Content
The seminar provides an overview of the applicable laws that apply in this regulated environment.
From a regulatory perspective, what is a medical device and how does it differ from other types of products? What special types of medical devices and what classification are there and what constitutes them? When are medical devices marketable? What requirements does a medical device manufacturer have to meet? What role do the other economic actors (EU representative, importer and dealer) as well as authorities and notified bodies play?
This seminar also addresses the post-marketing phase. What obligations apply to the manufacturer, the dealer and the user? What reporting requirements exist? How should cooperation with doctors and clinics be structured? The liability risks for companies and employees are identified in preparation for the in-depth seminar on “liability”.
Topic overview
- Overview of the legal framework at German and European level
- Definition of the medical device, distinction from medicines and other products
- Special product types (custom-made products, in-house production, accessories)
- Obligations and regulations to be observed when placing medical devices on the market
- Classification and conformity assessment procedures
- Notified Bodies
- Proper labeling of medical devices and instructions for use
- Clinical evaluation and clinical trial
- Requirements for third country manufacturers (including Switzerland, UK)
- After marketing
- Role of the importer/distributor
- Obligations in monitoring medical devices, PMS and PMCF
- Reporting obligations and vigilance
- User and operator rights
- Competent authorities and their tasks, legal protection against authorities
target group
Managing directors and board members, executives and employees of manufacturers, EU representatives, dealers and importers of medical devices as well as medical technology retailers.
Prior knowledge
Introductory course, no previous knowledge required.
Funding opportunity
ESF funding is possible. Further information can be viewed here .
KONTAKT:
Online
