2025-02-22 2025-02-22 , online online, 390 € plus tax Prof. Dr. Stephen Gilbert https://forum-institut.com/seminar/25122537-e-learning-medical-device-advisor-83-mpdg/referenten/25/25_12/25122537-e-learning-medical-device-advisor-83-mpdg_gilbert-stephen.jpg e-learning: Medical Device Advisor §83 MPDG

Our e-learning, specially tailored for medical device advisors, provides you with the essential knowledge to navigate your professional duties confidently and in full legal compliance.

Topics
  • European Medical Device Law and its Application in Germany
  • Definition of a medical device is and how it is brought to market
  • Current Requirements and Tasks of a Medical Device Advisor
  • Vigilance / Market Observation (MD Monitoring and Reporting System)
  • Advertising Medical Devices to Healthcare Professionals


Who should attend
  • Do you advise healthcare professionals about medical devices or in-vitro diagnostics?
  • Does your employer need to demonstrate that you have been trained in accordance with § 83 MPDG?
  • Are you working in internal or external sales?

Then this online training is perfect for you. Acquire the required knowledge step by step - flexibly, at your own pace, and with full control over your schedule.
Aims and objectives
Many medical device manufacturers, especially those with an international presence, have non-German speaking employees who inform or instruct German Healthcare professionals.

In order for the manufacturer to comply with the legal obligation to provide regular training, the Forum Institut offers an English-language e-learning course for medical device advisors.

Our e-learning course provides you with the latest legal requirements for medical device advisors - practical, concise, and flexible, at your own pace.

Upon successful completion of all modules and passing the knowledge assessments, you will receive a qualifying certificate. This certificate allows you to demonstrate your required expertise in accordance with § 83 MPDG to the relevant authority.
Your benefit

After completing this course, you will be optimally prepared:

  • You will understand the regulations for medical devices (MDR and IVDR) and your responsibilities and obligations as a medical device advisor in accordance with § 83 MPDG.
  • Practical tips will simplify the implementation of your reporting and compliance duties.
  • Additional insights will support you in your day-to-day work, particularly when collaborating with healthcare professionals.

e-Learning: Medical Device Advisor (MPDG)

Medical Device Advisor §83 MPDG

e-Learning in 5 modules for non-German speaking employees

Benefits
  • Up-to-date expert knowledge
  • Flexible learning at your own pace
  • Qualifying certificate
  • Practical examples and case studies
  • Official certification according to ISO 9001 and ISO 21001

Webcode 25122537

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JETZT Buchen

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Everything at a glance

Appointment

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Your contact

Verena Planitz
Conference Manager

+49 6221 500-655
v.planitz@forum-institut.de

Details

Our e-learning, specially tailored for medical device advisors, provides you with the essential knowledge to navigate your professional duties confidently and in full legal compliance.

Topics

  • European Medical Device Law and its Application in Germany
  • Definition of a medical device is and how it is brought to market
  • Current Requirements and Tasks of a Medical Device Advisor
  • Vigilance / Market Observation (MD Monitoring and Reporting System)
  • Advertising Medical Devices to Healthcare Professionals


Who should attend
  • Do you advise healthcare professionals about medical devices or in-vitro diagnostics?
  • Does your employer need to demonstrate that you have been trained in accordance with § 83 MPDG?
  • Are you working in internal or external sales?

Then this online training is perfect for you. Acquire the required knowledge step by step - flexibly, at your own pace, and with full control over your schedule.

Aims and objectives

Many medical device manufacturers, especially those with an international presence, have non-German speaking employees who inform or instruct German Healthcare professionals.

In order for the manufacturer to comply with the legal obligation to provide regular training, the Forum Institut offers an English-language e-learning course for medical device advisors.

Our e-learning course provides you with the latest legal requirements for medical device advisors - practical, concise, and flexible, at your own pace.

Upon successful completion of all modules and passing the knowledge assessments, you will receive a qualifying certificate. This certificate allows you to demonstrate your required expertise in accordance with § 83 MPDG to the relevant authority.

Your benefit

After completing this course, you will be optimally prepared:

  • You will understand the regulations for medical devices (MDR and IVDR) and your responsibilities and obligations as a medical device advisor in accordance with § 83 MPDG.
  • Practical tips will simplify the implementation of your reporting and compliance duties.
  • Additional insights will support you in your day-to-day work, particularly when collaborating with healthcare professionals.

