Rights and Responsibilities of the Medical DeviceAdvisor
The EU regulations MDR and IVDR do not contain any requirements for medical device advisors. Does this mean that the medical device advisor is unnecessary?
No, because the medical device consultant is enshrined in German national law (Medical Device Act Implementation Act, MPDG) and is intended to contribute to the safety of medical devices. This concept is also enshrined in Austrian law.
The MPDG requires medical device consultants to possess the necessary expertise. This means that, in addition to regular product training, the legal fundamentals must also be taught or refreshed at regular intervals.
In this interactive seminar, the specific rights and obligations will be presented. You will learn about the MPDG’s requirements for medical device advisors and understand what you need to keep in mind regarding the medical device vigilance and reporting system.
- Content
- Legal Requirements of Medical Device Law in Europe and Germany
- Medical Device Advisors under Section 83 of the Medical Devices Act (MPDG)
- Functions
- Duties and Responsibilities
- Qualifications and Expertise
- Penalties
- Differences from the Person Responsible for Regulatory Compliance, MDR Article 15
- Medical Device Vigilance and Reporting
- Your Benefits
- You will learn about the various responsibilities and requirements for medical device advisors.
- You will gain a comprehensive overview of liability and penalty issues.
- The certificate serves as proof of your qualification as a medical device advisor.
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
- Manufacturers of medical devices and in vitro diagnostic devices
- Medical device consultants
- Sales representatives
- Regulatory affairs professionals
- Service staff
- Field sales representatives
- Professionals transitioning from other industries
