e-Learning: Medical Device Advisor §83 MPDG
e-Learning in 5 modules for non-German speaking employees
- 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

e-Learning
Ab
390,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 390,-€ zzgl. MwSt.
Your personal single-user account is valid for 90 days from the date you receive your login details. During this period, you can revisit the modules as often as you like. Upon successful completion, you will receive a personalised, qualifying certificate. The participation fee includes all accompanying materials, further information, links, and templates. All materials are available for download.
Buchungsdetails
e-Learning
Ab
390,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 390,-€ zzgl. MwSt.
Your personal single-user account is valid for 90 days from the date you receive your login details. During this period, you can revisit the modules as often as you like. Upon successful completion, you will receive a personalised, qualifying certificate. The participation fee includes all accompanying materials, further information, links, and templates. All materials are available for download.
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.
Your speakers
What to Expect
- 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.
Objective of the Event
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 for medical device advisors.
Our e-Learning 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.
The certificate and assessments are generated on the basis of an automated, non-individual multiple-choice test.
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.
Programme
online
Robert Lindner, Esq., MLB, MHA
- 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
- 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
- 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
- Basics of the Vigilance System
- Higher Federal Authorities and Competent Authorities
- The Obligation to Report
Robert Lindner, Esq., MLB, MHA
- 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
Module 1: European Medical Device Law and its Application in Germany
Module 1: European Medical Device Law and its Application in Germany
Robert Lindner, Esq., MLB, MHA
- 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
Module 2: Definition of a medical device is and how it is brought to market
Module 2: Definition of a medical device is and how it is brought to market
Prof. Dr. Stephen Gilbert
- 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
Module 3: Current Requirements and Tasks of a Medical Device Advisor
Module 3: Current Requirements and Tasks of a Medical Device Advisor
Prof. Dr. Stephen Gilbert
- 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
Module 4: Vigilance / Market Observation (MD Monitoring and Reporting System)
Module 4: Vigilance / Market Observation (MD Monitoring and Reporting System)
Prof. Dr. Stephen Gilbert
- Basics of the Vigilance System
- Higher Federal Authorities and Competent Authorities
- The Obligation to Report
Module 5: Advertising Medical Devices to Healthcare Professionals
Module 5: Advertising Medical Devices to Healthcare Professionals
Robert Lindner, Esq., MLB, MHA
- 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
Learning Nugget
Downloads
Request the documents using our form.

Brochure

Abbreviations-Medical-Devices
Further Informations
Training for the World of Tomorrow
The FORUM Institute offers a flexible form of professional development with high-quality e-learning programmes across various subject areas. You can access the best expertise from anywhere.
You book an e-learning programme consisting of several didactically structured learning modules. The main component of our e-learnings is video content in which experts share their knowledge on the respective topic. The e-learnings also include supplementary materials such as additional documents, links, case studies or checklists. Many e-learning modules are designed to be interactive, featuring learning tasks and exercises. This gives you the opportunity to actively engage and deepen your newly acquired knowledge in practice.
Each learning module concludes with a learning success assessment. Once you have completed all modules and passed the assessments, you will receive a qualifying certificate that you can conveniently print out. The certificate and assessments are generated on the basis of an automated, non-individual multiple-choice test.
How does it work exactly?
1. You book an e-learning programme on our website
2. You receive an email with your login details for our learning platform
3. You log in to our learning platform using these credentials
4. You start the learning modules at your own pace
5. You complete each module with a learning success assessment
6. After successful completion, you receive a certificate that you can conveniently print out
Try out the DEMO versions of our e-learnings for free and get a first impression of our learning environment!
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.
The certificate and assessments are generated on the basis of an automated, non-individual multiple-choice test.
Customer Testimonials
What satisfied participants say
Our Recommendations
Marketing für Medizinprodukte im Selbstzahlermarkt
In diesem Praxisseminar lernen Sie, wie Sie Consumer-Medizinprodukte strategisch im Spannungsfeld zwischen Fach- und Laienkommunikation positionieren - ob mit oder ohne Erstattung. Sie erfahren, wie…Sprache: Deutsch
Early Phase Complex Clinical Trials
Do you want to strategically plan your early phase clinical trials (phase I/IIa) from the start to accelerate drug development? Then get tips and hands-on experience regarding traditional and complex…Sprache: Englisch
Global variations and lifecycle management
Global variations and lifecycle management - covering key regions: USA, Asia (China, Japan, South Korea), LATAM (Central America, Brazil), and Gulf Cooperation Council (GCC). Take this opportunity to…Sprache: Englisch
Clinical Strategy China (NMPA)
This seminar equips medical device professionals with a clear regulatory and operational roadmap for clinical evaluation and clinical investigations under China's NMPA framework. Building on existing…Sprache: Englisch
Marketing Authorisation in Latin America
An interactive online seminar to explore real regulatory cases and challenges in marketing authorisation and lifecycle management across Mexico, Argentina, Colombia, Peru, Chile and Brazil - led by…Sprache: Englisch
Further Information
Your Contact Person
We are happy to advise you personally and individually.

Verena Planitz
Conference Manager
+49 6221 500-655
v.planitz@forum-institut.de




