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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Watch our 2 1/2 minute explainer for this service.

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.

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.

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Is your company based in the United States of America?

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Does your product currently have approval under FDA?

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Are you actively pursuing certification for these products under EU MDR / IVDR

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