The German and Austrian Medical Devices Act MPG require the role of the Medical Device Consultant (also called Medical Device Advisor, or Medizinprodukteberater) and the Safety Officer.
The German MPDG (Medical Devices Implementation Act), the successor to the MPG continues to require the role of the Medical Device Consultant. The Safety Officer is replaced by the PRRC (Person responsible for regulatory compliance) required by the MDR / IVDR.
The seminar enables participants to fulfil their role as Medical Device Consultant and to ensure that they comply with all relevant legal requirements. They
- ...understand the legal basics and how medical devices are regulated in Europe.
- ...know the changes of the MPDG in comparison to the MPG.
- ... know all legal requirements for Medical Device Consultants (and Safety Officers)
- ... know the tasks and duties of Medical Device Consultants and how the roles MPB and safety officer (or PRRC) interact.
- ... know what serious incidents are and that they must be reported without delay.
- ... know what to take into account when advising and selling medical devices.
Practical exercises as an integral part of the seminar guarantee the success of the training. An optional final written exam certifies this success. In any case, participants receive a certificate of participation.
In just half a day, ISO 13485 lead auditor Alexander Thern will provide you with all this knowledge. He introduces you to the world of medical device legislation (in particular MPG §§30 and 31 as well as MPDG §83) and shows you in a very practical way how to meet these legal requirements without unnecessary effort.
The focus is on the following topics in particular:
- Current legal basics: MDR 2017/745, Directive 98/79 EEC, MPG and MPDG, and ordinances (e.g. MPSV, Betreiberverordnung)
- Changes through the Medical Devices Implementation Act (MPDG) and through the MDR 2017/745
- Legal requirements for Medical Device Consultants (and Safety Officers) by MPG and MPDG.
- Conformity assessment procedures: Classification rules, CE marking, Labelling
- Post Market surveillance: monitoring and reporting system, reporting of serious incidents
1:00 PM - 1:30 PM
Introduction, introduction of participants
1:30 PM - 3:00 PM
3:00 PM - 3:15 PM
3:15 PM - 4:45 PM
Tasks and duties of the Medical Device Consultant
4:45 PM - 5:00 PM
Final test and end of the seminar
The seminar "Medical Device Consultant MPDG" is primarily aimed at persons,
- who work for medical device manufacturers or in the sales of medical devices,
- who already have the role of a Medical Device Consultant and want to update their knowledge of the new laws,
- who wish to train as a Medical Device Consultant MPDG.
The seminar meets the requirements of BVMed for training as a Medical Device Consultant.
Alexander Thern is lead auditor for MDD 93/42, ISO 13485, MDSAP and MDR. For the Johner Institute he is the trainer for "Internal Auditor" and "Medical Device Consultant and Safety Officer" since many years. He shares the common vision of lean QM systems that contribute to real quality improvement and more cost-effective development and production. Alexander Thern looks back on many years of consulting and auditing practice. He has been working for the Johner Institute since 2010. Alexander has lived in England and speaks fluent (British) English.