Authors
Tuncay Bayrak
Published in
Therapeutic innovation & regulatory science. Aug 21, 2025. Epub Aug 21, 2025.
Abstract
Medical devices used in health care should fulfill the requirements of the technical regulations to protect patient health. Difficulties in enforcing stricter rules in the new medical device regulations may negatively affect the continuity of care. This study examines the status of manufacturers' compliance with medical device regulations, based on predefined criteria, and proposes a collaborative action plan and an approach to verify regulatory compliance. We conducted a nationwide survey comprising questions grouped by criteria to understand the status of the manufacturers in terms of compliance with the Medical Device Regulation. Four hundred sixty-seven manufacturers participated in the survey. We achieved a Cronbach's alpha of 0.77, which indicates that the survey is statistically reliable. We applied the independent samples t-test to the responses to determine significant features per question and employed factor analysis to investigate the relationships of the questions. The results of independent samples t-tests showed statistically significant differences across groups in replies to several survey items (p < 0.05), indicating that participants' opinions varied based on their demographic characteristics. We applied Exploratory Factor Analysis to introduce the relationships between the questions. The analysis revealed that manufacturers continue to face substantial challenges in acquiring sufficient knowledge and operational capability to meet MDR requirements. In light of these findings, we focused on the person responsible for regulatory compliance, who plays a central role in maintaining regulatory compliance within manufacturing organizations. We proposed an action plan at the macro level to introduce more effective action plans in cooperation with other stakeholders, including healthcare providers, and a verification approach for regulatory compliance to enhance the Person Responsible for Regulatory Compliance's competence. Manufacturers should implement effective postmarketing clinical follow-up plans involving device-oriented parameters for monitoring in the healthcare system, especially in collaboration with health professionals.
PMID:
40839208
Bibliographic data and abstract were imported from PubMed on 21 Aug 2025.
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