Boudicca® DX Limited is a registered Irish private company (Companies Registration Office Number: 779741) providing on-the-ground EU regulatory expertise for IVD and medical device manufacturers navigating IVDR and MDR. With a physical presence in Ireland, direct relationships with National Competent Authorities, and PhD-trained consultants steeped in EU IVDR and MDR Regulatory knowledge, we remove the complexity and cost of EU market access — and integrate seamlessly with your US regulatory strategy to harmonize timelines and protect your cash runway.
Accelerate EU Time-to-Trial & Time-to-Market
EU Team
Our Ireland-based team combines regulatory, scientific, and commercial expertise built specifically for the IVDR and MDR environment. PRRC-qualified consultants hold active credentials recognized under EU regulations and maintain direct working relationships with National Competent Authorities across multiple EU member states. Supported by Boudicca® DX’s global network of PhD scientists, biostatisticians, pathologists, certified regulatory experts, and molecular technologists, the EU practice delivers the depth of a large regulatory organization with the agility and accountability of a dedicated partner.
Seb Clerkin, PhD, RAC (EU)
Lead EU IVDR and MDR Consultant Based in Ireland
Seb is based in Ireland and works closely with the CEO to harmonize regulatory submissions across EU and US geographies, supporting clients in achieving successful market access for IVDs and medical devices across the EU. Seb provides expertise in the planning, execution, and oversight of clinical investigations in compliance with EU MDR and ISO 14155. Implements Quality Management Systems per EU MDR, IVDR and QMSR. Establishes EU based Authorized Representative structures for non-EU manufacturers, in line with MDR/IVDR Article 11 and Article 15 requirements. Seb has worked in EU regulatory consulting for over 15 years and clients include Stryker, DePuy Synthes, Biomarin, Teleflex, Boston Scientific, Gilead Sciences and Cook Medical.
- Regulatory Affairs Certificate (EU)
- PhD in Toxicology from the University of Bristol
- BSc. (Hons) Biochemistry from University College Dublin
Need EU IVDR or MDR Support? → courtney@boudiccadx.com
AI-Assisted EU Regulatory Intelligence — Always Current, Always Expert-Reviewed
Static regulatory navigation tools reflect the last time someone updated them. Boudicca® DX uses AI-assisted regulatory intelligence — powered by Claude (Anthropic) and reviewed by PRRC-qualified EU experts — to continuously synthesize the latest available MDCG guidance, Notified Body expectations, EMA CDx precedents, and NCA requirements across member states. Dynamic, expert-reviewed, and always current. That is the difference between a database and a strategic partner.
EU Legal Representative
Provide EU legal representation services for IVDR and MDR clinical performance studies — serving as the direct point of contact with National Competent Authorities (NCAs), managing submission packages, and handling Requests for Information (RFIs) applying our continuous regulatory intelligence from 50+ EU performance study submissions with Biopharma, IVD, medical device, and clinical laboratory clients.
Performance study submissions are prepared by PhD-trained professionals with decades of EU and US analytical and clinical performance experience, supported by on-demand biostatisticians, molecular technologists and pathologists who transform US laboratory validation data (CLIA, CAP, NYS-CLEP) into EU IVDR compliant documentation. We complete GSPR templates, advise on appropriate performance study endpoints and acceptance criteria using relevant CLSI, ICH, and ISO guidelines, support ISO 20916 compliance (monitoring, etc.), and apply a least-burdensome approach to mitigate clinical study delays and costs. Where possible, EU, US, and rest-of-world submissions are streamlined and harmonized to reduce timelines and preserve cash client runway.
Want to learn more ? → courtney@boudiccadx.com
EU Authorized Representative
Ireland-based PRRC-qualified consultants represent manufacturers placing IVDs and medical devices on the EU market, with all PRRC credentials on file in the Boudicca® DX Quality Management System. As your EU Authorized Representative, we serve as the registered point of contact with National Competent Authorities and bear the regulatory responsibilities assigned to manufacturers under IVDR and MDR — including post-market surveillance obligations, serious incident reporting, and field safety corrective action coordination. Services include Single Registration Number (SRN) and UDI-DI assignments, EUDAMED registration support, secure storage of technical documentation and EU declarations of conformity, and ongoing regulatory intelligence to ensure your product remains compliant as requirements evolve.
Want to learn more ? → courtney@boudiccadx.com
Notified Body CE-marking
Product classification support across all MDR and IVDR classes (MDR Class I–III, IVDR Class A–D), with PhD-trained professionals managing and reviewing full Technical Documentation — including intended purpose statements, AI-assisted state-of-the-art (SOTA) analysis, scientific literature reviews, GSPR completion, Summary of Technical Documentation (STED), Summary of Safety and Performance, and labeling. On-demand anatomic, clinical, and molecular pathology input is available alongside medical writing consultants for high-quality clinical and technical documentation.
