Regulatory Readiness & Strategy for UK/EU Market Access

The path to market in the UK and Europe has never been more complex. Post-Brexit divergence, the full implementation of the EU MDR/IVDR, and the emerging EU AI Act have created a labyrinth of new requirements for health tech innovators.

Compliance is no longer just a box-ticking exercise; it is a critical strategic pillar that defines your product's design, clinical data requirements, and go-to-market timeline. A misstep here doesn't just mean a delay—it can mean being locked out of key markets entirely. At Global MedTech, we ensure your regulatory strategy is fully aligned with your commercial goals from day one.

We don't view regulation in isolation. Our "5-Steps Framework" integrates regulatory planning into the earliest stages of market access. We help you understand:

• Which classification your product truly falls under and the implications for clinical evidence.
• How to design your clinical trials to satisfy both UK (MHRA) and EU (Notified Body) requirements simultaneously, saving time and money.
• The commercial impact of regulatory decisions on reimbursement and procurement models like the NHS.

We provide the high-level roadmap and strategic oversight to ensure your journey to market is as smooth and predictable as possible.

UK Market Access (MHRA & UKCA) 

Navigating the post-Brexit landscape is critical. We guide you through the transition to UKCA marking, the specific requirements of the MHRA, and the future regulatory framework for medical devices in Great Britain. We help you understand the specific nuances of the UK market, including the Innovative Devices Access Pathway (IDAP). 

EU Market Entry (MDR & IVDR) 

The Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) have significantly raised the bar for clinical evidence and post-market surveillance. We help you conduct gap analyses against these new standards, plan your technical documentation, and prepare for interactions with Notified Bodies. 

AI & Digital Health Regulation 

AI-driven medical devices face a double challenge: meeting standard medical device regulations plus emerging AI-specific legislation like the EU AI Act. We provide clarity on:

• Determining if your software is a Medical Device (SaMD).
• Navigating AI-specific requirements for transparency, data governance, and human oversight.
• Aligning with standards like the NHS's Digital Technology Assessment Criteria (DTAC) for UK market entry.

At Global MedTech, our focus is on the high-level regulatory strategy and its commercial implications. For the detailed, hands-on execution of that strategy, including technical file authoring, clinical evaluation report (CER) writing, and quality management system (QMS) implementation, we have a dedicated strategic partnership.
We work hand-in-glove with our sister company, Innovate Health Consulting Ltd., a specialist firm focused on the operational delivery of regulatory and quality projects. This unique structure provides you with:

• Integrated Service: A single, cohesive roadmap where strategic decisions are seamlessly translated into operational tasks.
• Specialist Expertise: Access to a deep bench of regulatory writers, quality auditors, and clinical experts dedicated to the execution phase.
• Efficiency: No need to manage multiple vendors. We coordinate the entire process.
• While we define the path, Innovate Health Consulting paves it, ensuring your technical documentation is robust, compliant, and ready for submission.

Don't let regulatory uncertainty stall your market entry. Schedule a discovery call with our team to discuss your product and determine your optimal path to approval in the UK and Europe.