EUHA_WHITE_HEALTHCARE

Our work

MDR/IVDR Network

The Medical Devices Regulation and In-Vitro Diagnostic Regulation (MDR/IVDR) Network fosters collaboration and knowledge exchange among EUHA members, enhancing expertise in the implementation and compliance of MDR/IVDR. By identifying shared challenges, it drives continuous improvement across member institutions and supports a sustainable regulatory environment that fosters high-quality, patient-centered care. Additionally, the network engages in strategic advocacy at the EU level and focuses on promoting regulatory frameworks that recognise the unique role of university hospitals, protect their capacity for innovation, and address challenges related to the availability of medical devices.

The expert network for European cooperation in MDR/IVDR

Since the implementation of the Medical Device Regulation (MDR) in May 2021 and the In Vitro Diagnostic Regulation (IVDR) in May 2022, university hospitals have faced significant challenges. Among several critical issues are the reduced availability of medical devices and the adverse effects on innovation within clinical environments. Article 5(5) of the IVDR, which introduces specific conditions for the use of in-house developed tests by health institutions, has added further complexity, particularly for university hospitals that rely on such diagnostics to address rare or unmet medical needs.

Recognising the impact of MDR/IVDR, EUHA university hospital experts have joined forces to assess their effects on patient care and innovation, exchange strategies and best practices, and strengthen collaboration. To this end, the EUHA MDR/IVDR network facilitates structured knowledge sharing, promotes peer learning through experiences and success stories, and develops vision statements that guide advocacy at the European level, highlighting the essential role of university hospitals and proposing policy revisions where needed.

EUHA Collaborative Response

In light of the ongoing challenges posed by the MDR and IVDR, experts from EUHA hospitals are working collaboratively to:

Share insights and experiences on the impact of MDR and IVDR within their institutions, and explore effective ways to navigate the evolving regulatory landscape.

Exchange strategies and preparations across EUHA members to foster mutual learning and highlight best practices in adapting to the new requirements.

Develop vision statements to strengthen strategic advocacy at the European level, underlining the essential role of university hospitals and identifying key areas for policy refinement. Through this collective effort, the EUHA network seeks to build institutional resilience, advocate for a sustainable and innovation-friendly regulatory environment, and safeguard access to high-quality, patient-centered care.

About this Network

Knowledge Sharing
This network promotes knowledge sharing and strengthens expertise in implementing and complying with MDR and IVDR regulations. By identifying common challenges and insights, it contributes to structural improvements within the member institutions.

Emphasising the Role of University Hospitals at the EU Level
The network actively advocates for regulatory frameworks that acknowledge the distinct role of university hospitals within the European healthcare system. It calls for policy adjustments that safeguard their capacity for innovation, ensure the continued use of safe in-house IVDs and MDR-compliant devices, and address persistent challenges related to the availability of medical technologies. These efforts aim to support the delivery of high-quality, research-driven, and patient-centered care across Europe.

Facilitating Knowledge Exchange
EUHA members actively share experiences related to the implementation of MDR and IVDR regulations. Through peer exchange on adaptation strategies, operating models, and successful case studies, the network identifies shared challenges and contributes to collective learning and improvement.

Strategic Advocacy and Policy Engagement
The MDR/IVDR network, in collaboration with other EUHA networks, seeks to be recognised as a key stakeholder and discussion partner in European health policy. Its primary focus is on addressing the specific implications of the MDR and IVDR regulations for university hospitals, while also considering their broader impact on the healthcare ecosystem.

Coordination

Kelly van der Geest


Rotterdam, NL

Sebastian Notenboom


Rotterdam, NL

Erasmus MC University Medical Centre

Eisabeth Dequeker


Leuven, Belgium

UZ Leuven

Related news