Construction of a Technical File in Line with MDR Training Course 

Agenda

This one-day training course will introduce the architecture of Technical File and will outline the process steps  for implementing an effective Technical File in line with MDR requirements. 

A CE Marking Technical File  is a comprehensive description of your device intended to demonstrate compliance with European requirements (2017/45 or 2017/746). Compiling your technical file is a requirement for compliance with the Medical Devices Regulations

Module 1. What is a Technical File 

Module 2  Generic Structure of Technical File

Module 3  Article 52 of MDR 2017/745 Requirements

Module 4    IMDRF/RPS WG/N9 FINAL:2019 Review

Module 5   Annex II and Annex III of the MDR 2017/745

Module 6 General Safety and Performance Requirements (GSPR) Annex 1 MDR 2017/745 compliance Conformance

Module 7  Risks

Module 8 Post Market Surveillance

Module 9 PSUR

Module 10 Verification and Validation

Module 11  Design

Module 12 Clinical Evaluation

Module 13 Declaration of Conformity (DoC)

Module 14  Interconnectivity of product Claims clinical evidence and Design 

Module 15  Who is reviewing Technical file 

Learning Objectives

Delegates attending this Construction of a Technical File in Line with MDR Training Course will be able to:

• Understand the architecture of a Technical File
• Understand the process for a gap analysis and what is required to put in place a Technical File for your product
• Understand regulatory requirements around Technical File submissions