Medical device advisors (MPB, Medizinprodukteberater) are the information interface between the market and manufacturers.
The MPDG (Medical Devices Implementation Act) regulates the MPB in § 83:
Anyone who professionally provides specialist circles with technical information or instructs them in the proper handling of medical devices (medical device advisor) may only carry out this activity if they have the expertise and experience required for the respective medical devices for the information and, if necessary, for the instruction in the handling of the respective medical devices. This also applies to providing information by telephone.
The expertise is possessed by anyone who
1. has successfully completed training in a scientific, medical, technical or IT commercial profession and has been trained in the respective medical devices or
2. has acquired experience in the provision of information on the medical devices in question and, where necessary, in instruction in their use, by working for at least one year, which may be shorter in justified cases.
The medical device adviser shall provide evidence of his expertise to the competent authority upon request.
They shall keep abreast of the latest knowledge about the medical devices in question in order to be able to give expert advice. Medical device advisors must receive regular training on the products and the regulatory requirements.
Duties of the medical device advisor :
The medical device advisor must receive information from healthcare professionals about adverse reactions, mutual influences, malfunctions, technical defects, contraindications or other risks associated with medical devices and must medical devices and immediately transmit them in writing or electronically to the manufacturer, his authorised representative or their person responsible for compliance with the regulatory requirements.
The medical device advisor shall report any information from healthcare professionals on adverse reactions, effects, interacting influences, malfunctions, technical defects, contraindications or other risks with regard to medical devices immediately. They shall transmit them without delay in writing or electronically to the manufacturer, their authorised representative or their person responsible for compliance with the regulatory requirements.
Do you inform specialist circles, do you distribute products, do you carry out instruction or maintenance? BEO BERLIN will ensure your are ready for the diverse and responsible tasks.
