Medical Device Regulation (MDR) in Detail
EU MDR with USA/Canada Alignment
 | Top-selling course |
EU MDR with USA/Canada Alignment
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.
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).