Additional support covers EU Reference Laboratory performance verifications, distance sales manufacturer compliance for US, UK, and other laboratories, structured dialogue meetings with notified bodies, notified body selection and contracting, and document translations. For manufacturers transitioning from legacy IVDD certificates, we provide gap assessments and remediation roadmaps tailored to your device class, intended purpose, and notified body’s specific expectations — minimizing RFIs and keeping your CE-marking timeline on track.
Want to learn more ? → courtney@boudiccadx.com
Clinical Laboratory Compliance with Article 5(5) & Access to Our Preferred In-house Network
EU IVDR Article 5(5) permits in-house IVD manufacturing by health institutions under specific conditions — but compliance obligations are substantial and frequently underestimated. Our molecular technologists, clinical laboratory scientists, regulatory experts, and pathologists support EU laboratories in establishing and maintaining Article 5(5)-compliant in-house testing programs, including GSPR completion, quality management system alignment to ISO 15189, justification documentation demonstrating that no equivalent CE-marked device is available on the market, and analytical and clinical performance evaluations. Our consultants advise on labeling and traceability requirements, conduct gap assessments against National Competent Authority expectations, and support laboratories preparing for competent authority oversight.
For laboratories engaged in CDx or biomarker-driven clinical trials, we integrate Article 5(5) compliance directly into the broader clinical and regulatory strategy to minimize duplication, reduce timelines, and preserve institutional resources. We have successfully utilized in-house testing (AAV nAb and tAb assays, HLA testing, Immunohistochemistry [IHC], In Situ Hybridization [ISH], NGS-based tumor profiling testing, PCR-based genotyping tests, and Standard of Care Diagnostic Assays) for 100+ biomarker-driven studies over the past 3+ years cutting FPI by at least 50% and saving hundreds of thousands from not submitting unnecessary performance studies.
We have a network of preferred Article 5(5)-compliant in-house testing providers that we have worked with for 3+ years who are available to our clients to reduce selection and vendor qualification timelines. We believe in decentralized testing where our clients can work with multiple expert testing providers rather than sub-optimal central testing providers.
Want to learn more ? → courtney@boudiccadx.com
EU Companion Diagnostics
Fifteen-plus years of CDx expertise spanning the IVDD-to-IVDR transition, with deep experience in both prospective and retrospective (bridging) CDx development and EMA alignment on CE-marking requirements for authorised therapies.
We have reviewed 200+ biopharma clinical protocols to determine IVDR applicability, provided recommended biomarker testing language, supported ICF reviews, sample banking strategies, and NCA submission and Ethics Committee management — all with a focus on reducing RFIs, costs, and timeline delays.
PhD-trained scientists with hands-on drug development experience advise on all-comers and biomarker-selected clinical trial designs, cut-off selection rationale, rare and ultra-rare disease trials (including AAV gene therapies), IMPD and Investigator’s Brochure content, CTR cover letter completion, Article 5(5) in-house testing set-up and GSPR compliance when in-house testing is utilized, and contemporaneous performance study applications when needed.
Continuous regulatory intelligence is drawn from 200+ EU clinical trials and direct participation in Biopharma EMA CHMP and NCA Scientific Advice Meetings as well as generating and reviewing content for EMA MAA submissions. Support CDx manufacturer Notified Body submissions including Technical Documentation review, structured dialogue, EMA consultations, and RFI management is a CE-marked CDx is required.
Quality management & compliance
Certified and qualified consultants support compliance across the full quality and regulatory standards landscape needed for CE-marking— ISO 13485, ISO 9001, ISO 14971, ISO 14155, ISO 15189, ISO 20916, ISO 27001, ISO 42001, IEC 62304, and ISO 19011. Software and AI/ML support covers development plans, requirements analysis, architectural design, verification and validation, train-test-deploy documentation, and AI/ML risk management. Additional services include electrical safety and electromagnetic compatibility, mechanical and thermal risk assessment, GCP implementation and audits, and a Quality by Design (QbD) approach throughout. Consultants are experienced working with early-stage and resource-constrained startups who need a fit-for-purpose QMS approach.
Dublin Office (Company Secretary)
6th Floor, 2 Grand Canal Square
Dublin 2, Ireland, D02 A342
Limerick Office (Operations)
The Red Church, Unit 7
Henry Street, Limerick, V94 XY20, Ireland
Ready to accelerate your EU market access?
Whether you’re preparing your first IVDR submission, navigating a notified body audit, or harmonizing a global regulatory strategy, Boudicca® DX Limited is ready to deploy. Book a complimentary 30-minute call to discuss your program.
