A comprehensive document that assesses the safety and performance of a medical device or product through the evaluation of clinical data gathered from various sources.
A set of regulations governing the manufacture, distribution, and use of medical devices in the European Union, which mandates the creation of CERs for certain classes of medical devices.
Information collected from clinical investigations, post-market surveillance, scientific literature, and other relevant sources, used to evaluate the clinical safety and performance of a medical device.
A systematic examination of published scientific literature relevant to the medical device under evaluation, providing insights into its safety, efficacy, and performance.
The process of identifying, assessing, and mitigating potential risks associated with the use of a medical device, which is integral to the evaluation conducted within a CER.
Ongoing monitoring of a medical device’s performance and safety in real-world clinical settings after it has been placed on the market, contributing valuable data to the CER.
A study conducted to gather clinical data on the safety and performance of a medical device in human subjects, often required for high-risk devices and essential for CERs.
An evaluation of the potential benefits versus the potential risks associated with the use of a medical device, crucial for determining its overall suitability for clinical use.
An examination of existing technologies, methodologies, and standards relevant to the medical device being evaluated, providing context for understanding its place in the current market landscape.
In-depth knowledge and experience of healthcare professionals involved in the evaluation of clinical data, contributing to the interpretation and analysis within the CER.
Mandatory criteria established by regulatory authorities that medical devices must meet to ensure their safety and performance, guiding the evaluation process within a CER.
A structured plan outlining the methodology and approach for conducting the clinical evaluation of a medical device, serving as a roadmap for CER development.
Independent organizations designated by regulatory authorities to assess the conformity of medical devices with applicable regulations, often involved in the review and approval of CERs.
A document providing an overview of the safety profile of a medical device based on ongoing surveillance and post-market data, informing updates to the CER as needed.
Summarized findings and suggestions derived from the CER, guiding regulatory decision-making and informing stakeholders about the safety and performance of the medical device.