What is EN ISO 14155:2011?

EN ISO 14155:2011 is an international standard for the conduct of clinical investigations of medical devices. It provides guidelines and requirements for medical device manufacturers on how to design, conduct, and report clinical trials. This standard ensures that the clinical investigations are carried out in a scientifically sound manner, ensuring patient safety and data integrity.

Key Requirements of EN ISO 14155:2011

The standard encompasses various key requirements that must be followed during the conduction of clinical investigations. First and foremost, it emphasizes the need for ethical considerations and obtaining informed consent from participants. The standard also establishes criteria for selecting suitable study subjects, considering factors such as age, gender, and medical history. Additionally, it addresses the importance of expert input, stating that studies should be conducted and overseen by qualified professionals with relevant expertise.

Implementation and Compliance

Implementing and complying with EN ISO 14155:2011 is crucial for medical device manufacturers. Compliance ensures that clinical investigations are conducted with precision and adherence to ethical principles, safeguarding both patients and the integrity of the collected data. Manufacturers should establish clear protocols and procedures in accordance with the standard, ensuring consistent application across all clinical trial sites. Adhering to EN ISO 14155:2011 enhances the credibility and reliability of the clinical investigation results, increasing the chances of regulatory approval and market acceptance.

Benefits and Impact

EN ISO 14155:2011 brings numerous benefits and impacts to the field of medical device research. By setting clear standards and requirements, it promotes harmonization and consistency in clinical trial practices across different countries. This facilitates collaboration and the sharing of information between researchers and sponsors worldwide. Moreover, the standard's focus on patient safety and ethical considerations protects study participants from potential harm. Lastly, by ensuring that clinical investigations are conducted with rigor, data reliability and accuracy are improved, supporting evidence-based decision-making in medical practice.