IVDR 2017 746 regulatory affairs: Learn EU compliance

🎓 Master EU Compliance for In Vitro Diagnostic Medical Devices with IVDR 2017/746: A Step-by-Step Guide

🚀 Course Overview: This comprehensive online course, "IVDR 2017/746 Regulatory Affairs," is meticulously designed to simplify the complex EU regulations for Invitro Diagnostic Medical Devices (IVDDs). With clear, concise, and practical guidance, you'll gain a solid understanding of the requirements needed to achieve market approval in the European Union.

🔍 Course Structure: The course is structured into nine intuitive sections that systematically cover all aspects of IVDR compliance:

Section 1: Introduction to IVDR

• The introduction to IVDR 2017/746 and its significance.
• Understanding the shift from the old directive to the new regulation.
• Detailed transition timelines for a smooth move to IVDR.

Section 2: Economic Operators Explained

• A deep dive into the roles of European Authorised Representatives, Distributors, Importers, Manufacturers, and their obligations under IVDR.
• Clarifying when and how these responsibilities change.
• Emphasizing the importance of a person responsible for regulatory compliance.

Section 3: Understanding EUDAMED

• An introduction to EUDAMED, the EU Database for Medical Devices.
• A walkthrough on actor registration processes.
• Timelines for the transition and implementation of the EUDAMED system.

Section 4: Unique Device Identification (UDI) Registration

• Introduction to UDI and its necessity.
• Detailed explanation of the UDI carrier, including current accredited organisations.
• UDI timelines and how to attach it to devices and packaging.

Section 5: Classification of In Vitro Diagnostic Medical Devices

• Guidance on qualifying devices and determining if your product falls under IVDD.
• A clear understanding of IVD definitions, classification rules, and the impact of IVDR.

Section 6: Conformity Assessment Pathways

• A detailed guide to the conformity assessment routes for Class A to D devices.

Section 7: Sufficient Clinical Data & Safety Monitoring

• Insights into General Safety and Performance Requirements.
• Identifying the Intended Purpose of your device.
• Strategies for collecting sufficient clinical data and maintaining compliance through Clinical Evaluation and Post Market Performance Follow-up (PMPF).

Section 8: Post Market Surveillance

• A comprehensive look at post market surveillance requirements, including reporting and periodic safety updates.
• Understanding the role of Competent Authorities and the European Commission in market surveillance.

Section 9: Additional Topics & Considerations

• Discussing the Medical Device Coordination Group and its importance.
• Addressing Brexit and its implications for IVDD manufacturers.
• Exploring the Switzerland Mutual Recognition Agreement, Turkey and EFTA agreement with the EU.
• Understanding Common Standards and the Rolling Plan.
• The role of European Union Reference Laboratories in supporting IVDR implementation.

🌟 Course Benefits:

• Save time with a clear, step-by-step understanding of IVDR requirements.
• Gain a profound grasp of regulations in simple terms.
• Prioritize your work effectively to meet the IVDR 2017/746 timelines.
• Discover the reasons behind these regulations and their impact on your business.
• Learn about your specific obligations under the new regulation.
• Understand the EUDAMED system, including registration processes and timelines.
• Get practical examples of UDI carriers creation.
• Learn how to classify IVDDs correctly.
• Navigate the conformity assessment routes for different types of devices.
• Collect sufficient clinical data to ensure compliance.
• Master market surveillance requirements post device launch.
• Post-Brexit insights for both EU and UK manufacturers.
• Understand the roles and responsibilities regarding IVDR in Turkey and EFTA countries.
• Learn how European Union Reference Laboratories can support your compliance efforts.

🎉 Who Should Take This Course? This course is designed for:

• Medical Device Manufacturers (both large companies and startups)
• Quality Assurance and Regulatory Affairs Professionals
• R&D Teams
• Anyone involved in the manufacturing, import, or distribution of IVDDs who wish to ensure compliance with EU regulations.

📅 Enroll Now to Stay Ahead: Stay informed, compliant, and competitive in the fast-paced world of medical devices. Enroll in our "IVDR 2017/746 Regulatory Affairs" course today and secure your position as an industry leader. 🎓✨