Medical Device Regulation (MDR) in Detail
EU MDR with USA/Canada Alignment
 | Top-selling course |
This course provides a practical and comprehensive overview of the European Union Medical Device Regulation (EU MDR 2017/745), covering key regulatory requirements such as device classification, General Safety and Performance Requirements (GSPR), technical documentation, clinical evaluation, post-market surveillance (PMS), vigilance, Unique Device Identification (UDI), EUDAMED, and the responsibilities of economic operators. Participants also gain insight into the latest MDR amendments, including updated transitional provisions and EUDAMED implementation timelines.
In addition to EU MDR requirements, the training explores regulatory alignment with North American markets by introducing the FDA’s Quality Management System Regulation (QMSR) and Health Canada’s CMDR and MDSAP requirements. Through expert-led instruction, case studies, and interactive discussions, attendees will learn how to develop audit-ready regulatory processes, compare global post-market reporting obligations, and strengthen compliance strategies for marketing medical devices across the EU, United States, and Canada.
In this training course, you will:
- Receive a compact and practice‑focused overview of the European Medical Device Regulation (EU) 2017/745 (MDR), including classification, conformity assessment, technical documentation, clinical evaluation, PMS, vigilance, UDI, and EUDAMED requirements.
- Understand organizational responsibilities under MDR for manufacturers, Authorized Representatives, importers, and distributors.
- Learn how MDR obligations interact with North American regulatory systems, including:
- FDA’s new Quality Management System Regulation (QMSR) (replacing the legacy 21 CFR 820 Quality System Regulation).
- Health Canada CMDR requirements and MDSAP, including MDL/MDEL licensing, bilingual labeling, and incident reporting obligations.
- Compare post‑market reporting requirements across EU, USA (21 CFR 803), and Canada (CMDR 59–61) to understand global surveillance expectations.
Testimonials:
- "A great introduction to MDR and an excellent refresher for teams working toward MDR certification. The comparisons between EU MDR, FDA, and Canada requirements were especially valuable."
- "The instructor kept the training engaging and practical throughout the day. The slide materials and real-world regulatory insights made complex MDR topics much easier to understand."
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 marketing medical devices to the EU and/or North American markets, including:
- Regulatory Affairs
- Quality & Risk Management
- Clinical Affairs
- R&D and Design Engineering
- Manufacturing, Quality Assurance, and Supply Chain
- PRRCs and individuals preparing for PRRC responsibilities
- Importers, distributors, and economic operators supporting EU/US/Canada compliance
- Consultants and new industry professionals seeking structured MDR + NA alignment knowledge
- Fundamentals of the Medical Device Regulation (MDR)
- Classification and Reclassification (Annex VIII; including software Rule 11)
- Non‑medical products within scope (Annex XVI)
- Common Specifications
- General Safety and Performance Requirements (GSPR)
- Technical Documentation (Annex II & III)
- Clinical Evaluation, PMCF & Evidence Requirements
- Post‑Market Surveillance (PMS), Vigilance & PSUR
- Scrutiny Procedure
- Transitional Provisions & Certificate Validity (including 2023/607 & 2024/1860 updates)
- Roles & Responsibilities of MDR Economic Operators
- Manufacturer
- Authorized Representative
- Importer
- Distributor
- Person Responsible for Regulatory Compliance (PRRC)
- EUDAMED (modules, mandatory‑use timelines, UDI/Device registration)
- UDI (EU vs USA GUDID comparison)
- NEW: Overview of FDA QMSR (21 CFR 820 modernization aligned with ISO 13485)
- NEW: Overview of Health Canada CMDR & MDSAP requirements
- NEW: Cross‑market vigilance comparison — EU MDR vs FDA 803 vs Canada CMDR
The European Union’s Medical Device Regulation (MDR 2017/745) introduced far‑reaching changes affecting all medical device manufacturers placing products on the EU market. This course provides a concise and practical deep‑dive into MDR requirements, including classification (Annex VIII), GSPR, technical documentation (Annex II/III), clinical evaluation/PMCF, PMS, vigilance, UDI, scrutiny, EUDAMED, and the responsibilities of all economic operators (manufacturer, Authorized Representative, importer, distributor, PRRC).
The course also explains the latest MDR amendments, including the extended transitional provisions (Regulations 2023/607 and 2024/1860), and the phased mandatory‑use rollout of EUDAMED modules.
To support organizations operating internationally, the training includes an orientation to FDA’s new Quality Management System Regulation (QMSR)—effective February 2, 2026—which replaces the legacy Quality System Regulation and aligns 21 CFR 820 with ISO 13485. It also covers Health Canada’s CMDR requirements, including MDSAP expectations, MDL/MDEL licensing, bilingual labeling, and incident‑reporting timelines.
