This is a basic online course for beginners that want to start learning about European Medical Device Regulatory Basics. The material breaks down the essential governmental structure of the EU and how this relates to the three different directives for medical devices: Medical Device Directive 93/42/EEC, In Vitro Device Directive 98/79/EC, and Active Implantable Medical Device Directive 90/385/EEC. Once establishing this framework, the course covers the different regulatory organizations and documents needed to gain a CE Mark allowing a device to be sold in the EU. Details are given for construction of Technical Files and Design Dossier. The course is 100% online and modeled after the “Medical Device Development” class taught at the New Jersey Institute of Technology since 2009. This course assumes no prior knowledge of medical devices or their development. New students should be able to understand the entire content with no prior background.
European Medical Device Regulatory Basics Course Objectives:
- Be able to tell differences between EU and US approach to medical device regulation
- Understand how to begin the regulatory process in EU for your device
- Have a basis for pursuing further information on EU medical device regulation
Who should take this course?
Biomedical Engineering (or other STEM majors)
Academics with device ideas for sale in the EU
Physicians that have a medical device idea and wish to know how to navigate the EU regulations
Graduate and Undergraduate students whose schools do not offer courses like this one
Regulatory Affairs professionals with 0 to 2 years of experience that need a basic primer on EU medical device regulation
What you get:
- Unlimited time access to 5 recorded online lectures (~ 1 hr of content)
- Access to a medical device forum for discussing/asking questions to the instructor
- Free updates to course material