Medical device consultant (certificate)
Basic seminar according to § 83 MPDG
Employees of medical technology companies with customer contact, especially field service, office service, marketing/product management and service for training medical device advisors,
The training of employees as medical device advisors is required according to § 83 MPDG, if the individuals provide medical professionals with technical information about medical devices or instruct them in the proper handling of such devices.
The requirements, tasks and responsibilities are precisely defined in the Medical Devices Medical Device Law Implementing Act (MPDG). They apply both to permanently employed medical device advisors and to those who work as independent sales representatives in the distribution of medical devices. This includes not only sales representatives, but all employees with customer contact (including in-house sales and service) when they provide information about the company’s products. If a company or the medical device advisor does not meet these requirements, they may face a fine.
The MPDG dictates that medical device advisors must undergo regular training.
In addition to complying with legal requirements, medical device advisors can provide better advice to their customers and thus contribute to the success of the company. Knowledge of regulatory procedures and their compliance reduces risks and thus supports the long-term success of the company.
The medical device advisor training can also be conducted with a focus on in vitro diagnostics (IVDR).
In the in-house seminar, the company’s products can be specifically looked at and sales questions, e.g. on briefing, can be answered.
Focus of topics
- Basics of medical device law
- The new European Medical Device Regulation (MDR) and the previous EU directives on medical devices
- The new Medical Device Law Implementation Act – MPDG
- Medical Device Operator Ordinance – MPBetreibV
- Overview of the obligations of manufacturers of medical devices
- Duties of the safety officer for medical devices/Sicherheitsbeauftragten or, newly, of the person responsible for regulatory requirements
- Duties and tasks of the medical device advisors
Duration of the seminar
approx. 6 hours
The seminar ends with a test (multiple choice). All participants who have passed will receive a certificate „Medical device advisor according to § 83 MPDG“.
1,890.00 Euro + tax + travel expenses if applicable (not applicable for online seminar)
The costs include the material for up to 10 participants.
Request in-house seminar