By the end of the training, participants will understand the MDR life‑cycle approach, how MDR interfaces with North American regulatory systems, and how to prepare robust, audit‑ready processes and documentation.
- Attending the seminar will help you prove your professional qualifications as part of your company's MDR certification.
- Comparison of EU MDR, FDA QMSR, and Health Canada CMDR for organizations operating across multiple markets.
- World-class training – by learning from TÜV SÜD’s industry experts and training specialists.
- Interactive learning style – with interactive formats such as lectures, illustrations and simulations are used.
- Networking opportunity – where you can meet and build network with like-minded individuals at our instructor-led training.
- Gain a competitive edge – by getting trained by experts known in the fields of safety, security, and medical devices.
- This seminar is offered as a basic module of the modular continuing education courses. After successful participation in the advanced modules, you can acquire the recognized MDR-Expert - TÜV degree.
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.
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.
Participants will receive a Certificate of Attendance from TÜV SÜD Academy.
Supplementary reference tables comparing EU MDR vs FDA QMSR vs Health Canada CMDR are provided as part of the course materials.
As a participant, you will receive a digital copy of the paperback Medical Device Regulation (MDR).
1. What is this course about?
This course provides a practical, in-depth overview of the European Medical Device Regulation (EU MDR 2017/745), including classification, conformity assessment, technical documentation, clinical evaluation, post-market surveillance (PMS), vigilance, UDI, EUDAMED, and the responsibilities of economic operators. It also includes an introduction to FDA Quality Management System Regulation (QMSR) and Health Canada CMDR/MDSAP requirements for organizations operating globally.
2. Is this course suitable for beginners?
Yes. The course is designed as a foundational MDR training and is suitable for professionals who need a structured understanding of MDR requirements, whether they are new to medical device regulations or looking to strengthen their existing knowledge.
3. Does the course cover the latest MDR updates?
Yes. The training includes the latest MDR amendments, extended transition periods, EUDAMED developments, UDI requirements, and recent regulatory updates impacting manufacturers and economic operators.
4. Will the course explain MDR device classification?
Yes. Participants will learn how MDR classification rules work, including key changes from previous directives, software classification under Rule 11, implantable device classifications, and reclassification impacts on conformity assessment requirements.
5. Does the training include software and digital health devices?
Yes. The course addresses MDR Rule 11 for Medical Device Software (MDSW), including software used for diagnostic and therapeutic decision-making, cloud-based applications, and mobile health technologies.
6. Will I learn about UDI and EUDAMED?
Absolutely. The course explains EU UDI requirements, EUDAMED modules, registration obligations, implementation timelines, and how EU requirements compare with U.S. UDI requirements.
7. Does the training cover technical documentation requirements?
Yes. Participants will gain an understanding of Annex II and Annex III requirements, including device descriptions, risk management documentation, labeling, clinical evidence, PMS documentation, and audit-ready technical files.
8. Is clinical evaluation covered in the course?
Yes. The training explains clinical evaluation requirements, clinical investigations, equivalence considerations, clinical evidence expectations, PMCF planning, and Summary of Safety and Clinical Performance (SSCP) requirements.
9. Will the course explain post-market surveillance and vigilance?
Yes. Participants will learn how to establish and maintain PMS systems, conduct vigilance activities, prepare PSURs, perform trend reporting, and understand reporting requirements across the EU, U.S., and Canada.
10. What will I learn about the Person Responsible for Regulatory Compliance (PRRC)?
The course explains PRRC qualification requirements, responsibilities, documentation oversight, PMS obligations, reporting duties, and how organizations can meet MDR compliance expectations for this role.
11. Does the course compare EU MDR with FDA and Health Canada requirements?
Yes. A dedicated section introduces FDA’s QMSR and Health Canada CMDR/MDSAP requirements, helping participants understand similarities, differences, and compliance expectations across multiple regulatory markets.
12. What will I learn about FDA QMSR?
Participants will learn how the FDA's Quality Management System Regulation aligns with ISO 13485, key implementation changes, Medical Device File (MDF) requirements, and retained FDA-specific requirements such as UDI, MDR reporting, device tracking, and corrections/removals.
13. Does the course include Health Canada requirements?
Yes. The training provides an overview of CMDR requirements, MDSAP expectations, MDL/MDEL licensing, bilingual labeling obligations, PMS activities, recalls, and incident reporting requirements.
14. How is the course delivered?
The course is delivered as instructor-led live online training in a virtual classroom environment. Participants engage through presentations, practical examples, discussions, case studies, exercises, and interactive learning activities.
15. Is the training interactive?
Yes. The course incorporates polls, discussions, practical examples, group exercises, and Q&A sessions to help participants apply MDR concepts to real-world situations.
16. Will I receive a certificate?
Yes. Participants receive a TÜV SÜD Academy Certificate of Attendance upon successful completion of the training.