Masterarbeit

A comparison of the regulatory requirements for the conduct of clinical trials respectively performance studies for medicinal products, medical devices and in-vitro diagnostic medical devices according to the European regulations (EU) 536/2014, (EU) 2017/745 and (EU) 2017/746

Dr. Harald G. Engemann (2023)

Summary
Language: English
The comparison of regulatory requirements for the conduct of clinical trials for medical products and medical devices and performance studies for in-vitro diagnostic medical devices according to European regulations (EU) 536/2014, (EU) 2017/745, and (EU) 2017/746 has revealed several key findings.
Sponsors play a vital role in ensuring compliance with regulatory obligations. They are responsible for submitting regulatory submissions and necessary notifications, and actively participating in safety reporting and vigilance activities. Competent authorities have the responsibility of authorizing and overseeing clinical trials and performance studies. They play a crucial role in the assessment and approval processes, conducting inspections and ensuring compliance with regulatory requirements.
Ethical considerations are paramount in both clinical trials and performance studies. Obtaining informed consent from participants is a fundamental requirement, along with protecting their rights and well-being throughout these types of studies. Data protection are also important considerations to safeguard participants' personal information.
Investigators have specific responsibilities in conducting clinical trials and performance studies. They must possess appropriate qualifications and training, conduct these types of studies according to protocols, report safety information and manage adverse events, and maintain accurate recordkeeping and documentation throughout the study.
Patient rights are a crucial aspect of these types of studies. Participants have the right to provide informed consent based on comprehensive information about the study. They should have access to relevant study information and their personal data should be protected. Participants also retain the right to withdraw from the study at any time without facing negative consequences.
Each regulation has its own set of specific requirements for clinical trials and performance studies. These requirements encompass various aspects such as the conduct of these types of studies, performance evaluation, post-market surveillance, and the generation of clinical evidence. While there are similarities in certain obligations and requirements across the regulations, there are also notable differences, particularly in terms of the specific requirements for each category of investigational product.
In addition to the findings, the comparison highlights challenges, and future perspectives in the field. Harmonization efforts among regulatory authorities, implications of regulatory changes, and emerging trends and developments are important considerations for stakeholders involved in clinical trials and performance studies.
It is essential for stakeholders to be aware of these findings and key takeaways to ensure compliance with the regulatory framework and to safeguard the rights and well-being of participants in clinical trials and performance studies. Recommendations include thorough understanding and compliance with specific obligations, establishing robust systems for regulatory submissions and safety reporting, collaborating with competent authorities, acquiring appropriate qualifications, prioritizing patient safety, and staying updated with regulatory changes.
Stakeholders should refer to the respective European regulations, guidelines, and authoritative sources for comprehensive details and to stay informed about the evolving regulatory landscape. By following these recommendations and considering the key takeaways, stakeholders can ensure the successful and ethical conduct of clinical trials and performance studies while protecting the rights and safety of participants.
Pages: 53
Annexes: 0, Pages: 0