Medical Device Regulation (MDR): Intro for Device Designers

Name: Medical Device Regulation (MDR): Intro for Device Designers
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An introduction to the EU's Medical Device Regulation (MDR) for those involved in developing medical devices

Created byJames Holmes

Last updated 6/2023

English

What you'll learn

The overall requirements and structure of the Medical Device Regulation (MDR)
Understanding the structure and content of the related international standard on Medical Device Software EN 62304
Understanding the structure and content of the related international standard on the Application of Risk Management to Medical Devices ISO 14971
What are the general safety and performance requirements set out in the MDR

Course content

4 sections • 9 lectures • 1h 3m total length

Course Overview1:11
This video provides a short overview of the series and introduces the topics covered.

Introduction, Medical Devices Definition, Claims & Standards3:32
In this first part of the series, we introduce the Medical Device Regulation itself, talk about what counts as a medical device, what claims you can make about them and how their development relates to international standards
General Obligations on Manufacturers4:20
In this part of the series, we look at Article 10 of the directive which sets out 16 general obligations on manufacturers.
Traceability Classification and Notified Bodies5:57
In this part of the series, we take a look at requirements for traceability of devices via the UDI system, how devices are classified depending on their risk level, and introduce the role that notified bodies play in device development.
General Obligations on Manufacturers Quiz

Clinical Evaluations and Clinical Investigations5:15
In this part of the series we look at clinical evaluations, understand the objectives behind them and look at what is needed to conduct them.
General Safety and Performance Requirements8:09
In this part of the series, we look at the General Safety and Performance Requirements of the Medical Device Regulation. We cover how they are structured, go through many of the more general requirements in some detail and also look at how we are expected to show our compliance with them.
Technical Documentation3:20
In the process of developing any Medical Device, we generate a lot of documentation, fortunately the Medical Device Regulation sets out a clear structure for Technical Documentation and we take a look at it in this video.

Software in the MDR & an Introduction to IEC 6230413:50
Software is playing an increasingly important role in medical device development and we’re seeing more and more Apps or other standalone software entering the market as medical devices in their own right. This coupled with the increasing application of artificial intelligence and machine learning to solve medical challenges mean that software applied to medical devices is an evolving topic and continues to see updates to how it is regulated. In this video we take a look at what the MDR has to say about software and what this means for medical device development.
Software in the MDR & IEC 62304
Risk Management in the MDR & an Introduction to ISO 1497118:15
Risks are mentioned almost 250 times in the Medical Device Regulation and risk management is the process of applying a defined and methodical approach to managing these risks to ensure that products are safe to use. In this video we take a more detailed look at what the MDR has to say about risk management and how these relate to ISO 14971 which is the international standard on the Application of risk management to medical devices.
ISO 14971 Key Points

Requirements

An interest in the design and development of medical devices

Description

Welcome to this short video series introducing the European Union's Medical Device Regulation (MDR). If you’re involved in the design and development of medical devices and are looking to get up to speed on this current regulation hopefully you’ll find this series useful.

What's In

We run through a lot of the topics covered in the MDR starting at what specifically count as medical devices, what rules govern the marketing claims which can be made about them and how development for the MDR relates to international harmonised standards. We introduce a lot of the obligations placed on us as designers and manufacturers including technical documentation, traceability, risk management and a lot of other content I hope you’ll find useful. We also signpost where you can find more detail on each topic as we go along.

What out

In this series, we focus more on aspects of the MDR relevant to design and development of devices in preparation for sale rather than, distribution, post market requirements, or the requirements placed on notified bodies which are also covered in the MDR.

Who's it for?

Whether you’re just getting started in the medical device industry or looking to get up to date on this latest regulation, hopefully you will find this series useful and it will help take your learning to the next level.

Who this course is for:

Engineers and designers looking to learn more about the EU's Medical Device Regulation (MDR)

Medical Device Regulation (MDR): Intro for Device Designers

What you'll learn

Explore related topics

Course content

Course Overview1 lecture • 1min

Overview and General Requirements3 lectures • 14min

Safety & Performance Requirements, Clinical Evaluation & Technical Documentation3 lectures • 17min

Focus on…2 lectures • 32min

Requirements

Description

Who this course is for: