What is EN ISO 14155-2:2021?

EN ISO 14155-2:2021 is an international standard that provides guidelines for the conduct of clinical investigations of medical devices, specifically focusing on the ethical and scientific aspects of these studies. It serves as a reference document for manufacturers, regulators, and researchers involved in the development and evaluation of medical devices.

Key Principles of EN ISO 14155-2:2021

The standard emphasizes several key principles to ensure that clinical investigations are conducted ethically and produce reliable results. These principles include:

Informed Consent: Participants must provide their freely given informed consent before participating in a clinical investigation. They should be provided with all relevant information about the study, its purpose, potential risks and benefits, and their rights as participants.

Ethics Committee Approval: All clinical investigations must undergo independent review and approval by an ethics committee or institutional review board (IRB). This ensures that the study meets ethical standards and protects the rights and well-being of participants.

Risk Assessment and Mitigation: The standard emphasizes the importance of assessing and managing risks associated with the investigational medical device. This includes identifying and minimizing potential adverse events, ensuring participant safety, and providing appropriate medical care throughout the study.

Data Management and Analysis: EN ISO 14155-2:2021 highlights the need for accurate and reliable data collection, management, and analysis during clinical investigations. This ensures that the results are valid and can be used to draw meaningful conclusions about the safety and performance of the medical device.

Benefits and Impact of EN ISO 14155-2:2021

The implementation of this standard brings several benefits and impacts to the medical device industry and clinical research community:

Enhanced Patient Safety: By adhering to ethical guidelines and rigorous scientific standards, EN ISO 14155-2:2021 helps ensure that patients participating in clinical investigations are protected from unnecessary risks and harm.

Improved Quality of Data: Following the standard's requirements for data collection, management, and analysis enhances the reliability and accuracy of the results. This, in turn, allows researchers and regulators to make informed decisions based on robust evidence.

Harmonization of Practices: The standard helps harmonize practices and procedures related to clinical investigations across different countries and regions. This facilitates the acceptance and recognition of study data by regulatory authorities, expediting the approval and market access process for medical devices.

Increased Stakeholder Confidence: Compliance with EN ISO 14155-2:2021 demonstrates a commitment to conducting high-quality clinical investigations. This can enhance stakeholders' confidence in the safety, efficacy, and reliability of the investigated medical device.

In conclusion, EN ISO 14155-2:2021 plays a crucial role in ensuring the ethical conduct and scientific rigor of clinical investigations for medical devices. Adhering to this standard not only protects patient rights and safety but also promotes reliable data collection and analysis. By harmonizing practices and increasing stakeholder confidence, EN ISO 14155-2:2021 contributes to the development and evaluation of safe and effective medical devices that benefit both healthcare professionals and patients alike.