MDR Expert Compact Seminar – TÜV - English
Our 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.
Medical Device Regulation (MDR) in Detail
Fundamentals and content of the MDR, including device classificationImplementing MDR Requirements in a Quality Management System (QMS)
Essential elements of an MDR-compliant QMSPost-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF)
New MDR requirements for PMS/PMCF and their practical implementationEUDAMED (European Database on Medical Devices)
Understanding and fulfilling EUDAMED requirements; secure handling of dataPerson Responsible for Regulatory Compliance (PRRC) – Article 15 MDR
Role, requirements, and scope of responsibilitiesFinal Examination
Gain a deep understanding of MDR regulatory requirements and their practical implications for your company.
Learn how to implement MDR requirements within your QMS and ensure compliant processes.
Understand Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF), UDI, and EUDAMED requirements.
Learn about the role, tasks, and responsibilities of the PRRC (Article 15 MDR).
Strengthen your qualification and support your company’s MDR certification.
Regulatory Affairs Managers, Quality Managers, Heads of R&D, Safety Officers/PRRCs, CEOs, Importers, Distributors, Authorized Representatives, Medical Device Consultants, and Regulatory Authorities.
The seminar fee includes the textbooks:
“Medical Device Regulation (MDR)” or “In-Vitro Diagnostic Regulation (IVDR)”
“UDI – Unique Device Identification”
The final examination takes place on the last day of the course.
TÜV SÜD Academy Certificate: MDR Expert – TÜV and Person Responsible for Regulatory Compliance (PRRC)
This training is being operated by TÜV SÜD Akademie GmbH in Germany. The General Terms and Conditions as well as the Privacy Notice of TÜV SÜD Akademie GmbH apply. In case of any questions, do not hesitate to contact us.