Overview of the New EU Medical Devices Regulations: MDR, IVDR, CE Mark and Compliance, QMS Fundamentals

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    "The course director was very knowledgeable and was able to engage the audience in a manner that was very informative and productive. What could have been very dry course material was presented in a way that made it interesting and relevant."


    Kim Pennington, RAQA Project Lead, Teleflex

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    Slide title

    "I enjoyed the real life examples and that the Course Director followed up on our questions throughout the course. Everything was  clearly communicated and was easy to understand, even though this topic is complicated.  The Course Director  was very knowledgeable and is great presenter!"


    Josephine H., Regulatory Professional, Novo Nordisk

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    Slide title

    "The Instructor was very knowledgeable on the content of the course. We were able to question and get answers to our queries.  The experience and real-life examples help us better understand the varied concepts of the course.  Many, many examples and products were discussed to explain. This course had tremendous two way communication. A really good course --- looking forward to the next course with the same instructor. Many useful handouts and sources were given to us."  


    Tasneem A., QS Auditor, NDC

Next Course

20-Hour Live Stream or On-Site

This course is being offered on an as-requested basis. Please join the wait list or request on-site delivery details.

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Course Director

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Course Fee

$2650.00 Regular Registration

$2450.00 Early Bird Pricing (Register 30 Days in Advance)

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Future Live Stream Sessions (click to register)

Course Description

The EU Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746) came into force in 2017 to replace existing medical device directives. The main objective of these new regulations is to improve patient safety, particularly in areas such as clinical testing requirements, clinical efficacy, product registration, centralized product database, traceability, labeling and post-market surveillance. 


This 20-hour European Union medical device regulations CE marking course, led by Wen Schroeder, provides an overview of the legislative development leading to today’s EU MDR 2017/745, the contributing socioeconomic and environmental factors, as well as the regulatory framework and enforcement priority shift from pre-market approval to post-market surveillance and life cycle management. 


Students will be led through an in-depth discussion on the many changes brought about by the new EU MDR: roles and responsibilities of various industrial players, product definitions, classification criteria, identification standards, notified body designations, conformity/certification standards and paths to CE Mark and compliance. 



This in vitro diagnostic regulations European course will also examine the International Organization for Standardization (ISO) standards for medical devices, risk management expectations and documentation control requirements that support CE marking and life cycle compliance.

Who Should Attend

This course will be of immense value to medical device professionals involved in marketing and supporting medical devices in the European Community. It is particularly relevant for professionals responsible for ensuring CE marking requirements for medical device manufacturers are met and maintained throughout the product life cycle. Those seeking training on medical device compliance with European Union regulations to support regulatory submissions or internal quality management systems implementation will benefit from this program.


It is designed to benefit the following disciplines and personnel:



  • Regulatory Affairs
  • QMS and Compliance Management
  • Product Managers
  • Sales and Marketing
  • Product Development
  • Quality Assurance
  • Manufacturing
  • Research and Development
  • Risk Management
  • Clinical Affairs 


Join The Wait List Request On-Site Details

  • Learning Objectives

    By the end of this EU and Quality management systems ISO standards medical devices training course, participants will be able to:


    • Describe the regulatory scope and objectives of the new EU MDR
    • Understand the historical evolutionary path leading to the new EU MDR
    • Compare and contrast the MDD vs. MDR
    • Describe the regulatory requirements throughout the life cycle of a medical device
    • Understand the EU CE mark requirements and compliance pathway
    • Identify and search for applicable standards and guidance documents
    • Describe the Quality Management System and technical documentation requirements
    • Compare and contrast key provisions: EU MDR vs. U.S. MDR
    • Plan gap analysis and strategize for transitioning from EU MDD to the new EU MDR
    • Explain conformity assessment standards and the roles of economic operators within the EU 
    • Apply ISO quality management systems principles
    • Identify technical documentation, UDI, EUDAMED and post-market surveillance reporting obligations

  • Agenda


    Section 1. EU’s regulatory framework for Medical Devices

    • EU and the legislative framework
    • What are medical devices?
    • Relevant EU directives
    1. AIMD, MDD, IVDMDD…
    • Introduction to EU MDR and IVDR: 
    1. Scope
    2. Legal basis
    3. Legislative philosophy and regulatory oversight
    4. Quality management systems
    5. Regulatory guidance
    • US MDR vs. EU MDR/IVDR
    1. Key provisions
    2. Comparison and contrast
    3. Future trends

    Section 2. Quality Management Systems Fundamentals

    • Introduction
    • ISO 13485 and EN ISO 13485:2016 brief
    • Other relevant ISO and international regulatory standards
    • Future trends

    Section 3. EU MDR Fundamentals

    • What:
    1. Medical device definition and classification
    2. CE Marking and conformity
    • Who:
    1. The competent authority
    2. The notified body
    3. The economic operator:  manufacturer, importer, distributor, authorized representative
    • When:
    1. Implementation timeline

    Section 4. EU MDR Specifics I:  Safety, Performance and Classification

    • General Outline
    • Safety and performance requirements
    1. MDD vs. MDR
    • Device Classification Basics 
    • Recap and Q&A

    Section 5. EU MDR Specifics II.  Technical Documentation Essentials

    • Technical documentation requirements
    • UDI
    • Traceability
    • EUDAMED
    • Legacy Devices
    • IT Tools

    Section 6. Path to CE Marking and Conformity 

    • Process Outline
    1. Roles and responsibility of players
    2. Classification review and decision making
    3. Product-specific requirements
    4. Route to conformity
    5. Device testing
    6. Technical documentation
    7. Declaration of conformity
    • Clinical investigation and compliance
    • Risk assessment and management

    Section 7. Best Practices Considerations

    • CE Marking Roadmap
    • QMS Maintenance
    • Transition Strategy and Recommendation
    • PMS Reporting and Responsibilities
    • Lifecycle Management

    Course Summary and Q and A

  • Testimonials

    "I enjoyed the real life examples and that the Course Director followed up on our questions throughout the course. He clearly communicated and was easy to understand, even though this topic is complicated. He was very knowledgeable and is great presenter!"

    Josephine H., Regulatory Professional, Novo Nordisk


    "The course was very interactive and informative. The course director went the extra mile to explain difficult issues for us to understand."

    Genevieve B., Regulatory Officer, Food and Drugs Authority - Ghana


    "The course director was very knowledgeable and was able to engage the audience in a manner that was very informative and productive. What could have been very dry course material was presented in a way that made it interesting and relevant."

    Kim Pennington, RAQA Project Lead, Teleflex


    "This Course Director is one of the best teachers I, as an Academic Dean, have had the pleasure to learn from."

    William G., CSO & Board Chair, Nova Scan


    "The Instructor was very knowledgeable on the content of the course. We were able to question and get answers to our queries. His experience and real-life examples help us better understand the varied concepts of the course. Many, many examples and products were discussed to explain. This course had tremendous two way communication. A really good course --- looking forward to the next course with the same instructor. Many useful handouts and sources were given to us."

    Tasneem A., QS Auditor, NDC


    "I enjoyed the course. It was very informative with not only the basic required information, but practical and real examples and experiences. Mr. Lee would answer questions with product explanations aimed at our business."

    Garth A., Quality Engineering Lead, Parker Hannifin

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