Course overview

Medical Device Regulation (EU MDR) 2017/745

The MDR (EU 2017/745) has replaced the MDD (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 EU.​

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

The certification you will earn from this training can be used to demonstrate your knowledge to your Employers and Notified Bodies.
Format 

Virtual
Instructor-Led

Date / Time

Select your date below

Price

€1,100

Duration

16 Hours

Time

1pm - 5pm

Time Zone

GMT

Course Information

Dates & Prices
Course Syllabus 
What's Included
Technology Requirements
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Training Dates

Training Times

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Discounts 

Group booking discounts are available as followed:

• 3 – 5 attendees receive 15% discount
• 6 or more attendees receive 20% discount

Email our team at [email protected] and one of the team will provide you with your unique discount code or invoice. 

More than 8 attendees?

If there are more than 8 people from your organization that would like to take this course, consider arranging an in-house training. The price can often work out cheaper, and the course can be customized to your exact needs.

What Is Included?

▪    Direct, live access to an expert trainer
▪    Access to the Meddev Solutions Training Portal
▪    Fully Interactive Course - Polls, quizzes and breakout sessions 
▪    Downloadable Resources 
▪    CoE Accredited Certificate of Completion
▪    Knowledge Checks
▪    Full Tutor Support 

Course Agenda

This training course will explore the following topics:

Day 1:
  • History, purpose and structure of the MDR
  • Key terminology and definitions
  • EU-MDR timelines for transition
  • Brexit
  • Devices in and out of scope
  • MDR main changes Non-Medical devices
  • Placing a device on the market
  • Manufacturer’s articles & obligations


Day 2:
  • Economic Operator & PRRC Responsibilities Declaration of conformity
  • Procedure packs, spares and components
  • CE Marking
  • Overview and structure of the classification Annex VIII
  • Class Types & Classification Rules
  • Notified Body certificates
  • Routes to conformity

Learning Objectives

  • Understand the history, purpose and structure of the MDR
  • Be able to identify the types of devices covered by the MDR and the rules for classifying these devices
  • Understand the obligations of the manufacturer, economic operators and the PRRC            
    Understand the GSPRs and key features of a risk management system based on ISO 14971
  • Describe the contents of the Technical Documentation and the requirements for PMS, Vigilance and Clinical Data
  • Explain the UDI requirements and the relationship with Eudamed

Who Should Attend? 

This training course is recommended for anyone making and selling devices into the EU:

  • Regulatory Affairs Professionals
  • Research and Design Engineers
  • Quality Managers
  • Quality Engineers
  • Authorised Representatives
  • Consultants

Technology Requirements

Operating system
Windows requirements: Windows 7 or later
Mac requirements: Mac OS X Yosemite 10.10 or later
Linux requirements: 64-bit, Ubuntu 14.04+, Debian 8+,openSUSE 13.3+ or Fedora Linux 24+

Processor
Windows requirements: Intel Pentium 4 or later
Mac requirements: Intel
Linux requirements: Intel Pentium 4 or later

Internet connection
Required

Zoom

We use Zoom for our virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.

Get your training agenda

Simply fill in the form to access your training agenda now.

Don't just take our word for it

Witness it first hand, directly from our previous attendees 
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"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." 

Eleanor S

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

Carolyn B

GS Medical
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"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"

Angelina H

Freelance Consultant 
Meet your instructor

Dr Steve Curran

Senior QA/RA Expert & Trainer 

Dr Steve Curran is Senior QA/RA Expert at Meddev Solutions.
Steve holds a PhD in Clinical Engineering, and has worked as a research engineer, project manager and a regulatory and quality assurance professional. With an extensive background in manufacturing process engineering, medical device design and global regulatory and quality affairs for the medical device industry, he has significant experience managing projects from concept to completion as a senior leader.

His career has been truly global. Steve spent five years in managerial positions, before working as Lead Technical Auditor with a major Notified Body for eight years. More recently, he worked as Head of Regulatory & Quality Affairs at a medical device company, before ultimately spending three years as Compliance Director in the area of orthopaedics.

Steve brings a wealth of experience to this role, with significant involvement in auditing and compliance. He has also presented at a number of international conferences on biomaterials, tissue engineering and regenerative medicine and has published several peer reviewed papers in these areas.
Rod Beuzeval

Training for your team,
your way

We understand that every company is different and face unique challenges everyday. At Meddev, we can tailor any of our courses around your organisation’s specific needs and products. 

Bespoke learning experience

Develop your course with a leading subject matter expert to meet the specific needs of your organisation

Maximise your budget

Cut unnecessary costs and allocate your budget on what matters most

Track employee progress

Keep track of your employees’ progression in your own workspace

Get your training agenda

Frequently asked questions

When will I receive the course confirmation details? 

Once your booking has been placed and confirmed, you will receive an email which contains your account login details. You can access your payment receipts, course details, learning materials and more in your account! 

What is included in the course?

▪ Direct, live access to an expert trainer
▪ Access to the Meddev Solutions Training Portal
▪ Fully Interactive Course - Polls, quizzes and breakout sessions
▪ Downloadable Resources
▪ CoE Accredited Certificate of Completion
▪ Knowledge Checks
▪ Full Tutor Support 

Is this course live?

Yes! This course is completely live with a Centre of Excellence approved industry-expert. You can ask questions throughout the course as if you were in a real classroom. 

What time is this course?

We run this course from 1 pm - 5 pm GMT. If you can't make the live sessions, don't worry. We will record them, so you can catch up on anything you've missed!

Do I get a course certificate?

On successful completion of the course, you will receive a certificate of completion that can be used to demonstrate your knowledge to your employers and Notified Bodies. 

What payment methods do you accept?

The fastest and easiest way to pay would be to use your company credit card. If you cannot do that, and you require a PO, please email our team at [email protected]

Do you offer group booking discounts?

Absolutely! 3 – 5 attendees receive a 15% discount and 6 or more attendees receive a 20% discount. If there are more than 8 people from your organization that would like to take this course, consider arranging an in-house training. The price can often work out cheaper, and the course can be customized to your exact needs.

Can I transfer my place to another colleague?

Yes of course. If you can no longer attend the course, you can transfer your place at no additional cost.

What application do you use for the training?

We use Zoom for our virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
Ready to upskill on the MDR?