Sustaining an MDR (Medical Device Regulation) compliant QMS through continuous audit readiness
Maintain MDR Compliance with Confidence Through Continuous Audit Readiness and Effective QMS Management
The EU Medical Device Regulation (MDR 2017/745) has fundamentally changed regulatory, quality management, clinical, post-market, and audit expectations for medical device manufacturers. Organizations must continually demonstrate compliance, maintain audit readiness, and effectively manage evolving regulatory obligations throughout the product lifecycle.
This course provides a practical understanding of MDR audit requirements and the key quality system processes that are routinely assessed by Notified Bodies. Participants will learn how MDR impacts quality management systems, technical documentation, risk management, clinical evaluation, post-market surveillance, vigilance, economic operators, UDI implementation, and other critical compliance activities needed to sustain long-term MDR conformity and successful audit outcomes.
Successful participants in this training will:
- Acquire audit requirements according to MDR in a compact way.
- Gain knowledge of new elements in the audit context based on the MDR.
- Get a profound overview of the changes that arise in the audit due to the MDR.
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 intended for:
- Internal Auditors
- Lead Auditors
- Regulatory Affairs Professionals
- Quality Assurance Professionals
- Quality Managers
- Quality Management Representatives
- Clinical Affairs Professionals
- Product Development Professionals
- Product Managers
- Project Managers
- Compliance Managers
- Person Responsible for Regulatory Compliance (PRRC)
- Medical Device Manufacturers
- Authorized Representatives
- Importers and Distributors with MDR compliance responsibilities
- Professionals involved in MDR implementation, maintenance, and audits
Day 1
Introduction
- MDR implementation landscape
- Audit readiness fundamentals
- MDR audit expectations
MDR Regulatory Framework
- MDR legal basis
- Key changes introduced by MDR
- Conformity assessment routes
Audit Processes Under MDR
- Audit lifecycle
- Annex VII requirements
- Audit planning and execution
General Safety and Performance Requirements (GSPR)
- Annex I overview
- Audit implications
- Compliance expectations
Technical Documentation
- Technical documentation structure
- Audit review expectations
- Classification considerations
Labeling Requirements
- MDR labeling changes
- IFU requirements
- Promotional material considerations
MDR Impact on QMS
- Article 10 manufacturer obligations
- MDR-specific quality system expectations
- Relationship with ISO 13485
Day 2
Risk Management
- MDR and ISO 14971
- Risk analysis methods
- Risk-management audit expectations
Clinical Evaluation & Clinical Investigation
- Clinical evidence requirements
- MDR clinical evaluation expectations
- Clinical investigation requirements
Vigilance and Trend Reporting
- Incident reporting requirements
- Trend reporting
- Field Safety Corrective Actions (FSCA)
Post-Market Surveillance (PMS)
- PMS planning
- PMS reports and PSUR
- Lifecycle monitoring
Post-Market Clinical Follow-Up (PMCF)
- PMCF planning
- PMCF methods
- PMCF deliverables
UDI and EUDAMED
- UDI requirements
- Registration obligations
- Traceability expectations
PRRC and Economic Operators
- PRRC responsibilities
- Importer and distributor obligations
- Authorized representative requirements
Remote Audits
- Remote auditing considerations
- Audit preparation strategies
- Documentation and technology requirements
The European Medical Device Regulation (EU MDR 2017/745) significantly expanded the expectations placed upon medical device manufacturers, authorized representatives, importers, distributors, and quality management personnel. Achieving MDR compliance is only the first step. Organizations must continuously maintain compliance and remain prepared for audits conducted by Notified Bodies, competent authorities, and internal audit teams.
This comprehensive course provides participants with a practical understanding of how MDR requirements affect audit preparation, audit execution, and ongoing quality management system maintenance. Participants will explore the regulatory framework of MDR, key audit expectations, conformity assessment pathways, and the requirements applicable to manufacturers and other economic operators throughout the medical device lifecycle.
The training examines the most critical MDR compliance areas reviewed during audits, including General Safety and Performance Requirements (GSPR), technical documentation, design and development controls, risk management, clinical evaluation, clinical investigations, labeling, promotional material requirements, and Unique Device Identification (UDI). Particular attention is given to Article 10 manufacturer obligations and MDR-specific quality management system requirements that extend beyond ISO 13485.
Participants will also learn how MDR requirements influence post-market activities including vigilance, trend reporting, post-market surveillance (PMS), post-market clinical follow-up (PMCF), field safety corrective actions, and EUDAMED registration obligations. The course explains how these interconnected processes contribute to maintaining continuous compliance and supporting successful audit outcomes.
