Course overview

Combination Products
for Medical Devices

In the EU, the demarcation between medical devices and medicinal products and the appropriate regulatory route to approval is becoming more and more complex thanks to the emerging new technologies that challenge the borderline space.

This 6-hour course outlines the European requirements for combination products, giving you a clear understanding of
 the borderline area and helping you define the regulatory route for your product. You'll also gain insight into the Medical Device CE certification conformity assessment process, as well as Notified Body expectations for Devices containing ancillary medicinal substance and Devices containing ancillary human blood derivative. Get to know the Competent Authority Medicinal Consultation process, the options available, timelines and documentation expectations,  Post-CE certification expectations and change management.

This course is delivered virtually using Zoom and is fully interactive, offering you the chance to take part in group activities, participate in polls and download course materials.
Format 

Virtual
Instructor-Led

Date / Time

Select your date below 

Price

€585

Duration

6 Hours

Time

1pm - 4pm

Time Zone

GMT

Course Information

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

We're currently finalising our 2024 course calendar. Register your interest below to be the first to receive new dates! 

Training Times

1 pm - 4 pm GMT
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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
  • Introductions
  • Medical Device & Medicinal product Borderline Area
  • Classification
  • Key definitions
  • Differences in the regulatory approval process 
  • Conformity Assessment process
  • Q&A


Day 2

  • Key Stakeholders – Roles and Responsibilities 
  • Documentation expectations for the CA / EMA Consultation
  • Common gaps in development data 

Learning Objectives

  • Gain an appreciation of the borderline area between medical device and medicinal products in the EU
  • Understand the importance of correct regulatory classification and differences in regulatory requirements for medical devices and medicinal products
  • Understand the CE Certification process for a medical device with ancillary medicinal substance / human blood derivative
  • Appreciate the roles and responsibilities for all stakeholders involved in the process
  • Understand the documentation requirements for such a device

Who Should Attend? 

This course is recommended for those in the medical device industry who are interested in medical devices incorporating 'medicinal or human blood derivative' ingredients, such as Development Scientists or Regulatory personnel.

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.

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Witness it first hand, directly from our previous attendees 
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Meet your instructor

Theresa Jeary

Trainer & Consultant

Theresa holds a master’s degree in Pharmaceutical Science from the Royal College of Surgeons, Ireland and is eligible to be a Pharmaceutical Qualified Person. She has over 30 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle from product concept and early stage development, process transfer, validation and regulatory departments.

In addition to her product development and global regulatory expertise, Theresa has over 12 years' Notified Body experience, first at BSI as a technical expert for devices with ancillary medicinal substance and borderline classifications moving then to LRQA where she held the role of Head of Notified Body for several years.
More recently Theresa has worked as a consultant to the medtech sector assisting Manufacturers in their product development and supporting them in navigating their legal requirements and changes to the Medical Device Regulations.

Theresa is a regular presenter on combination products and Article 117 and regularly contributes to various scientific publications and regulatory guidance and has extensive experience of interacting with EU Competent Authorities.  
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 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 - 4 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 get started?