Course overview

In Vitro Diagnostic Regulation 2017/746

The IVDR will replace the current EU Directive on in Vitro Diagnostic Medical Devices (98/79/EC) and will be effective in all EU member and EFTA states. This means that there are significant changes in requirements compared to the previous IVD Directive. Through this training, you'll gain clarity on exactly what has changed, as well as practical guidance for updating your quality system, economic operator oversight, labelling and technical documentation.  

Our industry-leading experts have created this 16 hour course to give you an appreciation for the changes and new requirements of the IVDR and provide practical skills and guidance on how to transition to the new regulation.

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:
  • Reasons for the IVDR
  • Structure and key changes of the IVDR
  • Key terminology and definitions
  • Introduction to CE Marking
  • Placing a device on the market
  • Manufacturer’s articles & obligations


Day 2:
  • Economic Operator & PRRC Responsibilities
  • Declaration of conformity
  • Overview and structure of the classifications
  • Annex VI - Class Types & Classification Rules
  • The General Safety and Performance Requirement
  • Routes to conformity

Learning Objectives

  • Understand the purpose and structure of the IVDR
  • Identify the types of devices covered by the IVDR and the rules for classifying these devices
  • Understand the requirements for manufactures and economic operators
  • Gain a solid understanding of the safety and performance requirements
  • Understand post-market surveillance and the associated reports
  • 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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"Thanks a million, the course was excellent and very enjoyable!"

Carolyn B

GS Medical
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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
on-demand webinar

IVDR State of Play: Transition Timeline Update, Classification and Conformity Assessment Activities

As the IVDR compliance deadline slowly creeps by, this free webinar explains how the framework is shaping up in terms of notified body capacity, transition timelines and guidance documents.


Guided by our regulatory experts, you'll understand the critical role that classification plays in the overall conformity assessment process, with a particular focus on GSPRs and performance evaluation.


Join now, and remember to share with a friend if you find it helpful!

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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 course overview, login details, course agenda and payment receipts. You can begin your training immediately!

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 IVDR?