Rights and Responsibilities of the Medical Device Consultant
One-Day Basic Course
The EU Regulations MDR (EU) 2017/745 and IVDR (EU) 2017/746 do not explicitly define requirements for medical device consultants. Does this mean that the role of the Medizinprodukteberater is obsolete?
Certainly not. The position of the medical device advisor is firmly established under German national law, specifically in the Medical Devices Implementation Act (Medizinprodukterecht-Durchführungsgesetz – MPDG), and contributes significantly to the safety and vigilance of medical devices. A comparable legal framework also exists under Austrian law.
According to the MPDG, medical device consultants must demonstrate appropriate expertise. This includes not only regular product training, but also continuous education on the relevant legal and regulatory requirements.
In this interactive one-day seminar, participants will gain an in-depth understanding of the rights and obligations of medical device consultants under the MPDG. You will learn about the specific legal requirements, as well as your responsibilities within the medical device vigilance and reporting system.
- Content
- Legal framework of medical device law in Europe and Germany
- Medical Device Advisor according to § 83 MPDG
- Roles and functions
- Responsibilities and obligations
- Qualification and required expertise
- Sanctions and penalties
- Distinction from the Person Responsible for Regulatory Compliance (PRRC) under Article 15 MDR
- Medical device vigilance and reporting system
- Your Benefits
- Learn the specific duties and qualification requirements for Medical Device Advisor under the MPDG.
- Gain a comprehensive understanding of liability and enforcement provisions.
- Upon successful participation, you will receive a certificate of qualification as a Medical Device Advisor in accordance with § 83 MPDG.
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
- Manufacturers of medical devices and in vitro diagnostic devices
- Medical Device Advisor
- Sales representatives
- Regulatory Affairs professionals
- Service and field staff
- Personnel from related industries seeking to transition into the medical device sector
