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Fundamentals of the EU Medical Device Regulation (MDR)

9 & 10 November 2022 | Hybrid | London

£1,095.00£1,295.00

The price is for both days | Register for Online 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 | 21 September To Save £400 | 21 October To Save £200

Discount is applied to the price above. VAT, if applicable, will be added. The full price for the classroom option is £1,495 and live online is £1,295.

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 classroom and live online training. If you have any concerns about COVID-19 before registering on to the course, please read our COVID-19 commitment.

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 to 5 weeks after the last session
  • Reinforcement session delivered 4 to 5 week after the course (online) providing you with extra time with the trainer
  • A validated certificate of attendance available for you to download

Frequently asked questions (FAQs)

What is a Hybrid Training Course?

 

You decide what format is best for you. The course is delivered as a classroom (in-person) course that is also delivered online. You can decide whether you would like to attend in person or online. The price is dependent on the option.

 

We recommend visiting our website to learn more. Click here to learn more about hybrid training at Educo Life Sciences.

Register For Free Online Session

 

There are limited spaces on the introductory session. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.

What is Included in a Classroom Course?

 

  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Refreshments and lunch provided on each day
  • Reinforcement session delivered 4 to 5 week after the course (online) providing you with extra time with the trainer
  • A validated certificate of attendance available for you to download
  • Access to the Educo Life Sciences Training Portal before and after the course for additional learning materials

 

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)

Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)

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

| 60 mins |

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

There are limited spaces on module 1. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.

Module 2

| 120 mins | 

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

| 120 mins | 

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

| 120 mins | 

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

| 120 mins | 

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

| 120 mins | 

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

Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)

Classroom Training Information

The training starts at 9.00 am UK time and finishes approximately 4:00 pm / 5:00 pm on each day. The final day may start and finish earlier to accommodate peoples travel arrangements.

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 Online Module
FREE to Attend | Live & Recorded

15 September | 60 mins | 10:00 AM UK

Delivered Online

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

There are limited spaces on module 1. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.

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Day 1

9 November 2022

Introduction to the course, Medical Devices and the New MDR and IVDR

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

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.

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.

Day 2

10 November 2022

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

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

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

Most of our classroom courses are located at a venue in central London. The city has good transport links and is good place to socialise with fellow attendees. Accommodation is not included in the price. We recommend staying in a hotel within walking distance of the venue. Lunch and refreshments are included on all days where you will be able to interact with fellow peers and the trainers.

 

The course is held in the following venue:

Hallam Conference Centre, Cavendish Venues, 44 Hallam St, London, W1W 6JJ

 

Link to the Google Map

Free Online Module and Pricing

 

  • Module 1 is free to attend and is delivered online and is recorded.
  • To enrol onto module 1, please submit your details in the form.
  • Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.
  • There are price tiers for this course. The dates of these are at the located above the course overview.

 

Frequently asked questions (FAQs)

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.

Complete our contact form by following the link. Get in touch.

*

• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• In the event we do not have enough people on one of the options we will contact you to discuss switching. If for example we ask you to switch from classroom (in-person) to live online, we will refund you the difference in price.