US to Europe Market Access Program

Leverage your existing FDA approvals to accelerate access to UK and European markets

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

Everything you need for EU certification

We provide a complete end-to-end service — from regulatory strategy and clinical evidence planning through to Notified Body submission and post-approval support.

Complete the form to see if you qualify for our program:

Is your company based in the US?
Is your device FDA 510(k) approved?

We respect your information — Read what this means

  • Strategy planning and optimisation

    We'll ensure the most efficient possible route to CE-marking - providing clear steps, timelines, costs & risks tailored to your device and commercial goals.

  • Understand clinical evidence requirements

    We'll create a bespoke evidence plan that maximises reuse of existing safety & performance data from the outset.

  • Leverage existing FDA approvals

    We know how to use your existing FDA 510(k) to save time, money and resource requirements from the MDR / IVDR pathway.

  • Your dedicated team, start-to-finish

    Our UK-based team handle all aspects of your submission, from planning, implementation, submission management and PMS.

What Our Clients Say

  • Not only were Mantra Systems very easy to work with, but their clinical knowledge and dedication to helping us meet the tight timelines for response was top notch.

    Courtney Regulatory Affairs Manager Northgate Technologies

  • We sought help from Mantra Systems with Clinical Evaluation prior to our MDR application. Their deep understanding and experience resulted in full acceptance by our Notified Body.

    Ian Maclean Director of Engineering Koven Technology, Inc.

Your Questions Answered

  1. The service covers all key aspects of creating and managing a submission under EU MDR / IVDR. Specific elements include FDA/MDR gap analysis, regulatory dossier / technical file development, clinical / performance evaluation, QMS refinement and Notified Body management.

    We also write SSCPs where required and help obtain UDI-DIs and other submission components that are unique to MDR / IVDR. You will be provided with a single quote that covers all key aspects of the work that are relevant to your device, providing full transparency and certainty from the start.

  2. Yes – we offer full support with Notified Body selection, engagement, quoting, contracting, dossier submission and question resolution until a Certificate of Conformity has been fully granted. You will be fully supported through the entire process.

  3. As a core component of the service, we also ensure you are in conformity with the EU AI Act (as relevant), GDPR, domestic laws and other relevant European regulations.

  4. We ensure you stay certified through comprehensive ongoing support covering PMS, vigilance & PMCF as you move into the post-certification phase. Fully compliant PMS and PMCF Plans are included within the core service; local support with ongoing collection and analysis of safety and performance data form additional packages of work, according to scope and client requirements.

  5. The service includes support with EUDAMED registration and Competent Authority communication, with access to professional translation services for the latter if required.

    As a component of our post-approval services, we can handle inbound market data (complaints, adverse events) on your behalf, without you needing any native language speakers or a physical presence in-market.

  6. The core service is delivered entirely in-house by Mantra Systems, the only exception being professional translation of user-facing materials.

    Upon request, we will be delighted to provide access to our carefully curated partner network, enabling links to companies specialized in Authorized Representative / PRRC services, health economics, marketing, and sales & logistics in your target territories.

  7. Yes – One of the key challenges in bringing a product into the European market is ensuring that user-facing materials are provided in English and appropriate local languages. Through professional translation partners, we ensure your IFU, patient information leaflets and SSCPs (as relevant) are appropriately translated. This is fully included in the service.

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