Embark on a comprehensive journey into the complex world of the EU Medical Devices Regulation (MDR) with our introductory training course.
Embark on a comprehensive journey into the complex world of the EU Medical Devices Regulation (MDR) with our introductory training course. Over the course of four hours, subject matter expert Kamelija Milosev will take you through the core principles and procedural elements of Regulation (EU) 2017/745 on Medical Devices.
This course will give you a foundational understanding of the EU MDR and its classification criteria, conformity assessment and registration procedures, and post-market surveillance requirements – including a summary of all related compliance deliverables. We will also help you to make sense of the intricate timelines and compliance deadlines as a result of the transition from the Medical Device Directive (MDD) to the EU MDR.
Whether you are new to regulatory affairs or seeking to enhance your understanding of the latest regulations, this course will equip you with the tools and strategies needed to ensure medical device safety, quality and above all, regulatory compliance.
We will also discuss the recent EP resolution urging the Commission to revise the MDR/IVDR in 2025.
What can you expect from the course?
- A comprehensive overview of the key elements of the EU Medical Devices Regulation (MDR)
- A step-by-step approach to EU MDR compliance
- A summary of relevant implementation deadlines and any changes
- A list of deliverable documents for demonstrating compliance with the EU MDR
Who should attend this course?
- Medical device manufacturers, importers, distributors and/or authorized representatives
- Regulatory affairs professionals
- Quality assurance personnel
- Compliance managers
- Regulatory affairs managers
- Healthcare professionals involved in medical device procurement and use
- Anyone wishing to develop a deeper understanding of the medical device regulatory framework in the EU
Is this a key topic of interest for your business? We can run this training course exclusively for your organization, as a tailored learning experience. Email us at events@chemicalwatch.com for more information