The Medical Devices Introductory Course 2020

Medical Device Introductory Course Aims

To provide a good appreciation of the regulatory control of medical devices, particularly in the EU, in order to offer effective practical advice on the application of medical device legislation to enable products to be CE-marked.

The Organisation for Professionals in Regulatory Affairs

Principles of Medical Device Regulation in Europe - Learning Outcomes

Ability to classify devices, distinguish conformity assessment routes and identify key quality, safety and performance requirements to CE Mark a device in the EU

Understanding of the role of the competent authorities and the notified bodies

Confidence to define the requirements of post-market surveillance and vigilance, and the role that risk management plays throughout the device lifecycle

Understanding of the borderline between medical devices and medicinal products

Appreciation of how medical devices are regulated in other key markets.

The Organisation for Professionals in Regulatory Affairs