US to Europe (MDR / IVDR) Market Access Program

We help US medical device manufacturers leverage existing FDA approvals to accelerate access to UK and European markets.

  • Strategy planning and optimisation ensures the most efficient possible route to CE-marking. We provide clear steps, timelines, costs and risks tailored to your device and commercial goals.

  • Understand clinical evidence requirements from the outset with a bespoke evidence plan that maximises reuse of existing safety & performance data.

  • Leverage existing FDA approvals to save time, money and resource requirements from the EU certification pathway.

  • A complete end-to-end service: Our UK-based team handle all aspects of your submission, from planning, implementation, submission management and PMS.

Get started for free

  • Claim a free US-to-EU strategy planning session with one of our experts. No charge, no obligation, no risk.
  • We'll map out an optimised route to EU MDR / IVDR certification tailored to your device and business - completely free of charge.
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Get certified: What do we provide?

  • Gap analysis, regulatory dossier development, clinical evaluation, QMS alignment and Notified Body management. Complete support to full approval.
  • Eliminate risk: ensure EU MDR / IVDR compliance alongside alignment with the EU AI Act, GDPR, domestic laws and other relevant European regulations.
  • We can act as your Authorized Representative or PRRC, solving regulation-specific challenges otherwise difficult to overcome from outside Europe.
  • Dedicated focus on Clinical / Performance Evaluations, SSCPs, UDI-DIs and other submission components that are unique to MDR / IVDR while maximizing use of your existing FDA filings.
  • Clarity on considerations for user / patient-facing information including labelling, IFUs, marketing copy and language / translations.
  • Whether you have FDA approval through 510(k), de novo or a Pre Market Application, our FDA-to-EU program helps ensure the most efficient route into the UK and EU markets.

Ongoing support post approval

  • Stay certified and meet extensive post-approval requirements through comprehensive support covering PMS, vigilance & PMCF for all types of medical device.
  • Keep ahead of evolving EUDAMED requirements and Competent Authority market surveillance.
  • Sow the seeds for immediate sales traction post-approval through evidence-based value proposition development tailored to local stakeholders.
  • Collection of ongoing safety & performance data throughout the lifetime of your device – no need to travel to the EU / UK!
  • Perform necessary Competent Authority engagement and handle inbound market data (complaints, adverse events) without needing any native language speakers or a physical presence abroad.
  • Access a curated partner network of dedicated marketing, sales & logistics teams with ‘boots on ground’ in your target territories.

Ready to expand into Europe?

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