Training Medical Device Consultant acc. to § 83 MPDG

Our further training will qualify you optimally for the challenges as a medical device consultant – in accordance with the Medical Device Law Implementation Act (MPDG).

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Schulung zum Medizinprodukteberater auf ENGLISCH

The essential basics in a nutshell

Know and implement legal requirements

Employees who dispense medical devices must be able to prove that they are qualified medical device consultants and ensure that the medical device does not pose a risk to the patient or third parties. The requirements to be met for this are set out in § 83 of the MPDG.

This online training course provides the knowledge and methods required for medical device consultants in a compact and understandable way.

4-6 hours

The course is divided into 8 modules. Depending on your previous knowledge, you will need a maximum of 6 hours.

Access anytime

The online course is a self-study course. This means that you can join the course at any time and take individual breaks.

Certificate

With the certificate you fulfill the requirements of the MPDG for further training as a medical device consultant.

279,00 EUR

plus VAT. Usually 310,00 EUR . With more than 10 participants you benefit from special conditions.

Complete further training to become a medical device consultant at your own pace

Acquire the required qualification

Target group: Employees of medical device manufacturers, sales organizations of the medical technology trade (distributors, importers) who provide technical information about medical devices and, if necessary, instruct in their handling

Prerequisites: The requirements for working as a medical device consultant are defined in Section 83 (2) of the Medical Device Law Implementation Act (MPDG).

Course type: Online self-study course

The appointment of medical device consultants is a special feature of German legislation, which aims to improve and ensure user and patient protection with this regulation. Medical device consultants have a high level of responsibility towards users and specialist circles and, with their specialist knowledge, make a decisive contribution to ensuring that the therapeutic objective is achieved when using a medical device.

Acquire the necessary qualification with Trautmann training courses.

Contents and process

Course structure

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.

Lively mix of methods with specific examples

Extract from the training documents

What our customers say

Feedback from our course participants

"Die richtigen und neuesten rechtlichen Informationen zum Medizinprodukteberater zu finden habe ich mich immer schwer getan. Daher hatte ich mich dazu entschlossen, das Konzept von Trautmann zu nutzen und auch meinen Teampartnern anzubieten
Dank des übersichtlichen und aufs Wesentliche konzentrierten Aufbaus des Online-Kurses ist es mir leicht gefallen, den Kurs zu absolvieren und natürlich auch zu bestehen
Als rechtliche Grundlage beim Vertrieb eines Medizinproduktes ist dieser Kurs für mich ein Muss."

Birgit Bieg

"Wir haben mit unserem Außendienst-Team die Flexibilität des Online-Kurses genutzt. Dadurch konnte jeder seine Zeit selbst einplanen. Aufbau und Handling der einzelnen Module waren übersichtlich und gut verständlich. Durch die Tests nach den Modulen wurde man auch bei zeitlich versetzter Bearbeitung noch mal wieder an die Inhalte erinnert. Das Team hatte keine Probleme die Zertifikate zu erlangen."

Kinova Europe GmbH

"Auf der Suche nach einer möglichst flexiblen Lösung für die Ausbildung unserer Mitarbeiter zum Medizinprodukteberater nach§ 83 MPDG sind wir hier fündig geworden. Die ausgezeichnete und sehr freundliche Beratung, die Flexibilität und das sehr gute Preis-/Leistungsverhältnis hat uns überzeugt. Die Module sind sehr benutzerfreundlich aufgebaut und wir hatten bisher keine Probleme auf dem Weg zu notwendigen Zertifikaten.
Wir danken für die ausgezeichnete Zusammenarbeit und können das Unternehmen absolut weiterempfehlen."
Zufriedener Trautmann-Kunde

HMS GmbH

Flexibility during learning

Online seminar

There are fewer and fewer resources available for further training on the job. Time in particular is at a premium, which means that further training courses must be easy to integrate into everyday working life. Online training courses, which can be carried out individually anywhere and at any time, are therefore a good alternative to a traditional face-to-face seminar. We therefore provide you with the medical device consultant training course as a fully-fledged online course, giving you absolute flexibility in terms of further training.

Learn and deepen the necessary knowledge step by step – at your own pace and with individual time management. The online course is completed with the “Medical Devices Consultant acc. to § 83 MPDG” certificate after successful completion of the test. Book the online course “Medical Devices Consultant acc. to § 83 MPDG” directly online now or submit a request for an individual offer for a face-to-face training course if you would prefer to obtain your certificate in a fixed scheduled period with a personal instructor.

Make your booking request via our contact form or book the course directly via PayPal.

Quick and easy registration for the online course

Form

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  • 1. complete and return the form
  • 2. transfer the invoice amount
  • 3. activation and receipt of access data
  • 4. start the course

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Offer

More information
  • Special conditions from 10 participants
  • Save money with subscription
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Frequently asked questions (FAQ)

In our central Frequently Asked Questions (FAQ) section you will find all the answers and the most frequently asked questions on your topic.

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Consulting: +49 34293 4797-20

Courses: +49 34293 4797-27