Medical Device Regulation (MDR) (EU) 2017/745 Technical Documentation Implementation Training Course

This training aims to familiarise participants with the Technical Documentation requirements of Medical Device Regulation (MDR) (EU) 2017/745, understand what Notified Bodies are looking for and why Technical Documentation needs to be ‘live’ documents which cover the full product life cycle.

Course Content

• Introduction to Medical Device Regulation (MDR) and Technical Documentation
  • Looking at the definition of a medical device, understand what is impacting your Technical Documentation (TD) and why you need to keep your TD up to date, including general requirements associated with TD.
• Technical Documentation Content (Annex II)
  • Understanding the requirements for Technical Documentation according to Annex II, trying to prepare documents that are new for your company and for a dedicated product, thinking about UDI-DI and basic UDI-DI, classification and associated rationale.
• Technical Documentation Content (Annex III)
  • Learning to understand the requirements for Technical Documentation in Annex III, including post-market surveillance (PMS), the PMS Plan, PMS Report, and Periodic Safety Update Report (PSUR).
• Where to Start
  • Understanding the importance of performing a gap analysis, conducting a Technical Documentation review, defining the TD structure by identifying areas to focus on and understanding the need for a transition plan.
• Case Study
  • Take part in an interactive session to support your understanding and be able to implement the knowledge and skills learnt during the course. This will include tasks on product classification, technical documentation, an MDR gap analysis, team competencies, GSPR matrix and clinical evaluation assessment.
• How Notified Bodies Assess Technical Documentation
  • Become aware of specific areas that Notified Bodies will particularly focus on, understand the TD conformity assessment process described in Annex IX and learn about the assessment criteria that will be applied by Notified Bodies.

On completion of this course Learners will be issued with a "Certificate of Attendance"