Clinical

Clinical Investigations Under MDR

The EU MDR has brought greater consistency to clinical investigations, but navigating the process across Member States is still far from straightforward.

From regulatory pathways and ethics approvals to tight timelines and post-market requirements, successful execution starts with knowing what to expect.

Discover the key MDR requirements and practical lessons for planning and conducting medical device clinical investigations in Europe.

About This White Paper

The Medical Device Regulation has significantly raised the bar for clinical evidence, regulatory oversight and post-market surveillance in Europe. Manufacturers must carefully assess whether their existing clinical data is sufficient, and where gaps remain, additional pre-market or post-market clinical investigations may be needed.

This white paper combines MDR requirements with practical experience from medical device clinical investigations across Europe. It explains how to determine the appropriate regulatory pathway, navigate submissions to competent authorities and ethics committees, and account for country-specific differences that still exist despite the MDR's harmonization goals.

You'll also gain insight into MDR timelines, the role of the EU Legal Representative, reporting requirements during study conduct and the growing importance of Post-Market Clinical Follow-up (PMCF), along with a look at how EUDAMED and coordinated assessments could further simplify European clinical investigations in the future.

Key Takeaways

✓ Determine the Right MDR Regulatory Pathway. Understand how factors such as CE-marking status, intended purpose and the role of the investigation in conformity assessment determine whether Article 62, Article 74 or other provisions apply.

✓ Navigate Country-Specific Submission Requirements. Learn why differences between Member States remain, particularly around regulatory assessment and ethics committee review, and why country and site selection can directly affect your submission strategy and timelines.

✓ Prepare for Strict MDR Timelines. Understand the authorization process, Requests for Information and sponsor response windows, and why a complete, accurate submission package is critical to avoiding unnecessary delays.

✓ Understand the Role of the EU Legal Representative. Discover what sponsors outside the EU need to know about appointing a Legal Representative, including their increased responsibilities and role as a key point of contact under MDR.

✓ Manage MDR Requirements Throughout Study Conduct. Get familiar with reporting obligations for study start and end, safety events and other key milestones, and understand where MDR has created greater consistency across European countries.

✓ Plan for Post-Market Clinical Evidence. Explore the growing role of PMCF and the different approaches manufacturers can use to continuously gather evidence on device safety and performance after market launch.

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