Module 12
Medical Device Regulatory Affairs
Aim
To provide students with a good appreciation of the regulatory control of medical devices particularly within the European Union. After participation in the Module, students should be able to provide strategic advice on the application of the medical device directives to enable products to be CE-Marked and on key international legislation.
Learning outcomes
- Students will distinguish the routes to Conformity Assessment in the EU.
- Students will assess the role of the Competent Authorities and the Notified Bodies.
- Students will define the requirements of post-market surveillance and vigilance, and the role that risk management plays throughout the lifecycle of a device.
- Students will identify the documentation requirements for CE-Marking and the application of Harmonised Standards.
- Students will compare how medical devices are regulated in other markets and examine related international activities such as the Global Harmonisation Task Force.
- Students will interpret the requirements of clinical evaluation, how to initiate a clinical study and the ever increasing impact of Health Technology Assessment.
Outline of Module topics
- The New Approach legislative environment in the European Union and the medical devices directives
- Conformity Assessment procedures
- Clinical evaluation
- Essential Requirements and Standards
- Risk-based classification system
- Post-market surveillance including vigilance
- Risk analysis and risk management
- The role of the Competent Authority and the Notified Body
- Medical device legislation in other markets and the Global Harmonisation Task Force
- Labelling for medical devices
- Devices containing drugs and borderline products
- In-vitro diagnostics.