Online Course: European Medical Device Regulation for Economic Operators
A fundamental revision of Medical Device Directive 93/42/EEC has taken place to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health. The new Medical Device Regulation 745/2017 have increased obligations for all the economic operators: manufacture, authorised representative, importer and distributor.
Why you should join the online course
- To learn about when a device is considered as a medical device and routes to compliance
- To have an overview of your obligations as manufacture of medical devices to European Market
- To be aware of your obligations when importing medical devices to European Market
- To know your obligations when you are distributing medical devices on the European Market
- To get a certificate that proves your new learning
What you will learn
You will learn about the regulatory landscape and when a device is considered as a medical device.
You will learn about the obligations that each of the economic operators have in relation to the medical device regulation. Even if your company does not have the role of being manufacture, there might be important information/learning s in these parts to fully understand your obligations.
The course is split into 4 parts:
- Introduction to the regulation
- Manufacture obligations - part 1
- Manufacture obligations - part 2
- Authorised Representative, Importer and Distributor obligations
Who should join
Anyone who would like to learn about medical device regulation 745/2017 and the obligations for each economic operators: manufacture, authorised representative, importer and distributor.
Need of prior knowledge/experience
You do not need any prior knowledge or experience.
E-learning by computer or tablet with a loudspeaker.
Online test including certificate when having at least 80% correct answers.
Length of course
1 hour and 40 minutes excluding the test
You can access the course anytime you want during a period of 3 months starting from the time that you receive your user-id and password.
Hands-out can be down-loaded within the same period of time.