| Category | Research Proposal | Subject | Management |
|---|---|---|---|
| University | Griffith College Dublin | Module Title | Module 3: Research Methods |
| Word Count | 2500 Words |
|---|---|
| Academic Year | 2026/27 |
The European Union introduced the Medical Device Regulation (MDR) 2017/745 in May 2021 to replace the Medical Device Directive (MDD) and improve medical device safety and performance. It introduced stricter clinical evaluation and monitoring requirements (Majety et al., 2021; McDermott & Kearney, 2025).
Manufacturers face challenges such as higher costs, longer approval processes, and limited resources, especially small and medium-sized businesses (Kearney & McDermott, 2023a; Melvin et al., 2023).
This study examines these challenges and identifies solutions to help manufacturers meet MDR requirements while maintaining patient safety.
Part 1: Introduction
Part 2: Secondary research strategy
Introduction
1. Key Changes in MDR Related to Clinical Evaluation
2. Challenges Faced by Manufacturers
3. Impact on Small and Medium-Sized Enterprises (SMEs)
4. Strategies and Best Practices for Compliance
5. Broader Impacts on Innovation and Market Access
Critique of Peer-Reviewed Source
Part 3: Primary Research Strategy Plan
References
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