EU Medical Device Regulatory Affairs explained Simply

👩‍⚕️ How to Get Approval to Sell Medical Devices within the European Union: Understand Regulatory Affairs & ISO 13485 2016

🚀 Course Headline: Master the intricacies of EU Medical Device Regulatory Affairs with our comprehensive online course! Dive into the world of regulatory affairs and gain a deep understanding of ISO 13485 2016 standards to secure market approval in Europe. Whether you're a newcomer to the industry or looking to expand your knowledge, this course is tailored to guide you through every step.

📚 Course Description: Are you aspiring to navigate the complex landscape of EU medical device regulations? Or perhaps you're an established professional seeking to update your skills in line with the latest MDR and IVDR requirements? Our online course, explained in a simple yet comprehensive format, is designed to help you achieve just that. With each lecture meticulously crafted for clarity, this module serves as an indispensable resource for anyone involved in medical device regulation, start-ups, or the broader industry sectors such as operations, quality, engineering, marketing, and research/development.

Whether you're a student aiming to grasp the rules governing medical device sales within the EU marketplace, a manufacturer outside the EU looking to enter the European market, or simply someone interested in understanding the importance of ISO 13485 2016 for market approval—this course has got you covered.

🔹 Key Topics Covered:

• 📚 Understanding the Framework: Difference between Regulation and a Directive.
• 🗺️ Navigating EU Approval Processes: Steps required to get permission to manufacture and sell a medical device in Europe.
• 🛠️ Identifying Authorities: Competent authority and Notified body roles.
• 📈 Directives Deep Dive: MDD 90/385/EEC, MDD 93/42/EEC, and the directive of In Vitro Diagnostic Medical Devices (98/79/EEC).
• ⚖️ Modern Regulations: MDR EU 2017/745(MDR) & EU 2017/746 (IVDR).
• ✅ CE Marking Essentials: Approval process and requirements.
• 🔧 Device Classification: Including the MDR 2017 745 classification.
• 🌍 Quality Management Systems: ISO 13485 2016 standards.
• 🤝 Roles and Responsibilities: Understanding the relationships between manufacturers, authorized representatives, and the EFTA.
• 🎓 Real-World Application: Brexit and its impact on EU regulations.
• ⏳ Transitioning Regulations: Understanding the timeframes from directives to the medical device regulation (MDR).

🧐 Interactive Learning: Each lecture concludes with a quiz designed to reinforce key learner outcomes, ensuring you fully comprehend and retain the material. This interactive approach not only enhances your learning experience but also prepares you for real-world regulatory challenges.

Enroll today and take the first step towards mastering EU Medical Device Regulatory Affairs! 🌟