Detailed programme

online

Robert Lindner, Esq., MLB, MHA

Module 1: European Medical Device Law and its Application in Germany
  • General Overview of Law in Europe
  • General Overview of Law in Medical Device Laws in Germany
  • Database for Medical Devices in Germany
  • MDCG Guidances and ISO Standards for EU Regulatory Compliance

Prof. Dr. Stephen Gilbert

Module 2: Definition of a medical device is and how it is brought to market
  • Definition of medical device and in vitro diagnostic medical device
  • Path to CE Marking
  • Intended Purpose
  • Classification (Class I - Class III)
  • Technical Documentation
  • Clinical Evaluation and Clinical Investigation
  • Risk Management
  • Design, Verification and Validation
  • Conformity assessment procedure and declaration of conformity
  • Product Documentation

Prof. Dr. Stephen Gilbert

Module 3: Current Requirements and Tasks of a Medical Device Advisor
  • How do I become a Medical Device Advisor?
  • Qualification of a Medical Device Advisor
  • Tasks, Responsibilities and Obligations of a Medical Device Advisor
  • Collaboration with Third Parties
  • Sanctions and Liability

Prof. Dr. Stephen Gilbert

Module 4: Vigilance / Market Observation (MD Monitoring and Reporting System)
  • Basics of the Vigilance System
  • Higher Federal Authorities and Competent Authorities
  • The Obligation to Report

Robert Lindner, Esq., MLB, MHA

Module 5: Advertising Medical Devices to Healthcare Professionals
  • EU Laws Relating to Advertising of Medical Devices
  • German Law Overview on Medical Device Advertising
  • Anti-Corruption Provisions
  • Advertising to Healthcare Professionals and Providers
  • Online Advertising
  • Recommendations for PRRCs and Companies

FAQs

Our e-learning concept in details

The FORUM Institute offers a flexible form of further training with high-quality e-learning courses on various topics. You can access the best know-how from anywhere.

You book an e-learning course which consists of several interactive learning modules. Our e-learning stands out through a combination of text elements, graphics, videos, audio tracks, and quiz questions. The multimedia design ensures a varied and engaging presentation of the content, going beyond plain text to create a comprehensive, multi-dimensional learning experience.

Each module is self-contained. Upon completion of all modules and successful performance in the learning assessments, participants will receive a qualifying certificate.

How exactly does it work?


  • 1. You book the e-learning course on our website.
  • 2. You will receive an e-mail with your login details for our customer portal and will be redirected to the learning platform from there.
  • 3. You start individually with your learning modules.
  • 4. You complete the respective modules with a learning success check.
  • 5. After successfully completing all modules, you will receive a certificate that you can print out at your convenience.

Test the DEMO version of our e-learning free of charge and get an insight into our learning world!

What is a Medical Device Advisor?

A medical device advisor is a person who professionally informs healthcare professionals about medical devices or instructs them in their proper use. According to Section 83 of the Medical Devices Implementation Act (MPDG), such an activity may only be carried out if the consultant has the expertise and experience required for the respective medical devices to provide information and, if necessary, to instruct in the handling of the respective medical devices.

Who is allowed to work as a Medical Device Advisor?

Anyone who

1. has successfully completed education in a scientific, medical, technical or IT-commercial profession and has been trained in relation to the respective medical devices or

2. has acquired experience in providing information on the medical devices in question and, where necessary, in instructing them in their use, by working for at least one year, which may be shorter in justified cases.

The medical devices advisor must keep up to date with the latest state of knowledge about the respective medical devices in order to be able to give expert advice. In addition, he or she must prove expertise to the competent authority upon request. Regular training is therefore required.

Our e-learning provides you with the information you need for your day-to-day work. With our certificate, you have the necessary proof for the medical device advisor according to 83 MPDG.

How is the e-learning structured and how long does it take?

The e-learning course "Medical Device Advisor § 83 MPDG" consists of five learning modules that combine text elements, graphics, videos, audio tracks, and quiz questions. The multimedia design ensures a varied and engaging presentation of the content, going beyond plain text to create a comprehensive, multi-dimensional learning experience.
The corresponding presentation materials can be downloaded.

Each learning module lasts approximately 15 to 50 minutes and concludes with a knowledge check. Every module is self-contained and can be completed individually as often as you like within 90 days. Once all modules have been completed and all knowledge checks successfully passed, a qualifying certificate will be issued.

The entire training takes an average of 125 minutes, plus the time required for the knowledge checks.

Please note: The total duration of the e-learning course may vary significantly depending on your individual reading speed and learning pace.

Is there an exam? How do you receive your certificate?

At the end of each module, a knowledge check is conducted in the form of an online test. Each test consists of 6 to 8 questions (single or multiple choice), of which 75% must be answered correctly to pass.

Once you have passed all modules and the quiz, you will receive a qualifying certificate as a "Medical Device Advisor § 83 MPDG", issued by the FORUM Institut für Management.

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We are now officially certified to ISO 9001 and ISO 21001 standard.

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Discover our e-learning options for medical device advisors in accordance with § 83 MPDG

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Testimonials

- It is very structured & legitimate, every country must implement this - keep the good work - very good learning module - Nice and informative lectures - This e-Learning programme provided a comprehensive understanding of the various aspects of MPDG. I liked that it covered all the main points in relation to the medical device regulation and got to know the overall working of medical devices industry - I like your questiones and answers patterns. I was easy to understand. Modulus are good - E learning programme is good - Good - it was good - Good - All good

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