Die Themen

• European and German framework in Medical Device Law
• Clinical investigation and clinical trial
• Marketing and distribution of medical devices
• Rights and duties of the competent authorities
• Liability and compliance

Ziele

This intensive course explains in an understandable way the legal framework of the development and marketing of medical devices for non legal practitioners.
You will be familiar with the determining factors for the entire product lifecycle of a medical device:

• Which laws apply to a clinical trial?
• Which forms of advertising are permitted?
• Under which circumstances is the manufacturer liable? And when is the user?

Moreover, two experts will give you advice on the legal innovations of the 4th German Medical Device Act (MPG) and the associated new requirements for manufacturers in Europe.
Furthermore you will be provided with information on the broader significance of the German Federal Institute for Drugs and Medical Devices (BfArM) as the authority for medical devices in Germany.

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