Medical Device Consultant Training – Quick-Teach

Legal bases for the Medical Device Consultant Training according to the Medical Device Law Implementation Act (Medizinprodukterecht-Durchführungsgesetz, MPDG)*

Let your employees be trained as medical device consultants.
Who is a Medical Device Consultant (MDC)?

• Anyone who professionally informs experts.
• Anyone who instructs in the proper handling of medical devices.
• Anyone who passes on information about medical devices over the phone.

According to the German Law (MPDG), this activity may only be carried out if the necessary expertise and experience is available for the information and, if necessary, for the instruction in the handling of the respective medical devices*.
In this case, expertise means:

• Training in a scientific, medical, technical or IT commercial profession has been successfully completed and training has been provided on the respective Medical Devices or,
• At least one year of work, which in justified cases may be shorter, has been acquired in providing information on the respective Medical Devices and, if necessary, in instructing users on how to use them (e.g. intern, trainee) and must be trained regularly.

The Medical Device Consultant must be able to present proof of training at the request of the authorities!

The legal basis is MPDG § 83. When interpreting the legal requirements cited above, it is important to note that, first and foremost, employees (field staff or possibly office staff) must have knowledge of the respective Medical Devices. In the training courses offered, we only cover the regulatory part, which consists of the Vigilance System fo Medical Devices (Post-Market Surveillance & Monitoring), the basics of Medical Devices and the interface to the Person responsible for regulatory compliance (PRRC) and as an essential part: The Medical Device Consultant must record reports from healthcare professionals regarding side effects, interactions, malfunctions, technical defects, contraindications or other risks associated with medical devices and must immediately forward them to the manufacturer, its authorized representative or its PRRC in writing or electronically.

Training – Medical Device Consultant

We would be happy to provide you with a non-binding offer for in-house or online training for your Medical Device Consultants. The target group is manufacturers, importers and distributors according to MPDG based in Germany or making products available on the market in Germany. Unfortunately, our engineering firm does not offer individual training. More than 1000 Medical Device Consultants have already completed our training.