By the end of the course, attendees will gain a structured framework for evaluating their organization's readiness for MDR audits, identifying compliance gaps, strengthening internal audit activities, and sustaining an MDR-compliant quality management system through continuous audit readiness practices.
After completing this course, you will be able to:
- Explain the structure and regulatory framework of MDR 2017/745.
- Describe the MDR audit process and key audit criteria.
- Interpret the impact of MDR requirements on quality management systems.
- Evaluate compliance with General Safety and Performance Requirements (GSPR).
- Understand conformity assessment routes and Notified Body expectations.
- Assess technical documentation readiness for audits.
- Identify MDR requirements related to clinical evaluation and clinical investigations.
- Apply MDR risk management expectations using ISO 14971 principles.
- Understand vigilance, PMS, PMCF, and trend reporting obligations.
- Explain labeling, UDI, PRRC, and EUDAMED requirements.
- Understand the responsibilities of manufacturers, authorized representatives, importers, and distributors.
- Prepare organizations for successful onsite and remote MDR audits.
Upon completion of this training, you will be able to:
- Understand MDR audit expectations and Notified Body assessment approaches.
- Strengthen organizational audit readiness and compliance monitoring activities.
- Identify MDR-specific QMS requirements beyond ISO 13485.
- Better understand Article 10 manufacturer obligations.
- Improve preparation of technical documentation and audit evidence.
- Assess compliance with GSPR requirements and applicable standards.
- Understand MDR requirements for Clinical Evaluation and PMCF.
- Improve vigilance, PMS, and trend reporting processes.
- Understand UDI, EUDAMED, and economic operator obligations.
- Prepare for both onsite and remote MDR audits.
- Reduce audit findings through proactive compliance management.
- Build a sustainable framework for continuous MDR compliance.
This instructor-led virtual training combines:
- Expert lectures
- Practical examples
- Case studies
- Interactive discussions
- Group exercises
- Knowledge checks
- Real-world audit readiness scenarios
- Q&A sessions with the instructor
Participants learn in a live virtual classroom environment with direct interaction and feedback from the trainer.
Participants' understanding will be assessed through:
- Knowledge checks throughout the course
- Interactive discussions
- Practical compliance examples
- Group exercises
- Case-study based activities
- Instructor-led question-and-answer sessions
Participants who successfully attend and complete at least 90% of the training will receive a TÜV SÜD Academy Certificate of Attendance.
Participants will receive:
- Digital course workbook
- Presentation materials
- Practical examples and case studies
- Exercises and knowledge-check activities
- Reference resources supporting MDR audit readiness concepts
Participants should have a basic understanding of:
- Medical Device Regulation (EU MDR 2017/745)
- Quality Management Systems
- ISO 13485
- Medical device regulatory processes
Previous auditing experience is desirable but not mandatory.
Does this course teach the full MDR regulation?
The course focuses on MDR requirements most relevant to audit readiness, QMS compliance, and successful interactions with Notified Bodies.
Is this course suitable for internal auditors?
Yes. The course is highly relevant for internal auditors who need to evaluate MDR compliance and prepare organizations for external audits.
Does the course cover ISO 13485?
The training discusses ISO 13485 in relation to MDR requirements and highlights where MDR introduces additional expectations.
Will Clinical Evaluation and PMCF be covered?
Yes. The course explains Clinical Evaluation, PMCF requirements, and how these activities are assessed during audits.
Does the training cover risk management?
Yes. Participants will learn the MDR expectations for risk management and the relationship with ISO 14971.
Will UDI and EUDAMED requirements be discussed?
Yes. The course includes MDR requirements for UDI implementation, device registration, and EUDAMED obligations.
Does the course explain the responsibilities of importers and distributors?
Yes. Economic operator obligations, including manufacturers, authorized representatives, importers, and distributors, are covered.
Are remote audits included?
Yes. The course discusses audit preparation and considerations for remote audits under MDR.
Is prior MDR experience required?
A basic understanding of MDR and quality management concepts is recommended, but extensive experience is not required.
What type of certificate is issued?
Participants receive a TÜV SÜD Certificate of Attendance upon successful completion of the course.
How is this course different from a general MDR overview course?
This training specifically focuses on sustaining an MDR-compliant QMS and maintaining continuous audit readiness rather than providing only an introductory MDR overview.
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