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 industry leading experts have created a 2-day 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.
This course is fully interactive and offers you the chance to ask questions, take part in group activities, participate in polls and share and download course materials.
- History, purpose and structure of the MDR
- Key terminology and definitions
- EU-MDR timelines for transition
- Devices in and out of scope
- MDR main changes
- Non-Medical devices
- Placing a device on the market
- Manufacturer’s articles & obligations
- 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
- The General Safety and Performance Requirements
- Chapter I General Requirements
- Risk Management
- Chapter II Design & manufacture requirements
- Chapter III Device Information
- Clinical Evaluation requirements
- Post Market Surveillance
- Summary of Safety and Clinical Performance
- Clinical Evaluation and PMCF
- Annex II and Annex III Technical documentation
- Unique Device Identification (Annex VI)
- UDI Timelines
- Overview of Eudamed
Date: 12 - 13 October, 2021
Location: Live online classroom
Day 1: 9:00am - 16:00pm
Day 2: 9:00am - 16:00pm
The certification you will earn can be used to demonstrate your knowledge to your employers and Notified Bodies.
Who should attend?
This training course is recommended for anyone making and selling devices into the European Union:
- Regulatory Affairs Professionals
- Research and Design Engineers
- Quality Managers
- Quality Engineers
- Authorised Representatives
What will I receive?
▪ PDF training course notes, slides and handouts
▪ PDF Indexed copy of the EU MDR
▪ 15% discount on the brand new 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!
"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."
"I really enjoyed this course and took a lot away from it, Rod is an excellent tutor. I now know what I need to do for our MDR transition! I have recommended this course to my colleagues, thanks again"
"Thanks a million, the course was excellent and very enjoyable!"
"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"