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

  • A white background with a few lines on it

    Slide title

    "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

  • A white background with a few lines on it

    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

  • A white background with a few lines on it

    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.

Join The Wait List Request On-Site Details
A man in a suit and tie with a plus sign on his chest.

Course Director

A dollar sign in a circle on a white background.

Course Fee

$2650.00 Regular Registration

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

A black and white icon of a piece of paper with an exclamation point.

Course Brochure

New brochure coming soon!

A black and white icon of a calendar on a white background.

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 aims at improving/increasing patient safety, particularly in areas such as clinical testing requirements, clinical efficacy, product registration, centralized product database, traceability, labeling, and post market surveillance, etc. A grace period is planned for each of these regulations to help the industry transition into full compliance.

 

This 20 hour course 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 lifecycle management. Students will be led through 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 standard, Notified Body designations, conformity/certification standards, and paths to CE Mark and compliance, etc.       

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 designed to benefit the following disciplines and personnel:


  • Regulatory Affairs
  • QMS & Compliance Management
  • Product Managers
  • Sales & 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 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 lifecycle of a medical device
    • Understand the EU CE mark requirements & compliance pathway
    • Identify & search for applicable standards & guidance documents
    • Describe the Quality Management System and technical documentation requirements
    • Compare & contrast key provisions:  EU MDR vs. US MDR
    • Plan gap analysis and strategize for transitioning from EU MDD to the new EU MDR

  • Agenda


    Section 1. EU’s regulatory framework for Medical Devices

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

    Section 2. Quality Management Systems Fundamentals

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

    Section 3. EU MDR Fundamentals

    • What:
    1. Medical device definition & classification
    2. CE Marking & 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 & Classification

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

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

    Section 7. Best Practices Considerations

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

    Course Summary and Q&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

Registrant Information:

Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.