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 former directives and the MDR.
• Explain the impact of the MDR requirements on economic operators, including manufacturers.
• Describe the different regulatory requirements through the life-cycle of a device (e.g., premarket, design and development, product realization, and postmarket).
• Identify the necessary steps to prepare an organization to follow the MDR.
• Plan a gap assessment to guide 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 Implementation Quality Plan Tool
• A Pathfinder for the Medical Device Regulation and its Annexes, which serves as a table 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.