Regulation (EU) 2017/746

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Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU is a significant regulatory framework that governs the approval, manufacture, and distribution of in vitro diagnostic (IVD) medical devices within the European Union (EU). This regulation is part of a broader effort by the EU to ensure a high level of health and safety protection for its citizens while supporting the smooth functioning of the internal market.

Overview

Regulation (EU) 2017/746, often referred to as the IVDR, introduces a number of key changes and enhancements to the regulatory landscape for in vitro diagnostic medical devices. It aims to increase the safety and reliability of IVDs through more stringent pre-market requirements and enhanced post-market surveillance. The regulation applies to all manufacturers, authorized representatives, importers, and distributors of IVDs within the EU.

Key Provisions

The IVDR introduces several important provisions that significantly impact the IVD industry:

• Classification System: The regulation implements a new risk-based classification system for IVDs, dividing them into four classes (A, B, C, and D) based on their intended purpose and inherent risks. This system aligns more closely with international guidelines and ensures that higher-risk devices undergo more rigorous assessment.

• Notified Bodies: Under the IVDR, the involvement of Notified Bodies is expanded. These organizations are responsible for assessing the conformity of certain classes of IVDs before they can be marketed in the EU. The regulation also imposes stricter requirements for the designation and monitoring of Notified Bodies.

• Clinical Evidence: The IVDR requires manufacturers to provide more comprehensive clinical evidence to demonstrate the safety and performance of their devices. This includes the need for clinical performance studies and post-market clinical follow-up.

• EUDAMED: The European Database on Medical Devices (EUDAMED) is significantly expanded under the IVDR. It serves as a comprehensive database for the registration of devices, relevant economic operators, and certificates, enhancing transparency and traceability.

• Post-Market Surveillance: The regulation mandates a more systematic and proactive approach to post-market surveillance, requiring manufacturers to continuously monitor the performance and safety of their devices throughout their lifecycle.

• Unique Device Identification (UDI) System: The IVDR introduces a UDI system to improve the traceability of IVDs. This system requires devices to be marked with a unique identifier, facilitating better monitoring and recall of devices if necessary.

Impact

The implementation of Regulation (EU) 2017/746 represents a significant shift in the regulatory requirements for in vitro diagnostic medical devices in the EU. Manufacturers face increased obligations regarding the demonstration of safety and performance, which may impact the time and cost associated with bringing new devices to market. However, these changes are expected to enhance patient safety and the overall quality of IVDs available in the EU.

Compliance Timeline

The IVDR was officially published on 5 May 2017 and entered into force on 25 May 2017. However, it provided a transitional period for manufacturers and other stakeholders to achieve full compliance. The full application of the regulation was initially set for 26 May 2022, allowing for a gradual adaptation to the new requirements.

Conclusion

Regulation (EU) 2017/746 marks a pivotal development in the regulatory oversight of in vitro diagnostic medical devices in the European Union. By introducing more stringent requirements and a robust framework for oversight, the regulation aims to ensure the highest standards of safety and performance for IVDs, ultimately benefiting patients and healthcare systems across the EU.