs)
- Extensive global CDx clinical bridging study experience
- Supported bridging studies in China, EU, Japan, & US for EMA, FDA, & PMDA for marketing authorisations
- Performance evaluation notifications for bridging studies with leftover samples
- Biostatistician to support ascertainment rate alignments with Notified Bodies and to provide negative sampling strategies, sensitivity analyses, imputation & missing data handling in accordance with current regulatory expectations
- EU Clinical Trial Support
Certified Experts Support Quality Compliance:
- ISO 13485 Medical Devices Quality Management System
- ISO 9001 Quality Management Systems
- ISO 20916 Clinical Performance Studies
- ISO 14971 Risk Management
- ISO 14155 Clinical investigation of medical devices for human subjects GCP
- ISO 15189 Medical Laboratories Requirements
- ISO 27001 Information security, cybersecurity and privacy protection
- ISO 42001 Artificial Intelligence Management System (AIMS)
- IEC 62304 Software Life Cycle Process
- ISO 19011 Auditing Management Systems
- Support Software Development Plans, Requirements Analysis, Architectural Design, Unit Implementation, Verification, Integration Testing, Systems Testing, Release & Risk Assessment
- AI/ML Risk Management
- Train-Test-Deploy Documentation
- AI/ML Requirements
- Verification & Validation
- Electrical safety & electromagnetic compatibility
- Mechanical & Thermal Risks
- GCP
- Implementation & Audits
- Apply Quality by Design (QbD) approach
