Quality & Regulatory Affairs Services for EU & UK Market Access
End-to-end regulatory support for medical device, IVD, and pharma companies entering the European and UK markets. From quality system implementation to technical documentation, Notified Body submissions, and post-market compliance.
Your Regulatory Partner from First Assessment to Market
Bringing a medical device or in-vitro diagnostic to the European market is one of the most demanding regulatory journeys in the world. The EU MDR and IVDR frameworks impose rigorous requirements on clinical evidence, technical documentation, quality systems, and post-market surveillance, and the penalties for non-compliance are significant: delayed market entry, rejected submissions, or loss of certification.
MDx CRO exists to remove that burden from your team.
Our Quality & Regulatory Affairs division supports medical device manufacturers, IVD companies, pharmaceutical companies, and independent laboratories across the globe that need to achieve and maintain compliance with EU and UK regulatory frameworks. Whether you are launching a new product, managing an IVDR transition, or responding to a Notified Body query, our team of 50 in-house regulatory and quality experts delivers the strategic guidance and hands-on execution you need to move forward with confidence.
Whats set MDx apart is the depth and breadth of our expertise under one roof. We are a specialist CRO and regulatory partner whose professionals include former Notified Body auditors, ex-regulatory authority reviewers, clinical scientists, quality managers, and medical writers, all working together on your project. This integrated model means we can manage the complete product lifecycle, from clinical evidence generation and analytical validation to technical documentation, quality system audits, and regulatory submissions, without the delays or coordination gaps that come from working with multiple vendors.
Since 2022, our team has grown more than 200%. That growth reflects the trust our clients place in us and the increasing complexity of the regulatory landscape we help them navigate. Since 2022, our team has grown from 3 to 50 experts. That growth reflects the trust our clients place in us and the increasing complexity of the regulatory landscape we help them navigate.
OUR Q&RA SERVICES
A Complete Quality and Regulatory Affairs Service Portfolio
Quality and regulatory compliance does not happen in isolation. Technical documentation depends on clinical evidence. Quality system audits reveal gaps that require regulatory strategy. Scientific validity reports underpin your IVDR submission. That is why MDx offers an integrated portfolio of services that cover every dimension of Q&RA, so you always have the right expert at the right stage of your project.
MDR and IVDR-compliant technical files, Notified Body submissions, regulatory strategy, CER, PMCF, and global market submissions.
ISO 13485 QMS implementation, ISO 14971 risk management, gap assessments, internal audits, mock Notified Body audits, and CAPA support.
State-of-the-art literature reviews, scientific validity documentation, and analytical performance evidence for IVDR Annex I and technical documentation submissions.
EU Authorised Representative (EU AR) and UK Responsible Person (UKRP) services for non-EU and non-UK manufacturers. We act as your legal point of contact with competent authorities, EUDAMED registration, and post-market surveillance coordination.
Practical regulatory training for in-house teams, including MDR/IVDR fundamentals, technical documentation workshops, and audit readiness programmes. Delivered by the same experts who train European Notified Body assessors.
FAQ
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What is the difference between EU MDR and EU IVDR?
EU MDR (Regulation 2017/745) governs medical devices, while EU IVDR (Regulation 2017/746) applies specifically to in-vitro diagnostic medical devices. Both replace older directives (MDD and IVDD respectively) and impose significantly more rigorous requirements for clinical evidence, technical documentation, quality systems, and post-market surveillance. IVDR introduces a new risk-based classification system for IVDs, with the majority of previously self-certified products now requiring Notified Body involvement. MDx provides specialist support under both regulations.
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Do I need an EU Authorised Representative if my company is based outside Europe?
Yes. Any manufacturer located outside the European Union that places a medical device or IVD on the EU market must appoint an EU Authorised Representative (EU AR). The EU AR is legally registered in the EU, listed in EUDAMED, and serves as the official point of contact with competent authorities. MDx provides EU AR services as part of our Representative Services offering.
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What does an ISO 13485 gap assessment involve?
An ISO 13485 gap assessment compares your existing quality management system against the requirements of the ISO 13485:2016 standard. MDx evaluates your current procedures, documentation, training records, and processes, then produces a detailed report identifying non-conformities, areas of partial compliance, and recommended corrective actions. The output gives you a clear, prioritised roadmap for achieving certification.
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How long does IVDR technical documentation take to prepare?
Timelines depend on the classification of your IVD, the maturity of your existing documentation, and the availability of performance data. For Class C or Class D IVDs, complete technical documentation remediation typically takes between four and ten months. MDx conducts a detailed assessment at project initiation to provide a precise timeline for your specific product and situation.
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Can MDx support both our quality system and our regulatory submissions in the same project?
Yes. MDx provides integrated support across quality management, risk management, and regulatory affairs within a single coordinated project. This is one of our key differentiators — the same team understands both the quality system underpinning your product and the regulatory pathway you are pursuing, which improves consistency and reduces overall project timelines.
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We are a US-based company with no EU presence. Can MDx manage the entire EU market access process for us?
This is one of the most common engagements for our team. MDx can act as your EU Authorised Representative, manage EUDAMED registration, prepare or remediate your technical documentation, implement or align your quality management system, and coordinate directly with Notified Bodies on your behalf. Many of our US and APAC clients describe this as having a fully functional EU regulatory team without needing to hire one internally.
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What is MDCG 2020-13 and why does it matter for our technical file?
MDCG 2020-13 is a guidance document published by the Medical Device Coordination Group that defines how manufacturers should conduct clinical evaluations for legacy devices transitioning from MDD to MDR. It provides specific methodology for demonstrating equivalence and contextualising the state of the art. For many legacy device manufacturers, MDCG 2020-13 is one of the most consequential documents in their MDR compliance programme, and non-compliance with its methodology is a frequent cause of Notified Body queries and rejections.
Related Resources about Quality and Regulatory Affairs
Your Next Market Is Within Reach.
Whether you are starting a new market access programme, managing an IVDR or MDR transition, or looking to strengthen your quality management system ahead of a Notified Body audit, MDx has the team and the expertise to get you there. The EU and UK regulatory pathway is complex, but with the right partner, it is entirely manageable. We placed 500+ devices on the European market. Yours can be next.
