INTRODUCTION

Since the implementation of the Medical Device Regulation (MDR) in 2017, the scope and complexity of work associated with clinical evaluations have grown substantially. This increased workload reflects the heightened regulatory requirements and the rigorous standards now expected for medical device validation. 

The primary objective of this survey is to systematically assess how clinical evaluations conducted under the MDR impact the availability of medical devices in the market and whether these evaluations contribute to improved safety for patients, based on the perspectives of manufacturers, Notified Bodies, and consultants.

By exploring these effects, the survey aims to provide evidence-based insights into whether the expanded clinical evaluation process contributes to improved patient safety and access to innovative medical technologies, or if it inadvertently imposes barriers that limit product availability and affect patient care. The findings will help inform stakeholders and guide future regulatory and clinical practices.

Participation in this survey is expected to require approximately five minutes. All responses will remain entirely anonymous to ensure confidentiality. However, if you are interested in receiving the results or further information regarding the outcomes of this study, please contact the research team at [email protected].