Medical Device Regulation (EU MDR) 2017/745
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 two day online instructor-led MDR training course has been created to help medical device manufacturers understand the additional requirements of the standard, so you know what you need to do for your business and products to meet the regulation.
Our expert trainers will take you through the MDR, not just from an industry perspective, but also from a Notified Body perspective, which means you get the benefit of understanding what both sides are looking for.
Unlike many other online trainings, we encourage you to bring and ask as many questions as you like! This is the best way to embed your knowledge and get a thorough understanding of the new regulation. We are here to help you make your medical devices compliant.
This course is fully interactive and offers you the chance to take part in group activities, participate in polls and share and download course materials.
▪ Introduction to the EU MDR
▪ Medical Devices covered by the EU MDR
▪ Placing a device on the market
▪ Device Classification
▪ Unique Device Identifiers (UDI)
▪ Routes to Conformity
▪ Clinical Data Evaluation
▪ Technical File documentation
▪ GSPR & Risk Management
▪ Post Market Surveillance & Vigilance
You have the opportunity to ask as many questions as you like to our expert trainers throughout the course.
Day 1: 8:30am - 16:30pm
Day 2: 9:00am - 16:30pm
Due to the nature of the course, an exact time of each topic can not be provided.
The certification you will earn can be used to demonstrate your knowledge to your employers and Notified Bodies.
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 Indexed copy of the EU MDR
▪ 15% discount on the 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!