Implementing the EU’s New Medical Device Regulation (MDR 2017/745)

Course Objectives

At the end of this workshop, participants will be able to:

• Describe the objectives and structure of the MDR.
• Identify the key differences between the requirements found in the existing directives and the MDR.
• Explain the impact of the new MDR requirements on economic operators, including manufacturers.
• Describe the different regulatory requirements through life-cycle of device, e.g. premarket, design and development, product realization, and postmarket.
• Identify the necessary steps to prepare an organization to transition to the MDR.
• Plan a gap assessment to transition an organization to compliance.

Course Topics

• The objectives of the MDR, including the significance of replacing directives with a regulation
• Quality management system requirements in the MDR
• Device classification and conformity assessment route changes in the MDR
• Technical documentation requirements in the MDR
• Clinical evaluation process requirements in the MDR
• UDI and traceability requirements in the MDR
• Postmarket surveillance and reporting requirements in the MDR
• Life-cycle review of products linked to risk management and clinical evidence
• Auditing impact of the MDR

Highlighted Handouts and Resources

• Matrix of Annex I Requirements (MDD Essential Requirements Compared to MDR General Safety and Performance Requirements)
• MDR Transition Quality Plan Tool
• A Pathfinder for the Medical Device Regulation and its Annexes. These serve as tables of contents for the 175+ page regulation
• EU Glossary with definitions of key terms

Who Should Attend

Medical device professionals in areas of quality and regulatory affairs, design, risk management, postmarket activities, R&D, and manufacturing, who work for manufacturers that market devices in the EU. 

Virtual Class Days

• This training is delivered as five consecutive half-day sessions.
• Daily sessions run from 1:00-5:00 p.m. Eastern Standard Time.

Related Courses

• EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745)
• US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training
• Implementing the EU's New In Vitro Diagnostic Regulation Training (IVDR 2017/746)
• CER (Clinical Evaluation Report) Training for EU MDR Compliance

Virtual Session Details

Oriel STAT A MATRIX Virtual Instructor-Led Training (VILT) is a real-time internet-based learning experience where the instructor and learners are in separate locations. Oriel STAT A MATRIX’s VILT technology platform is designed to simulate a traditional in-person classroom experience and allows for 2-way dialogue, break-out sessions for engaged workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which participants can connect with the content and interact with both the instructor and other classmates.

Online Training Schedule

• This training is delivered as five consecutive half-day sessions.
• Daily sessions run from 1:00-5:00 p.m. Eastern Standard Time.
• This convenient half-day format allows you to balance your other responsibilities while still getting the training you need. 

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

See course dates to find / register for a virtual online session of this course.