Exam MDR-Expert - TÜV
Have your knowledge tested and confirmed as an MDR Expert – TÜV
Our modular training to become an "MDR Expert – TÜV" offers you a comprehensive training program for the implementation of EU Regulation 2017/745 MDR. In the various modules, you will learn about the regulatory requirements of the MDR and understand the changes that your company will have to cope with in a timely manner. With the successful examination as an "MDR Expert – TÜV", you prove your qualification for the latest medical technology regulations and enable your company to successfully and safely bring medical devices to market even after the MDR comes into force.
By completing the exam, candidates demonstrate mastery of MDR requirements, including:
- Structure, terminology, and classification rules under EU MDR 2017/745
- Implementation of MDR requirements into QMS processes
- Post-Market Surveillance (PMS) and Post-Market Clinical Follow‑up (PMCF) requirements
- EUDAMED data submission and regulatory expectations
- Responsibilities of the Person Responsible for Regulatory Compliance (PRRC)
Passing the exam confirms the participant’s qualification as an MDR Expert – TÜV and verifies their ability to support compliant market access for medical devices.
- Managers Regulatory Affairs, Quality Management Office
- Heads of Research & Development
- Safety officers and managing directors in medical technology companies
- Importers
- Distributors and medical device consultants
- EU Authorised Representatives and Surveillance Staff
- Consultants and other service providers
- 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
- EUDAMED (European Database on Medical Devices)
- Knowing and implementing requirements
- Person Responsible for Regulatory Compliance (PRRC)
- Requirements and scope of the PRRC
The MDR‑Expert – TÜV online exam is the final assessment required to complete the MDR Expert qualification program. This examination validates the participant’s understanding of the EU Medical Device Regulation (EU MDR 2017/745) and confirms their competency in applying MDR principles in regulatory, quality, and compliance roles.
Successful candidates receive a globally recognized TÜV SÜD certificate demonstrating proficiency in navigating the latest regulatory requirements for medical devices.
Benefits of the MDR‑Expert – TÜV Certification
1. Official, Globally Recognized Verification of MDR Expertise
Passing the exam grants the participant a globally recognized TÜV SÜD MDR‑Expert certificate, confirming their mastery of EU MDR 2017/745 regulatory requirements.
This certification signals to employers, notified bodies, and regulatory authorities that the holder has a validated, third‑party–confirmed understanding of MDR compliance.
2. Demonstrates Ability to Implement MDR Requirements in Practice
The exam validates the candidate’s ability to apply MDR concepts in real environments, including:
- Device classification
- Quality management system (QMS) alignment
- PMS and PMCF implementation
- EUDAMED data obligations
- PRRC (Person Responsible for Regulatory Compliance) responsibilities
This strengthens professional credibility in operational and regulatory roles.
3. Supports Organizational MDR Compliance & Market Access
Certified MDR Experts help their organizations:
- Align processes with MDR expectations
- Reduce compliance risks
- Prepare for audits and notified body assessments
- Bring medical devices to market safely and legally under MDR
This supports uninterrupted EU market access and reduces regulatory delays.
4. Enhances Professional Qualification and Career Advancement
The certification formally documents advanced regulatory knowledge, making it valuable for roles in:
- Regulatory Affairs
- Quality Management
- R&D leadership
- Clinical/medical device strategy
- Importing, distributing, or consulting
This can support promotions, new responsibilities, or cross‑functional advancement.
5. Provides Competitive Advantage in the Medical Device Industry
With MDR representing one of the most significant regulatory shifts in decades, professionals who hold verified MDR expertise stand out in the talent market.
Their certification signals readiness to navigate complex regulations that many organizations still struggle to interpret.
6. Confirms Completion of a Comprehensive MDR Training Pathway
The exam caps a five‑module structured training program, ensuring that certified individuals have completed rigorous, in‑depth learning before being assessed.
This provides employers with assurance of consistent, high‑quality regulatory education.
7. Ensures Up‑to‑Date Understanding of Evolving MDR Expectations
The certification reflects current MDR requirements, including PMS, PMCF, and EUDAMED expectations—areas of active regulatory enforcement.
Professionals gain confidence staying compliant in a dynamic regulatory landscape.
8. Increases Trust From Notified Bodies and Regulatory Stakeholders
A TÜV‑verified credential shows a commitment to regulatory excellence and adherence to high compliance standards, building trust with auditors, partners, and clients.
Exam Format
- Duration: 1 hour
- Delivery: Online, proctored in real time
- Candidates may communicate with the online proctor via chat.
- Participants must follow all instructions provided by the examination supervisor.
- A suitable private testing environment is required (see exam requirements below).
Online Examination Requirements
Participants must ensure:
- A self-contained private room or office free from interruptions
- The entire room and workspace can be shown via webcam upon request
- No materials present except those explicitly allowed
- No other electronic devices powered on nearby
- A quiet environment free of background noise
- Adequate lighting equivalent to daylight
- Full compliance with all online proctoring instructions
Violations (e.g., phone calls during the exam, failure to follow requirements, presence of unauthorized materials) may lead to disqualification or a finding of attempted cheating. Participants are prohibited from creating or distributing any exam content.
Upon successful completion, candidates receive the official TÜV SÜD MDR‑Expert Certificate, recognized globally by industry stakeholders and regulatory bodies.
To complete the MDR Expert - TÜV course, you must attend the five (5) individual training modules as well as successfully complete the MDR Expert - TÜV exam.