Training Medical Device Consultant acc. to § 83 MPDG

1st module: Medical device consultant
In the first module, you will work on the meaning, the job description and the required qualification of the medical device consultant in Germany. Relevant terms (including specialist groups) are explained using examples. The focus of the learning unit is on the tasks and duties of the medical device consultant. The module ends with information and recommendations for the company’s internal training concept.

2nd module: Medical device law
The second module begins with an overview of European medical device law. The previously applicable EU directives are mentioned and the new Medical Device Regulation (MDR) is examined in more detail. The Medical Devices EU Adaptation Act is also discussed.

3rd module: Medical devices
In this module, you will learn everything you need to know about the scope of the MDR and the distinction between medical devices and medicinal products. Another focus is on the basic safety and performance requirements. Finally, terms such as custom-made products, series products and accessories are explained.

4th module: Classification
The criteria for classifying medical devices according to risk classes are discussed. Examples with explanations follow.

5th module: Conformity assessment
The fifth module provides you with an overview of conformity assessment. The contents of a declaration of conformity are also discussed.

6th module: Marking of medical devices
This module focuses on the CE mark, graphic symbols for labeling medical devices, the instructions for use, the prohibition of product-related misleading information and the unique device identifier UDI.

7th module: MPBetreibV
The seventh module covers the Medical Devices Operator Ordinance in detail. In particular, it covers instruction, the obligations of operators and users and other requirements.

8th module: Monitoring and reporting system
In this module, you will learn to distinguish between the different forms of market surveillance. You will receive an overview of the internal and external reporting system, the classification of incidents and the procedure for reporting to the competent authority.