Description

Online training "Medizinprodukteberater" according to § 83 MPDG

The event

Online on 4th of March 2025, 9 a.m. – approx. 3 p.m.

Next dates:
-to be announced-

Procedure

After ordering your course access, you will receive an order confirmation.
You will also receive an e-mail before the start of the seminar with a link that you can click on to take part.

Target group

This seminar is aimed at employees of medical technology companies with customer contact, in particular

field service, office staff, marketing/product management
as well as employees of companies that manufacture or import medical devices
sales organisations and medical technology retailers who provide technical information about medical devices and, if necessary, instruct them in their handling.

Basic knowledge in the field of medical devices is required.

In this seminar, you will acquire the necessary expertise to work as a medical device consultant in accordance with the german national law § 83 MPDG. You will learn about the tasks, duties and responsibilities associated with this role. The seminar provides a practical introduction to the legal principles of medical device law, including the Medical Device Regulation (MDR) and the Medical Device Law Implementation Act (MPDG).

We will look at the current status of implementation of the new Medical Device Regulation (MDR), highlight changes and challenges and consider the relevant requirements of Regulations (EU) 2017/745 and 2017/746.

Topic focus

Basics of medical device legislation (including MDR, MPDG, MPEUAnpV, MPAMIV, MPBetreibV)
The new European medical device regulations (MDR and IVDR)
The previous EU directives on medical devices
The Medical Device Law Implementation Act - MPDG
Medical Devices Operator Ordinance - MPBetreibV
Overview of the obligations of medical device manufacturers
Tasks of the person responsible for regulatory requirements (PRRC)
The duties and tasks of medical device consultants
Requirements for the post-market surveillance and vigilance system (MDR, IVDR)
Challenges and current status of implementation
Examples and tips for conversations with customers

Your benefit

You will learn the necessary legal principles of medical device law in a practical way.
They know the tasks, duties and responsibilities of medical device consultants and are familiar with the cooperation with the responsible person according to Art. 15 MDR/IVDR (PRRC).
You will be able to fulfil your obligations in the context of post-marketing surveillance and vigilance.
You will benefit from practical examples that illustrate the implementation of regulatory requirements.
You can advise your customers better and thus contribute to the company's success.
Knowledge of regulatory processes and compliance with them minimises risks for the company and thus supports the long-term success of the company.

Certificate and completion

If desired, the seminar can be concluded with a final test and the certificate “Medizinprodukteberater according to § 83 MPDG”.

You will receive presentation documents and have the opportunity to clarify any questions you may have.

Additional information

Termine	25.02.2025, 26.03.2025, 28.05.2025
Arten	Online-Seminar, Inhouse-Seminar

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Online training “Medizinprodukteberater” according to §83 MPDG

329,00 €

Description