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Fundamentals of the EU Medical Device Regulation (MDR)

31 March 2022 | 2 Week Live Online Course

£790.00

Register for the Introductory Module Free

Gain a comprehensive overview of the Medical Device Regulation (MDR) to ensure device compliance in the EU.

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Enrol before | 18 February to save £410 | 18 March to save £210

 

 

Course Overview

 

The EU introduced the Medical Device Regulation (MDR) to replace the Medical Device Directive (MDD). The aim of the MDR was to significantly improve patient safety throughout Europe with more stringent guidelines. This meant major regulatory changes for all involved in the industry including manufacturers, importers, distributors, Regulators and Notified Bodies.

 

This course will provide you with a comprehensive understanding of the EU MDR requirements from device classification and conformity assessment routes to clinical requirements and post market factors. By examining a broad range of topics, you will develop a deep knowledge of the MDR and its impact throughout device development and distribution. This course has been specifically designed for those new to Medical Devices, the MDR or experienced professionals changing roles.

 

With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live classroom training.

 

What is included in a live online course?
  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Bitesize learning
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 4 weeks after the last session
  • Full access to the Educo Post Learning Implementation Plan (PLIP)
  • A validated certificate of attendance available for you to download and file

Learn more about how we deliver live online training

Frequently asked questions (FAQs)

 

Key Learning Objectives

 

  • Examine the role of key stakeholders including device manufacturers, distributors, Notified Bodies and Competent Authorities
  • Understand the new regulatory requirements under the MDR to remain compliant in Europe
  • Learn how to classify your device with case study examples
  • Review the General Safety and Performance Requirements (GSPRs) for devices and the role of standards to demonstrate compliance
  • Examine the conformity assessment routes under the MDR to get your device certified in Europe
  • Understand the requirements for clinical evidence including clinical evaluations, investigations and Post Market Surveillance (PMS) and vigilance
  • Examine the importance of ISO 14971 device risk management and how it links to clinical evaluations and PMS
  • Understand the importance of ISO 13485 Quality Management System (QMS)
Post Learning Implementation Plan (PLIP)

Pre-course

  • Access to the Educo Training Portal
  • Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

  • At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

  • Delivered 3 to 4 weeks after the training
  • It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges
Introductory Module 1

FREE to Attend | Live & Recorded

1 March | 60 mins | 12 PM (UK)

Introduction to Medical Devices and the New MDR and IVDR

  • Definitions and actors
  • Competent Authorities and Notified Bodies
  • Economic operators – obligations of manufacturers, distributors, importers and authorised representatives
  • Placing on the market and enforcement
  • Introduction to the MDR & IVDR and reasons behind their development
  • Chief differences of MDR with MDD and impact of MDR on industry
  • What isn’t covered in the regulations?
  • Eudamed database/GMDN

 

Register For Module 1 | Free

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Module 2

31 March | 120 mins | 12 PM (UK)

Medical Device Classifications

  • Review of definitions
  • Principles of classification – MDR – The 22 Classification Rules
  • Borderline determination
  • Risk classes and practical examples
  • Annex XVI devices
  • Examples of device classification

 

Classification Exercise
In groups you will apply the MDR classification rules to various medical devices to determine what class they are. Once completed you will discuss your answers with the class.

 

Conformity Assessment Routes

  • Examination of the possible conformity assessment routes
  • Analysis of the routes defined by the MDR
  • What is required for each Conformity Assessment Annex?
  • Additional scrutiny requirements under MDR
Module 3

1 April| 120 mins | 12 PM (UK)

General Safety and Performance Requirements

  • GSPRs – technical requirements – role of standards in demonstrating compliance with GSPRs
  • Chief differences with the MDD
  • Labelling requirements – impact of Unique Device Identification and registration on EUDAMED

 

GSPR Exercise
In groups you will examine a GSPR that is applicable to your device and complete the details of how you will meet it. Once completed you will discuss your answer with the class.

Module 4

5 April | 120 mins | 12 PM (UK)

Technical Documentation and other regulatory aspects of the QMS

  • Annex II of MDR – Technical file format / structure
  • Annex III – Post-Market Surveillance documentation
  • Good documentation practice
  • Inclusion of regulatory processes in the Quality Management System
  • Requirements for the Person Responsible for Regulatory Compliance
Module 5

6 April | 120 mins | 12 PM (UK)

Clinical Evaluation, Post Market Surveillance (PMS), Post-market Clinical Follow Up (PMCF) & Vigilance

  • Overview of the specific regulations and guidance
  • Definitions
  • Clinical evaluation process
  • PMCF within the context of clinical evaluation and PMS
  • Understanding the cyclical nature of post-market surveillance with all its interfaces
  • Post- market surveillance requirements and key output documents
  • Vigilance reporting requirements
Module 6

7 April | 120 mins | 12 PM (UK)

Risk Assessment and Management

  • Risk Management concept and EN ISO 14971:2019
  • Risk Management process and linkage of clinical evaluation, PMS with risk conclusions.
  • Key output documents
  • Risk Management Plan
  • Risk Benefit Analysis
  • Risk Management Report

 

Risk Assessment Exercise
Working in groups or individually you will examine your understanding of risk management by completing a case study exercise. Once completed you discuss your answers with the class.

Anne Jury is a consultant and trainer in medical devices EU & UK regulatory compliance and quality assurance systems.  Starting out as company microbiologist for Smith & Nephew Textiles Anne went on to work for Notified Bodies, BSI and then TÜV Product Service as a lead auditor and later as UK Regional Manager.

 

Anne has run her own consultancy business since 2000 providing medical device regulatory support to companies ranging from research institutes and start-up companies to SMEs and multi-national market leaders.  Anne was one of the founders and visiting lecturers to the MSc in Medical Technology Regulatory Affairs run by TOPRA and Cranfield University where she was also external examiner from 2009 to 2012.

 

Anne has extensive MDR expertise, supporting her clients transition from the MDD as new guidelines and ISO standards are published. As a result, she can draw on multiple case study examples and experience when delivering MDR training courses. Anne has led both in-house and public courses on medical device EU regulatory affairs for several years.

 

Anne is also Vice-President of Team-PRRC, a non-profit organization set up in March 2020 to support individuals in the role of PRRC under the EU medical device regulations.

This course is suitable for professionals who work in or are new to the Medical Device industry and require a complete overview of the Medical Device Regulation (MDR). These include: Regulatory Affairs | Quality | Design & Development | Clinical | Management | Device Manufacturers | Device Distributors | Pharmaceutical Professionals new to Device regulations.

 

Could your team benefit from this course?

 

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

Or please summarise your objectives by completing the form below.

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• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• For live online courses, dates and times of modules are subject to change
• Please ask for the module dates and times of subsequent live online courses planned later in the year
• For live online courses, module durations are approximate
• For classroom courses, venue details will be provided