The decision to run a structural heart or coronary device trial in Europe is usually straightforward. The European market matters, investigator networks are highly experienced, and increasingly, the evidence generated in European centres is shaping global clinical practice.
The harder question is: what does getting started actually look like when you have no existing European presence and the regulatory framework is entirely new to you?
The answer is more structured than most non-EU sponsors expect, and more manageable than it first appears, provided the process is approached in the right order.
The Legal Foundation Comes First
Before any clinical activity can begin in Europe, a non-EU manufacturer must appoint an EU Authorised Representative (AR).
This is a legal requirement under MDR Article 11, not a procedural formality. The AR shares regulatory liability with the manufacturer and acts as the interface with national competent authorities and notified bodies.
Without an AR in place, clinical investigation applications cannot be submitted in European Member States.
Establishing the AR relationship early, ideally before protocol development begins, also provides access to country-specific regulatory intelligence. That insight can significantly influence broader clinical and operational strategy.
Country Selection Is a Clinical Decision
For first-time European structural heart investigations, Belgium and the Netherlands are often efficient starting points. Regulatory timelines are relatively short, ethics review processes are centralized, and both countries benefit from strong academic cardiology infrastructures.
For indications requiring larger patient volumes or more complex patient populations, particularly in transcatheter aortic valve implantation (TAVI) or transcatheter mitral repair studies, Germany and France provide access to scale and procedural complexity that can strengthen dataset quality.
One of the most common and costly mistakes is selecting countries primarily based on existing relationships rather than patient access, operational feasibility, and site suitability.
Your Protocol Needs to Be Built for Europe from the Start
A protocol developed for a US FDA Investigational Device Exemption (IDE) study is not automatically suitable as an EU Clinical Investigation Plan (CIP).
The MDR Annex XV framework introduces specific expectations around:
- benefit-risk documentation
- stopping rules
- safety monitoring
- clinical evidence justification
For structural heart investigations specifically, endpoint strategies should align with Valve Academic Research Consortium-3 (VARC-3) recommendations, while quality-of-life measures such as the Kansas City Cardiomyopathy Questionnaire (KCCQ) should be predefined from the outset rather than introduced later.
Ethics committee submissions also require:
- national language translations
- country-specific informed consent wording
- coordination across multiple committees in certain countries
France and Germany, in particular, may require more complex coordination structures.
None of these requirements are unmanageable, but they can extend activation timelines significantly if not anticipated early.
Post-Market Follow-Up Starts During Planning, Not After CE Marking
One of the more important mindset shifts for non-EU manufacturers is understanding that Post-Market Clinical Follow-Up (PMCF) does not begin after CE marking.
Under the MDR framework, PMCF planning forms part of the conformity assessment dossier itself.
The PMCF plan must describe how clinical evidence will continue to be generated throughout the commercial lifecycle of the device.
For structural heart technologies, the most efficient PMCF strategies often integrate data collection into existing European cardiovascular registries. Leveraging infrastructures that are already validated and familiar to clinical sites can significantly improve operational efficiency and long-term evidence generation.
Building the Right European Strategy from the Start
Europe offers major opportunities for structural heart and coronary device innovation, but entering the region successfully requires more than translating an existing US strategy into a European setting.
Regulatory frameworks, operational structures, site expectations, and evidence requirements all introduce nuances that need to be addressed proactively.
For sponsors entering Europe for the first time, early planning and local expertise can significantly reduce delays, improve feasibility, and strengthen long-term clinical evidence strategies.
Planning Your First European Structural Heart Investigation?
QbD Group supports non-EU manufacturers throughout the full European clinical investigation pathway, from EU Authorised Representative appointment and country strategy through clinical investigation execution and Post-Market Clinical Follow-Up planning.
Looking to discuss your European structural heart or coronary trial strategy? Get in touch with our Clinical Evidence & Trial Design experts to explore how we can support your programme from the ground up.
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