MDR Expert Training Course - TÜV Complete Package
Become audit-ready for EU MDR 2017/745 in 5 days
Our five-day advanced MDR Expert Training Course – TÜV SÜD Complete Package offers a focused and comprehensive training for the implementation of EU Regulation 2017/745 MDR. You will gain a clear understanding of the regulatory requirements of the MDR and learn about the changes your company needs to address promptly. To get started, you will be given an overview of the requirements of the Medical Device Regulation (MDR).
The post-market surveillance system becomes a central element of your process map, with important connections to PMCF and clinical evaluation. The new Medical Device Regulation (2017/745) also makes unique device identification requirements mandatory for medical device manufacturers in the European Union. You will gain an understanding of the responsibilities and obligations involved in implementing unique device identification, including aspects specific to Europe.
Another important part is the role of the person responsible for regulatory compliance, or PRRC, according to Article 15 of the MDR. You will learn what this role entails and how to manage communication to and from the PRRC within your company.
By passing the examination, you will demonstrate your knowledge of the latest medical technology regulations and enable your company to bring medical devices to market safely and successfully, even after the MDR comes into force. You will receive your globally recognised TÜV SÜD “MDR Expert” certificate. As the training covers the person responsible according to Article 15 MDR, you will also receive the certificate "Person Responsible for Regulatory Compliance" in accordance with Article 15 MDR.
Does your company need support with MDR? Become their MDR expert by registering today on our next virtual course. Looking for an MDR course for beginners? You can study module 1 of this course separately by booking our 1-day MDR In Detail Training Course.
- Manager Regulatory Affairs, Quality Management Officer, Head of Research & Development, Safety Officer/PRRC
- Managing directors, importers, distributors, medical device consultants, EU representatives, employees in supervisory authorities, consultants
- You prove that you know the regulatory requirements from the MDR and understand the changes that your company has to cope with in a timely manner
- You are able to help ensure that your company makes changes to the QM system in order to map internal and external processes in compliance with MDR
- They are familiar with the post-market surveillance system and the essential requirements for UDI and EUDAMED
- You will find out what activities the person responsible for regulatory compliance ("PRRC") according to Article 15, MDR involves
- The training attendance supports you in proving your professional qualification within the framework of the MDR certification of your company
- Medical Device Regulation (MDR) in detail
- Basics and contents of the Medical Device Regulation (MDR), classification
- Medical Device Regulation (MDR) - Implementing requirements in the quality management system
- Necessary contents of a quality management system compliant with the MDR
- Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) of Medical Devices
- New regulations for PMS/PMCF according to the MDR
- Unique Device Identification (UDI) in detail
- Regulatory requirements for UDI and the implementation of requirements for UDI
- Person Responsible for Regulatory Compliance (PRRC)
- Requirements and scope of the PRRC
Learn about the MDR regulatory requirements and changes your company needs to implement in a timely manner. Be able to participate in the implementation of the changes in your company's QM system in order to map internal and external processes in accordance with the MDR. Become familiar with the system of post-market surveillance as well as the essential requirements for UDI and EUDAMED
- Course delivered by one of TÜV SÜD's leading industry experts
- Small class sizes enhance trainer-delegate relationship
- Receive “MDR-Expert – TÜV” certificate plus a PRRC (Article 15) training certificate.
Upon passing the exam you will receive your globally recognised TÜV SÜD certificate on "MDR-Expert".
What is the MDR Expert Training Course?
The MDR Expert training course is a 5-day advanced programme that provides a comprehensive understanding of EU Regulation 2017/745 (MDR). It covers regulatory requirements, post-market surveillance, UDI obligations, and the role of the PRRC, equipping participants to ensure compliance and successfully bring medical devices to market under the MDR.
TÜV SÜD tests and certifies through its Notified Bodies medical devices and their manufacturers. TÜV SÜD Academy UK offers trainings in the field of medical devices.
The neutrality and independence of the conformity assessment procedures carried out by TÜV SÜD must be maintained. In the interest of our customers, hence the seminars of TÜV SÜD Academy do not contain any product-specific, process-related or company-specific content or solutions that could fulfill the function of individual consulting.
In case of any questions or uncertainties, please do not hesitate to contact us.
Alex Lackey, Compliance Consultant
With a strong background in operations and compliance management, Alex brings over five years of experience in medical device regulatory and standards compliance to TÜV SÜD’s training courses. He began his career in third party logistics and fulfilment, progressing into warehouse and operations management before co founding a logistics company. Since 2020, he has focused on ISO and regulatory support , helping organisations navigate complex compliance requirements.
His expertise includes systems and process management as well as regulatory and standards compliance. He is passionate about supporting businesses of all sizes and sectors in developing effective compliance frameworks. Through his training, participants gain both a clear understanding of regulatory principles and the practical skills needed to apply them successfully in their organisations.