Seminar "Medical Device Consultant MPDG"

The seminar covers the following topics: 

• Introduction and comparison of the old and new legal systems 
  • Old legal system: 
    • EU: MDD, AIMDD, IVDD 
    • DE: MPG, MPV, MPBetreibV, MPSV 
  • New legal system: 
    • EU: MDR, IVDR 
    • DE: MPAnpGV, MPDG, MPBetreibV, MPAMIV 
• Relationship between laws, directives, regulations, standards, general (safety and performance) requirements 
• Changes in requirements under the new legal system 
  • Classification of medical devices 
  • Conformity assessment procedures 
  • Requirements for economic operators 
  • Person Responsible for Regulatory Compliance (PRRC) (Art. 15 MDR/IVDR) 
• General introduction to the MPDG 
• §83 MPDG: Medical device consultant 
  • Expertise of medical device consultants 
  • Qualification requirements 
  • Tasks and duties of the medical device consultant role 
• Market surveillance and post-market surveillance 
  • Cooperation with the PRRC

After the seminar, you will know:   

• the requirements of the MDR/IVDR 
• the detailed tasks and duties of a medical device consultant 
• the qualification requirements for the role of medical device consultant 
• the organizational interfaces with regard to the recording and reporting of incidents involving medical devices 

This seminar is designed for: 

• people who professionally inform users from specialist circles about medical devices 
• people who professionally instruct users from specialist circles in the handling of medical devices 
• people who professionally record incidents involving medical devices and forward them for further processing 

Knowledge of the regulatory requirements of the MDR and IVDR is helpful. 

However, participants can also attend this seminar without detailed prior knowledge; it includes a brief introduction to the regulatory basics. 

An understanding of your own medical devices is also helpful. 

After registering, you will receive a confirmation email containing the meeting link, the time, and information about the participants.  

An invoice will be sent to you within the next 48 hours, with a payment term of 14 days. If this payment term is not feasible for your company, please send a short e-mail to [email protected] to find a solution.  

Three days before our online seminars and workshops, you will receive two e-mails: The first contains the final link to the seminar and the second contains the access data to a cloud folder in which you will find documents for preparation, exercises, and presentations.   

If the seminar or workshop takes place in person, you will also receive the access link to your seminar documents three days before the date of the event. We will also provide documents in digital form for in-person events. 

The seminar takes place either in person or online.  

Our online/remote seminars and workshops are conducted via the video conferencing tool MS Teams. We recommend dialing in 20 minutes before the seminar begins so that any technical problems can be resolved in good time. If you have any questions or encounter any issues, our team is always available to help. 

We also recommend that you arrive at the seminar room approximately 20 minutes before the start of the face-to-face events.

At the end of the seminar, you will receive a feedback link for evaluation. The following day, we will send you your certificate of attendance.

If you experience technical problems while participating or have any other questions, you can contact our support team anytime, even at short notice. The documents provided also include an emergency number to help you in urgent cases. 

Our general FAQ section answers further technical and organizational questions.