The Compact Seminar “MDR Expert – TÜV” offers comprehensive training on the implementation of the EU Regulation 2017/745 (MDR). You will learn the regulatory requirements of the MDR and understand the changes your company needs to implement.

At the start, you receive an overview of MDR requirements. Building on that, you will learn how to adapt your Quality Management System (QMS) to ensure that internal and external processes are compliant with MDR.
The Post-Market Surveillance (PMS) system becomes a key element of your process landscape, closely linked with PMCF and clinical evaluation. The UDI requirements introduced by the MDR are now mandatory for medical device manufacturers in the EU. You will gain knowledge about responsibilities and obligations for implementing UDI, including European specifics.
EUDAMED, the European database for medical devices, is also covered, including registration requirements.A central topic of the seminar is the role of the Person Responsible for Regulatory Compliance (PRRC) according to Article 15 MDR. You will learn about their tasks and how to manage communication with and from the PRRC within your company.
After successfully passing the exam, you will receive the “MDR Expert – TÜV” certificate, demonstrating your qualification according to the latest medical device regulatory requirements.
Additionally, as the course covers the requirements for the “Person Responsible for Regulatory Compliance (PRRC)” under Article 15 MDR, you will also obtain the corresponding certificate.