Master's Thesis Unveils Challenges in Harmonizing Clinical Evaluation Processes for Medical Device Software in the EU
A Master's thesis exploring the problems of harmonization of clinical evaluation processes for medical device software (MDSW) in the European Union.
Key stakeholders in the MDSW field, including policymakers, regulators, manufacturers, healthcare professionals, and researchers, participated in the study. Their diverse perspectives offered a comprehensive understanding of the multifaceted challenges at hand and practical recommendations for the EU Horizon 2020 SHAPES (Smart and Healthy Aging through People's Participation in Support Systems) pilot project.
In the dynamic landscape of evolving regulatory frameworks, harmonizing clinical evaluation processes for MDSW in the EU remains challenging. The crucial role of clinical evaluation in ensuring general safety and performance requirements is highlighted by the EU Regulations, such as the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).
The study delved into the regulatory landscape governing MDSW in the EU by engaging industry experts in discussions that unveiled critical connections between the existing regulatory framework and the hurdles faced by MDSW manufacturers and developers in meeting compliance requirements. Interviews exposed the complexities of harmonizing of clinical evaluation of MDSW across EU member states, as well as citing disparities in competent authorities' and notified bodies' requirements, the absence of standardized approaches to clinical trials, and national variations in Real-World Data utilization.
Despite the recent great achievements in this field, the current study underscores the pressing need for further ongoing collaboration, transparency, and an intricate comprehension of the evolving regulatory environment for the harmonization of clinical evaluation of MDSW. By addressing these challenges, the EU, exemplified through projects like the SHAPES pilot, is poised to lead the way toward an efficient approach to ensuring the safety and performance of MDSW. This forward-looking initiative holds the potential to benefit industry stakeholders and the broader healthcare ecosystem.
You can find Anna Polishchuk's thesis Exploring the challenges in the harmonization of clinical evaluation of medical device software across EU member states at Theseus.
For further information, please contact:
Anna Polishchuk
Laurea University of Applied Sciences
Global Health and Crisis Management Programme
anpoli_anna@hotmail.com