Dates and Venues

Gain an essential understanding of medical device regulation (MDR) requirements in the EU on this MDR training course.

This 1-day course offers an introduction to the new regulation (EU) 2017/745 and CE marking. Compliance with this set of regulations is mandatory for any medical device manufacturers who wish to sell their products into the EU marketplace.

By the end of the course delegates will understand how the regulation applies in their organisation and how to begin implementing systems to meet those requirements.

This course is suitable for anyone who is jointly or fully responsible for regulatory compliance and working in an organisation involved in any aspects of medical device manufacturing, designing, marketing or the supply chain and wants to understand and be able to apply the requirements of the new regulation (EU) 2017/745.

Topics covered on the course include:

  • scope and definitions
  • regulation governance actors
  • classification
  • conformity assessment procedures
  • quality management system requirements
  • technical documentation
  • general safety and performance
  • risk management
  • clinical evidence requirements
  • post-market surveillance and vigilance
  • identification and traceability
  • supply chain requirements
  • notified bodies

This course is structured to cover the following modules:

  • WELCOME AND REGISTRATION
  • Section 1 Introduction
  • Section 2  Scope & Definitions
  • Section 3 Regulation Governance Actors
  • Section 4  Classification
  • Section 5 Conformity Assessment
  • Section 6 Quality Management System
  • Section 7 Technical Documentation
  • Section 8 General Safety and Performance Requirements (GSPR)
  • Section 9 Clinical Evaluation and Clinical Investigations
  • Section 10 Post-market Surveillance, Vigilance and Market Surveillance
  • Section 11 Risk Management
  • Section 12 Identification and Traceability
  • Section 13 Supply Chain & Economic Operators
  • Section 14 Notified Bodies & Competent Authorities
  • Section 15 Transition and next steps
  • Section 16 Summary & Tools
  • CLOSE

By the end of this MDR training course delegates will be able to:

  • apply the requirements of (EU) 2017/745
  • explain the European regulation CE marking approach for medical devices, including its legal and operational basis
  • describe the structure and scope of the MDR, including classification and conformity routes
  • review the safety and performance requirements checklist applicable to CE marking under the new regulation
  • understand the new requirements when creating technical documentation to support the product throughout its life cycle
  • understand the level of clinical evidence necessary to demonstrate conformity
  • know how to develop a robust and proactive post-market surveillance system under the new MDR, including vigilance reporting and monitoring
  • identify the regulatory significance of a robust quality management and risk management system
  • gather the business impacts of the regulation and start to develop a transition plan.