EU Trials Involving Medical Devices Under MDR/IVDR

Published on 21/12/2025

Clinical Trials of Medical Devices in the EU: Navigating MDR and IVDR Requirements

The European Union (EU) has transformed its regulatory landscape for medical devices and in vitro diagnostics with the introduction of the Medical Device Regulation (MDR, Regulation (EU) 2017/745) and the In Vitro Diagnostic Regulation (IVDR, Regulation (EU) 2017/746). These frameworks impose stricter requirements for clinical investigations, transparency, and post-market surveillance. Unlike pharmaceutical clinical trials governed under CTR 536/2014, device trials follow specific procedures coordinated by national competent authorities and Notified Bodies, with EMA involvement in borderline and combination products. Sponsors must ensure compliance with safety reporting, ethics committee oversight, and device-specific Good Clinical Practice (ISO 14155). MDR and IVDR have elevated expectations for evidence generation, ensuring that devices marketed in the EU meet high standards of safety and clinical performance.

This article explores how clinical trials of medical devices are regulated under MDR and IVDR, highlighting differences from pharmaceutical trials, key obligations for sponsors, and strategies for achieving compliance.

Table of Contents

Background and Regulatory Framework

MDR and IVDR Implementation

MDR and IVDR replaced the Medical Devices and IVD Directives in 2021 and 2022, respectively. They introduce stricter clinical evidence requirements, centralized oversight, and transparency obligations for

sponsors.

EMA and National Authority Roles

While EMA oversees medicinal products, it coordinates with Member States on combination products and provides scientific opinions on certain high-risk devices. National competent authorities remain responsible for authorizing most device trials.

Notified Bodies

Notified Bodies are designated organizations that assess conformity of devices and verify clinical evidence before CE marking. Under MDR/IVDR, their role in trial-related documentation and approvals has increased substantially.

Core Clinical Trial Insights: MDR/IVDR Trials

1. Clinical Investigations vs. Clinical Trials

Device research is referred to as a clinical investigation. These differ from drug trials but must meet equivalent standards of participant protection, ethics approval, and GCP compliance.

2. ISO 14155 Compliance

Clinical investigations must follow ISO 14155, the international GCP standard for medical device research. This ensures scientific validity, participant safety, and harmonization with EU requirements.

3. Application and Authorization

Unlike pharmaceuticals, device trial applications are submitted to national authorities, not via CTIS. However, sponsors must still meet EU-wide MDR transparency rules, including registration in EUDAMED.

4. Safety Reporting

Adverse events must be reported according to MDR and IVDR timelines. Serious adverse device effects (SADEs) and device deficiencies must be documented and communicated to regulators.

5. Combination Products

Trials involving both medicinal products and devices, such as drug-device combinations, require coordinated regulatory review between EMA and national device authorities.

6. Transparency and EUDAMED

MDR and IVDR mandate registration of device investigations in EUDAMED, the EU’s database for device information, ensuring public access to trial data, approvals, and outcomes.

7. Pediatric and Rare Disease Device Trials

Special challenges include limited patient populations, ethical consent processes, and additional scrutiny from ethics committees. Case studies demonstrate the need for multi-country collaboration.

8. Common Inspection Findings

Inspections often identify:

Incomplete documentation of device deficiencies
Delayed reporting of SADEs
Inadequate risk management plans
Failure to comply with ISO 14155 requirements

Best Practices & Preventive Measures

Ensure alignment of protocols with MDR/IVDR and ISO 14155.
Engage early with national competent authorities for device-specific guidance.
Maintain strong quality management systems to support trial conduct.
Train investigators in device-specific GCP and safety reporting.
Prepare for inspections by documenting device performance, deficiencies, and adverse events thoroughly.

Scientific and Regulatory Evidence

Regulation (EU) 2017/745 – Medical Device Regulation (MDR)
Regulation (EU) 2017/746 – In Vitro Diagnostic Regulation (IVDR)
ISO 14155 – Clinical Investigations of Medical Devices
EU EUDAMED Guidance
EMA/Notified Body joint guidance on combination products

Special Considerations

Device trials face unique challenges compared to pharmaceuticals:

Oncology Devices: High-risk implants require rigorous safety and performance documentation.
Pediatrics: Additional ethical safeguards and device design considerations are mandatory.
Rare Diseases: Small patient populations demand innovative trial designs and EU-wide collaboration.
Decentralized Trials: Remote device monitoring introduces GDPR and validation challenges.

When Sponsors Should Seek Regulatory Advice

When developing trials for novel, high-risk, or combination devices.
If integrating digital health components into medical device studies.
When facing challenges harmonizing approvals across Member States.
For pediatric or rare disease device trials requiring tailored strategies.
If inspection findings reveal gaps in ISO 14155 compliance.

FAQs

1. What regulations govern medical device trials in the EU?

They are governed by MDR (EU 2017/745) and IVDR (EU 2017/746), not CTR 536/2014, although EMA may be involved in combination products.

2. How are device trials different from drug trials?

They are termed clinical investigations, overseen by national authorities and Notified Bodies, with ISO 14155 as the GCP framework.

3. What is EUDAMED?

EUDAMED is the EU’s central database for medical devices, where sponsors must register device trials and results for transparency.

4. What role does EMA play in device trials?

EMA provides input for combination products and borderline cases but does not directly authorize most device investigations.

5. Are pediatric device trials regulated differently?

Yes. They require stricter ethical review and tailored device designs to ensure safety for children.

6. What are common compliance gaps?

Incomplete risk management, delayed reporting of SADEs, and poor ISO 14155 compliance are frequent inspection findings.

7. When should sponsors consult regulators?

Early in development, especially for high-risk devices, novel technologies, or pediatric and rare disease trials.

Conclusion

Clinical trials involving medical devices in the EU are subject to MDR and IVDR, which strengthen evidence requirements, transparency, and patient protection. Sponsors must align with ISO 14155, engage national authorities, and register trials in EUDAMED. EMA plays a supporting role in combination products and scientific advice. By adopting best practices, maintaining strong oversight, and ensuring rigorous safety reporting, sponsors can achieve compliance while advancing innovation in the EU’s evolving device landscape.