Industries: Medical Device

Medical Devices: The New MDRs, EU Directives, Guidance, CE Marking and ISO Standard Certifications

Course Director: Jonathan Lee

Course Fee: $2150.00 Regular Registration / $1950.00 Early Bird (30 Days in Advance)

  Accreditation: ***RAPS Approved Course*** 

PharmaTrain Recognized Course    


Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

The NEW Medical Device Regulations (MDRs) are here and things are in transition for Medical Devices and IVDs in the European Union (EU). Coupled with this are updated Quality Management Systems standard requirements (ISO 13485:2016) and, there is also BREXIT.

Now what is now needed to enter or, more importantly, to maintain presence in the EU marketplace for medical devices?  Satisfying requirements harmonized across the 28-member states should be a straightforward process - but is it?

This course identifies and explains the requirements – old, new and transitional – for medical devices, the steps to obtain entry into the marketplace (including setting up on-going procedures and relationships), the increasing importance of Clinical Evaluation and Post Market surveillance, Notified Bodies and Competent Authorities.  The course also shares lessons learned from the Course Director, who has over 25 years of experience with CE marking medical devices for distribution in the EU and is actively consulting on managing the transition to 2020.

Also covered is the meaning of the CE symbol and how & when to legitimately apply this mandatory mark of conformity, the roles of Notified Bodies, Competent Authorities, and Authorized Representatives.  Additionally, the significance of the QMS, the updated ISO 13485 and ISO 14971 standards, and reference to ISO 14000.  The importance of these standards as necessary elements in addressing the Essential Requirements (and the General Safety & Performance Requirements), technical files, declarations of conformity and the six steps required for manufacturers to market Medical Devices in the European market.

Throughout the course, examples and case studies will help participants apply the concepts being covered and with the extensive resource material provided, prepare attendees for the transition to the new standards and the new EU Regulations.

With the three-year transition clock for QMS compliance running until 2019, and the three-year transition period for conforming to the new regulations ending in 2020, time is running out. Regulatory and Compliance professionals are strongly encouraged to attend.

Who Should Attend

This course will be of great value to medical device professionals involved in marketing and supporting medical devices in the European Community. It is primarily 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

Course Agenda

Day One

Introduction to the European Commission, the EU, and the CE Mark for Medical Devices:

  • Differences in approach & philosophy
  • MedDev


  • The Directives, The MDR Regulations
  • Key differences
  • UDI
  • Device types
  • The Rules & Device classifications
  • Declaration of Conformity

European Commission's 6 Steps for Manufacturers

Introduction to the "Players:"

  • The Medical Device Manufacturer
  • The Competent Authority
  • The Notified Body
  • The Authorized Representative

Quality Management System (QMS & EMS):

  • What are they?
  • The role of ISO 13485 & EN ISO 13485:2016
  • The Notified Body
  • The role – or not – of ISO 14001
  • Comparisons with:
    • FDA 820
    • rPAL
    • CMDCAS
    • TGA

"Green" Europe, standards and requirements to be aware of:

  • WEEE
  • RoHS
  • ISO 14000

Product Classification:

  • Sterilized product and the impact of TSEs
  • Devices with a measuring function
  • The MDD flow charts & MDR Differences

Overview of Important Documentation:

  • The Essential Requirements
  • The General Safety & Performance Requirements
  • The Technical Dossier/Design Dossier
  • Declarations of Conformity

Day 1 Review and Q&A

Day Two

Conformity Assessment, Certification & Obtaining the CE Mark:
  • The Six Steps (or is it 5?) to CE Marking

Key roles & Their Selection:

  • The Manufacturer
  • Competent Authorities
  • The Notified Body
  • The Authorized Representative
  • Person Responsible for Regulatory Compliance

Product Classification & Conformity Requirements:

  • Review of device types
  • Declarations of conformity

The General Safety & Performance Requirements:

  • What to include
  • Workbook Exercises
  • Do's & don'ts
  • Updating & transition

The Technical Dossier/Design Dossier:

  • Technical File/Design Dossier
  • Clinical Evaluation
  • Updated requirements for content
  • Risk Assessment
  • Not all reviews are the same

Marketing in Europe & Retaining the CE Mark:

  • Site QMS auditing
  • Managing & reporting change (Workbook Exercises)
  • Post Market Surveillance & its increasing importance
  • Field actions & the Vigilance System

Lessons Learned & Related Topics:

  • Labeling and language
  • MDR and the UDI requirements
  • Harmonized standards
  • The role of GHTF
  • "One World" and communication
  • Involvement of the CAs
  • Politics and specialties
  • Europe and GREEN policies
  • Key websites

Course summary and Q&A

Learning Objectives

By the end of this course, participants will:

  • Understand the EU requirements for applying the CE mark to medical devices
  • Understand the applicable standards & guidance documents
  • Know the difference between a Competent Authority and a Notified Body
  • Understand the importance of the partnership with a Notified Body
  • Understand the impact of EU directive compliance on the Quality Management System
  • Know the similarities & differences between FDA requirements & European directives
  • Know the steps to follow to obtain the CE mark
  • Know the technical & support documentation needed
  • Understand the role of the Authorized Representative


""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." JGenevieve 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
RAPS | Regulatory Affairs Professionals Society CfPIE is a Regulatory Affairs Professional Society (RAPS) RA Professional Development provider.

CfPIE is committed to enhancing the ongoing professional development of regulatory affairs professionals and others through appropriate regulatory affairs learning activities and programs.  CfPIE has agreed to follow RAPS-established operational and educational criteria.  Click here for the list of courses reviewed and approved by RAPS.


Attendees Speak Out

Hear from attendees on the CfPIE's 2-day "Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications" course and learn, in their own words, how they expanded their knowledge on in marketing and supporting medical devices in the European Community.

Meet the Instructor

Meet Jonathan Lee, CfPIE's Course Director for “Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications Course”. Jonathan gives a snapshot of the 2-day classroom course which introduces the Medical Device Directives (AIMD, MDD & IVDMDD), the meaning of the CE symbol and how & when to legitimately apply this mandatory mark of conformity.