Medical Device Regulation (EU MDR) 2017/745

VIRTUAL CLASSROOMS

Course Overview

 

The Medical Devices Regulation (EU 2017/745) has replaced the Medical Devices Directive (93/42/EEC) as the legislation detailing the requirements that manufacturers must comply with in order to place medical devices on the market within the European Union.

Our industry leading experts have created a 2-day course to help you understand the additional requirements of the standard, so you know what you need to do for your business and products to meet the new MDR.

This course is fully interactive and offers you the chance to ask questions, take part in group activities, participate in polls and share and download course materials.

Course Agenda

Module 1

- History, purpose and structure of the MDR

- Key terminology and changes

- EU-MDR Timelines for transition

- Devices in and out of scope

- Non-Medical devices

Module 2

- Overview of Chapter II

- Articles 5-9 & 16-24

- Economic Operator & PRRC Responsibilities

Module 3

- Overview of Annex VIII

- Class Types & Classification Rules

- Custom Made Devices

- Notified Body Articles & Annexes

Module 4

- Annexes IX, X, XI

- Overview of Annex I

- Chapter I General Requirements

- Risk Management

- Chapter III Device Information

 

Module 5

- Clinical Evaluation requirements

- Overview of PMS Articles 83-86

- Overview of Vigilance Articles 87-89

Module 6

- Annex II and Annex III Technical documentation

- Unique Device Identification (Annex VI)

- UDI Timelines

- Overview of Eudamed

Date: 6 - 7 July, 2021

Location: Live online classroom

Day 1: 9:00am - 16:00pm

Day 2: 9:00am - 16:00pm

The certification you will earn can be used to demonstrate your knowledge to your employers and Notified Bodies.

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Who should attend?

This MDR training course has great value for anyone involved in implementing or maintaining a QMS.

▪    Quality Assurance professionals

▪    Quality Engineers

▪    Research and Design Engineers

▪    Internal Auditors

▪    Quality Managers

▪    Manufacturing Engineers

▪    Regulatory professionals

What will I receive? 

▪    PDF training course notes, slides and handouts 

▪    PDF MDR training course certificate 

▪    PDF Indexed copy of the EU MDR 

▪    15% discount on the brand new MDR Guidebook

▪    The opportunity to get your questions answered! 

▪    Full tutor support 

Don't just take our word for it - take a look at just a few of our virtual classroom attendee reviews! 

Eleanor Shackleton

Opera Care

 

"Thank you for providing me with a high level overview of the Medical Device Regulation 2017/745, the course has helped me to understand what I need to do in order to transition the business from the Medical Device Directives (93/42/ECC), I would highly recommend this course." 

David Jacobs

Consultant

 

"I really enjoyed this course and took a lot away from it, Rod is an excellent tutor. I now know what I need to do for our MDR transition! I have recommended this course to my colleagues, thanks again" 

Carolyn Boughton

GS Medical

 

"Thanks a million, the course was excellent and very enjoyable!"

Angelina Horton 

Consultant

 

"I have learnt a lot from this course and it is excellent to get insights and advice from the experts, thank you. I particularly enjoyed the Q&A session"