To place a medical device on the European market, device firms are required to demonstrate conformity of the device with the relevant essential requirements for the device’s clinical safety and performance for CE marking. In particular, clinical evaluation is required to ensure that there is sufficient clinical evidence to support the device safety and performance when used as indicated throughout the lifetime of the medical device on the market. Clinical evaluation applies to all classes of medical devices.
In this seminar, the speaker will discuss recommended guidelines on how to perform and document clinical evaluation and clinical evaluation report as one of key elements of the technical documentation for CE marking purposes.
The speaker will walk you through the current recommended guidelines and practices.
- Applicable Laws
- CE Marking
- Clinical Evaluation Requirements
- Clinical Evaluation: Format and Contents
- Key Considerations
- Common Mistakes
- PASS-IT Recommendations for Best Practices: Dos and Don’ts
- Research and Development Departments
- Quality Departments
- Regulatory Affairs Departments
- Engineering Departments
- Clinical Affairs Departments
- Compliance Officers