Understanding and applying basic regulatory knowledge
- Basic course for regulatory requirements for medical device advisor
- Extensive know-how from experts in the field
The medical device industry is, on the one hand, very diverse, but on the other hand, characterized by structured quality management and precise preparation for product approval. At en.co.tec, we prepare you for your role as a medical device advisor, keep you up to date on new developments, and refresh information together with you.
Regulatory expertise is indispensable in the medical device industry, which is why continuous training and education for medical device consultants is essential. That’s why we offer in-house training for your company, where we can address your products specifically in our examples!
Our trainings for medical device advisor
We know that a good medical device consultant not only has an overview of a wide range of products on the market, but also possesses extensive medical and technical expertise in order to provide advice on the products. In consulting for medical products, you serve as the direct link between suppliers, professionals, and users. Because of this, you must also become familiar with and understand both backgrounds and perspectives.
In our trainings, you will learn all about medical devices from experienced industry experts. Questions and suggestions are not only allowed, but even encouraged—we prepare you in the best possible way for your work as a medical device consultant.
To enable product-specific and targeted training, we offer this topic exclusively as an in-house seminar.
Medical device consultants are especially relevant roles because they ensure the safety of products from the medical sector for users. This position is rooted in national law for Austria and Germany—in these countries, a medical device consultant is even required by law.
In summary, medical device consultants are persons who, according to the Austrian Medical Devices Act (Ö-MPG), inform certain medical and technical professionals and instruct them in the proper handling of the products. The mentioned professional groups include, for example, doctors, nursing staff, service technicians, and many others. Patients are excluded.
Das bedeutet Medizinprodukteberater arbeiten hauptsächlich im Außendienst. Eine der Aufgaben besteht darin, den Fachkräften zu zeigen, wie technische und medizinische Produkte vorbereitet werden und was die Nachbereitung umfasst. Durchaus ist es deshalb möglich, dass Medizinprodukteberater im OP unterweisen, aber auch im Innendienst für telefonische Anliegen zu erreichen sind.
The main tasks of a medical device consultant according to the German Medical Devices Act (MPG) can be summarized as follows:
- Explain, advise on, and inform about medical and technical products
- Ensure safe handling
- Provide information when onboarding
- Identify, detect, and report risks associated with medical products
The main areas of responsibility for a medical device consultant include:
The areas of responsibility of a consultant can be diverse, but generally fall into several subcategories. On the one hand, they are responsible for communication between the manufacturer and professionals; on the other hand, they also report possible problems and complaints regarding the medical device to the PRRC (Person Responsible for Regulatory Compliance) and back to the manufacturers.
In summary, these three areas of responsibility belong to the role of a medical device consultant:
The instruction
The medical device consultant instructs professionals on the medical device according to the manufacturer’s specifications. Here, a distinction is made between products that require instruction and those that do not. Defibrillators, MRI machines, and similar devices, for example, require instruction. In these cases, not only professionals but also all users of the product must be instructed.
The training
Strictly speaking, training on medical devices is part of the instruction process. Instructions are often accompanied by training sessions. Depending on the medical device, various topics—such as application or reporting obligations—are the focus here.
The feedback
A very important aspect is the feedback on the effects of medical devices. According to the law, the consultant is required to provide feedback and must report side effects, malfunctions, defects, and more to the PRRC (Person Responsible for Regulatory Compliance). The following questions are essential according to the law: What? To whom? When? In what form? Due to this reporting obligation, medical device consultants make a significant contribution to the safety of products in the medical sector.
What knowledge is required of a medical device advisor?
As mentioned above, consultants are required to have a wide range of knowledge in various areas. The German Medical Devices Implementation Act (MPDG) explicitly specifies the requirement for the position of a medical device advisor – both expertise and feedback are required. The MPDG defines in detail what is meant by expertise and who qualifies for this position. The Austrian Medical Devices Act (Ö-MPG) also sets requirements regarding the expertise of advisors, as well as training, related obligations, and much more.
The EU regulations MDR and IVDR do not explicitly require this position—however, post-market surveillance is all the more important. Similarly, the ISO 13485 standard does not describe the position of a medical device advisor. Nevertheless, regulatory requirements must still be defined and implemented here (for example, the MPG, MPDG, or Ö-MPG, which do explicitly require the position of a medical device advisor).
In summary, it can be said that the role of a medical device advisor is indispensable under medical device law, especially in Austria and Germany, and that these consultants must possess medical and technical knowledge of the individual products as well as regulatory requirements and safety regulations.
Do you want to further your education in your position as a medical device advisor?
At en.co.tec, we offer the basic course: Medical Device Advisor– Regulatory Requirements according to the Medical Devices Act (MPG), which gives you the opportunity to acquire the necessary basic regulatory knowledge as a medical device consultant.
We offer this course as an in-house seminar and are happy to work with you to plan a company-specific seminar! Please feel free to contact us if you have any questions!
We have already had the opportunity to work with many companies and experts from Austria, Germany, and internationally, and to provide further training to a wide range of people from the medical device industry—here you will find an overview of our references:
We are happy to assist you if you want to further your education or have questions about laws or regulatory requirements for medical devices – We are your point of contact for the medical device industry! Benefit from the knowledge of our consultants and get in touch with us.
Do you want to expand your knowledge and successfully learn and implement the requirements related to medical devices? Take a look at our event calendar and book your spot at one of our trainings today—we look forward to seeing you!
