Making clinical investigations work better under MDR/IVDR: insights from Healixia

At the Healixia Conference on 22 October, Lauren Swinnen, Regulatory Specialist of Archer Research, shared practical insights into one of the key challenges facing MedTech sponsors today: how to successfully navigate clinical investigations in Europe under the MDR and IVDR. Her central message? While the regulatory environment is complex, many of the obstacles that delay clinical investigations are predictable, and can be addressed much earlier in the process.

A stronger framework, with real-world complexity

The MDR and IVDR have strengthened the European regulatory framework, bringing greater focus on patient protection, ethics, clinical evidence, transparency and clearly defined sponsor responsibilities. At the same time, their implementation has introduced significant operational complexity for sponsors.

Despite European regulations providing a common framework, sponsors still have to navigate differences between Member States in submission routes, fees and timelines. Ethics Committee and Competent Authority procedures can run differently, while IVD performance studies and combined drug-device studies may introduce additional regulatory requirements.

MDR and IVDR are evolving

The regulatory landscape itself is also changing. The European Commission proposed a targeted revision of the MDR and IVDR in December 2025, with the aim of simplifying the regulatory framework and making Europe a more attractive and predictable environment for MedTech innovation. The proposed changes touch several areas relevant to clinical investigations and performance studies, including clinical evidence requirements, certain IVD performance studies, combined studies and opportunities for earlier scientific dialogue.

However, the revision remains a proposal and is subject to change. Until new rules are adopted, today’s MDR/IVDR requirements and national submission routes continue to apply.

For sponsors planning investigations now, the implication is clear: future simplification may help, but successful studies still need to be designed for the regulatory and operational reality of Europe today.

Most delays are predictable

One of the key themes of Lauren’s presentation was that many of the issues that slow down a clinical investigation should not come as a surprise. Unclear regulatory pathways, documentation that is not fully adapted to EU requirements, validation questions, different document versions reaching authorities, contracts starting too late, insurance and customs requirements, and country-specific data protection considerations can all affect timelines.

Crucially, many of these challenges can already be identified at the study design stage, when they are generally easier and less costly to address than after submission.

That might mean confirming the appropriate European regulatory pathway before finalising the protocol, ensuring the CIP, Investigator’s Brochure and informed consent materials are EU-ready, selecting countries based on realistic EC and NCA timelines, or starting contracts, insurance and data-protection activities in parallel rather than sequentially.

Turning complexity into a plan through early collaboration

This is where early collaboration between sponsors and an experienced European CRO can make a meaningful difference.

Bringing the CRO into discussions while the study is still being designed creates an opportunity to assess regulatory and operational feasibility before key decisions become difficult or expensive to change. Country and site selection can reflect actual regulatory pathways and timelines. Documentation can be developed with European requirements in mind from the outset. Contracts and other start-up activities can begin earlier. Budgets and timelines can also be built around the realities of conducting the study in Europe.

By contrast, involving a CRO only after a protocol has been finalised can mean retrofitting a study designed for another regulatory environment, discovering validation issues during submission, or losing valuable time because contracts and other operational activities started too late.

The goal is not simply to manage complexity once it appears. It is to anticipate it and translate it into a realistic plan from the beginning.

Three takeaways for MedTech sponsors

Lauren concluded the session with three messages:

• MDR and IVDR remain challenging frameworks. The targeted revisions aim to make Europe more attractive for MedTech innovation.

• Most delays in clinical investigations are predictable. Anticipating them at the design stage can help prevent avoidable setbacks.

• Early collaboration matters. Early sponsor-CRO alignment can turn regulatory and operational complexity into a clear, actionable plan.

  
  

At Archer Research, this is at the heart of how we approach clinical investigations: combining regulatory and operational expertise early enough to make a difference, and helping sponsors build clinical evidence strategies that work in the European environment.

Planning a clinical investigation or performance study in Europe? Get in touch with Archer Research to discuss how early regulatory and operational planning can help make your study more efficient and predictable