MDR Expert Training Program - TÜV Complete Package
Understanding the regulatory requirements of the Medical Device Regulation and implementing them in the company
Master the regulatory landscape of the EU Medical Device Regulation (MDR) 2017/745 with TÜV SÜD’s comprehensive MDR Expert Training Program. Designed for professionals navigating the complexities of medical device compliance, this intensive five-day program equips you with the knowledge and tools to implement MDR requirements effectively within your organization.
From foundational principles to advanced regulatory strategies, this course covers the full spectrum of MDR compliance, including post-market surveillance (PMS), clinical follow-up (PMCF), Unique Device Identification (UDI), and the critical role of the Person Responsible for Regulatory Compliance (PRRC) under Article 15.
Upon successful completion of the final examination, participants will earn the globally recognized TÜV SÜD MDR Expert Certificate, validating your expertise and enhancing your professional credibility.
- Understand and apply the regulatory requirements of MDR 2017/745.
- Identify and implement necessary changes to quality management systems in line with MDR.
- Navigate the requirements for PMS, PMCF, UDI, and EUDAMED.
- Define the responsibilities and communication strategies for the PRRC role.
- Demonstrate professional qualifications for MDR certification processes.
Important: TÜV SÜD tests and certifies through its Notified Bodies medical devices and their manufacturers. TÜV SÜD Akademie GmbH 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 Akademie 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 at [email protected].
This course is ideal for professionals involved in regulatory compliance and quality management, including:
- Regulatory Affairs Managers
- Quality Management Officers
- Heads of R&D
- PRRCs and Safety Officers
- Managing Directors, Importers, Distributors
- EU Representatives, Consultants, and Supervisory Authorities
- Medical Device Regulation (MDR) in detail
- Overview, structure, and classification under MDR 2017/745
- 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 framework and implementation best practices
- Person Responsible for Regulatory Compliance (PRRC)
- Requirements and scope of the PRRC
- Final Examination
- Certification assessment for MDR Expert
Our compact training on "MDR-Expert – TÜV" offers you comprehensive training for the implementation of EU Regulation 2017/745 MDR. You will learn about the regulatory requirements of the MDR and understand the changes that your company must cope with in a timely manner. To get started, you will be given an overview of the requirements of the MDR.
The post-market surveillance system becomes one of the central building blocks of your process map with important interfaces to PMCF and clinical evaluation. The new Medical Devices Regulation (2017/745) also makes UDI requirements mandatory for medical device manufacturers in the EU. You will gain knowledge of the responsibilities and obligations involved in the introduction of UDI, including European specificities.
Another important part of the compact training on the "MDR-Expert – TÜV" is the function of the PRRC, the person responsible for compliance with regulatory requirements according to Article 15 of the MDR. You will learn which activities this function involves and how you can design communication to and from the PRRC in the company.
With successful completion of the examination as "MDR-Expert – TÜV", you prove your knowledge for the latest regulations of medical technology and enable your company to successfully and safely bring medical devices to market even after the MDR comes into force. Since the training content for the "Responsible Person according to Article 15 MDR" is included, you will also receive the certificate "Person Responsible for Regulatory Compliance (PRRC)" according to Article 15 MDR.
If this course doesn't suit your needs, it may interest you to know that we also deliver module 1 of this course individually, MDR In Detail Training Course.
- Expert Instruction – Learn from TÜV SÜD’s leading industry professionals and regulatory specialists.
- Engaging Learning Experience – Benefit from interactive sessions featuring lectures, case studies, and simulations.
- Professional Networking – Connect with peers and industry experts in a collaborative virtual environment.
- Competitive Advantage – Gain recognized credentials that demonstrate your regulatory proficiency.
- Receive globally recognized TÜV SÜD certificate upon completion
Instructor-led training in a virtual classroom. This means the course is Live Online. Participants will learn through online teaching. Lectures, case studies, group exercises, discussions, problem solving, examples with explanation, assignments and/or quizzes happen in the virtual classroom training. Participants need to connect to the class from any internet accessible location. Each module is delivered live using webinar technology, creating a virtual classroom learning environment. Live sessions provide you with direct access to the trainer so you can ask questions, understand complex concepts and share ideas with peers. Webcam and microphone are REQUIRED to interact with the instructor and/or other participants.
The course content and structure are designed by the domain experts from TÜV SÜD.
With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.
The training program culminates in an online proctored exam in which you will need your webcam on.
Requirements for Live Proctoring Examination:
- Students need to connect to the training session from an internet accessible location.
- Webcam and Microphone are REQUIRED.
- The examination venue must be a self-contained private room or office.
- When prompted by the online exam proctor, the complete work environment/room must be shown using the camera.
- There must be no other people in the room.
- No other materials are allowed in the vicinity of the PC/laptop other than permitted resources.
- No texts on the walls or desk.
- Quiet surroundings and no music, television or other sources of noise.
- No other computers or devices in the room are to be switched on.
- The room must be sufficiently lit (equivalent to daylight).
- Participants are not permitted to create or distribute transcripts of the examination contents (electronically and/or manually).
- Participant makes/receives a telephone call during the examination.
- Another person appears in the room.
- During the examination, the browser displaying the examination is left and answers are researched online despite this being prohibited by the examination regulations (closed book).
- Documents/notes are positioned on or around the laptop/monitor that enable the participant to cheat.
Participants will receive Certificates of Attendance from TÜV SÜD Academy for all five (5) individual training modules.
And upon passing the final exam, successful participants will receive their globally recognized TÜV SÜD certificate on "MDR-Expert".
Please bring a copy of the MDR with you to the course. A free copy can be downloaded from the EUR-Lex European Union law website.