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New Regulation for Medical Devices (EU) 2017/745 MDR: General Introduction and Principles. Special requirements for Manufacturers/ Technical Documentation

Duration

10 Hours over 3-Day

Day 1: 8 AM - 11 AM ET 

Day 2: 8 AM - 11 AM ET

Day 3: 8 AM - 12 PM ET

   

Course Fee

  • $1,526.00 USD if register 30 Days prior to the start date
  • $1,695.00 USD Original Pricing

   

Certificate

Participants will receive the below certificates at the conclusion of the course. All certificates are issued by TUV USA.

Certificate of Attendance to the attendant who participates in the entire course.

Course Overview

This 3-Day, 10 Hour training is to provide a general introduction and principles. The course will cover special requirements focused on Manufacturers/ Technical Documentation.

General information:

-The concept and policy behind the Regulation

-The “Life Cycle” approach

-The status (after full implementation on 26 May 2021)

    

Course Objective

Part 1

  1. General principles of the Regulation on Medical Devices (EU) 2017/745 MDR and the critical points of differentiation from MDD 93/42 / EEC.
  2. New concepts and definitions,
  3. Devices without a Medical Purpose subject to the requirements of the Regulation
  4. New Product Classification Rules - cases of classification upgrade.
  5. Person Responsible for Regulatory Compliance
  6. Topics related to Product Life Cycle monitoring and Reporting (Post market Surveillance-PMS, PSUR, Summary of Safety and Clinical Performance SSCP etc.)
  7. European database for medical devices (EUDAMED / SRN), UDI requirements, Implant cards, the new EMDN nomenclature etc.
  8. Requirements for the manufacturers of product systems and procedure packs
  9. "Legacy devices" in accordance with Article 120(3) and the transitional provisions of the Regulation.

 

Part 2

    1. Technical Documentation requirements
      1. Annex II (Technical Documentation requirements) & examples related to General Safety and Performance Requirements (GSPR)
      2. Annex III (Post Market Surveillance Plan) and PMS reporting
  1. Clinical Evaluation, PMCF plan, PMCF studies-report
  2. Relation of Technical Documentation with QMS

   

Who Should Attend?

  • Persons Responsible for Regulatory Compliance,
  • Quality Management Officers,
  • Regulatory Officers and executives of medical technology companies, as well as to any professional in the field of medical devices.Persons Responsible for Regulatory Compliance, Quality Management Officers, Regulatory Officers and executives of medical technology companies, as well as to any professional in the field of medical devices.

   

Pre-requisites

The attendee shall have a basic knowledge of medical device industry.

   

Trainers

Georgios Melachrinos

TUV HELLAS (TUV NORD)

E-mail:  gmela@tuv-nord.com 

 

Tarsi Giannouli

Physics BSc, Biomedical Engineering, MSc, DIC

Deputy Manager PC Medical

TUV HELLAS (TUV NORD)

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