2024-12-30 2024-12-30 , online online, 390 € zzgl. MwSt. Prof. Dr. Stephen Gilbert https://forum-institut.de/seminar/25122544-e-learning-medical-device-advisor-mpdg/referenten/25/25_12/25122544-e-learning-medical-device-advisor-mpdg_gilbert-stephen.jpg e-Learning: Medical Device Advisor (MPDG)

Our e-learning, specially tailored for medical device consultants, 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
  • The MDR and IVDR - an overview of all relevant innovations for medical device advisors
  • What a medical device is and how it is brought to market
  • Current requirements and tasks of medical device advisor
  • Vigilance and market observation


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.
e-Learning for medical device advisors (§ 83 MPDG)
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 at any time.
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 (Medizinprodukteberater)

according to § 83 MPDG:
Training and e-Learning 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 25122544

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Termin

anytime

anytime

Zeitraum

online

online
Veranstaltungsort

online

online

Downloads
Gebühr
Your contact

Verena Planitz
Conference Manager

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

Details

Our e-learning, specially tailored for medical device consultants, 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
  • The MDR and IVDR - an overview of all relevant innovations for medical device advisors
  • What a medical device is and how it is brought to market
  • Current requirements and tasks of medical device advisor
  • Vigilance and market observation


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.

e-Learning for medical device advisors (§ 83 MPDG)

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 at any time.

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
  • Hierarchy of norms
  • Current European legal framework
  • Previous national regulations and what happens to them
  • Standards. What are they?

Prof. Dr. Stephen Gilbert

Module 2: The REGULATIONS (EU) 2017/745 on medical devices and (EU) 2017/746 on in vitro diagnostic medical devices
  • Obligations of economic operators
  • UDI, Eudamed, DMIDS
  • Notified bodies
  • Post-market surveillance (PMS)
  • Practical implications for Medical device manufacturers and advisors
  • PRRC

Prof. Dr. Stephen Gilbert

Module 3: What a medical device is and how it is brought to market
  • Meaning of the CE marking: Purpose, CTS and GSPR
  • Classification
  • Technical and clinical development
  • Validation and verification
  • Product documentation
  • Risk management and risk analysis
  • Product labelling
  • Symbols and marking (DIN EN 980)
  • Declaration of conformity, CE marking

Prof. Dr. Stephen Gilbert

Module 4: Current Requirements and Tasks of Medical Device Advisor
  • Qualification, function and tasksof a medical device consultant
  • Active medical devices according to MPBetreibV and obligation to instruct by manufacturer?
  • Cooperation with and tasks of PRRC
  • Cooperation with health care professionals
  • Obligation to cooperate
  • (Regular) training(s) and obligations of the medical device/IVD manufacturer
  • How to proof your expertise

Robert Lindner, Esq., MLB, MHA

Module 5: Vigilance and Market Observation (Medical Device Monitoring and Reporting System)
  • Basics of the vigilance system
  • Higher federal authorities and competent authorities in Germany
  • What is an incident?
  • Your obligation to report: What, when, how (quickly), where must be reported and who must report?
  • Who is responsible for "false reports" or "not reporting"?
  • Risk management by the competent authorities
  • New reporting obligations in medical devices vigilance (PMS, PSUR, SSCP)

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 didactically prepared learning modules. The main component of our e-learning courses are videos in which experts share their knowledge on the respective subject area with you. The e-learnings also contain supplementary material, such as additional documents, links, practical cases or checklists. Furthermore, the learning modules of many e-learning courses are designed to be interactive with learning tasks and exercises. This gives you the opportunity to become active yourself and to deepen your new knowledge by putting it into practice.

Each learning module ends with a learning success check. Once you have completed all the modules and successfully passed the learning success checks, you will be issued with a qualifying certificate, which you can conveniently print out straight away.

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 consultant according to 83 MPDG.

German "Medizinprodukteberater § 83 MPDG" for English speaking employees

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 to teach the following content:

  • European regulations and the German medical device law
  • What a medical device is and how it is placed on the market
  • Requirements and tasks of medical device advisors
  • Vigilance and market surveillance (monitoring and reporting system)

In-house

We also offer this training as an in-house programme. Feel free to contact us for more information!

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

Our options in German language: Medizinprodukteberater gemäß § 83 MPDG (Basics) and Refresher Medizinprodukteberater ge...

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e-Learning
We guarantee the highest quality

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

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We guarantee the highest quality

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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