Understanding the GSPR under IVDR

The In Vitro Diagnostic Regulation (IVDR) Regulation (EU) 2017/746 has made a significant impact on the way in vitro diagnostic devices are regulated in the European Union. A crucial element of this regulation is the General Safety and Performance Requirements (GSPR), which every IVD device must meet to achieve compliance. In this article, we’ll explore what the GSPR is and why it matters to manufacturers of IVD devices.

Understanding the GSPR
The GSPR represents a set of legally enforceable requirements that apply to all IVD medical devices sold within the EU. The requirements cover different areas, including the safety and performance characteristics of the IVD device, technical documentation, labelling, and the responsibilities of manufacturers.

Why the GSPR Matters
The GSPR is crucial for several reasons. Firstly, they establish a uniform set of rules across the EU, ensuring that all IVD devices meet the same high standards. Secondly, compliance with the GSPR is essential for obtaining CE marking, which indicates that a product conforms with EU legislation and allows free movement within the European market.

Navigating the GSPR under IVDR
The IVDR outlines 20 different chapters of  GSPRs that manufacturers must consider during the design, production, and post-production processes of IVD devices. These chapters cover a range of aspects, such as risk management, performance characteristics, design and manufacturing information, product verification and validation, and more.

Notably, the GSPR under IVDR places a greater emphasis on clinical evidence than its predecessor, the In Vitro Diagnostic Directive (IVDD). The new regulations require manufacturers to demonstrate a more comprehensive level of clinical evidence to support the safety and performance claims of their devices.

Final Thoughts
Compliance with the GSPR under IVDR is not just about meeting regulatory requirements; it’s about ensuring that IVD devices are safe and effective for their intended use. As we transition from IVDD to IVDR, it’s crucial for manufacturers to familiarize themselves with these new requirements and adjust their processes accordingly.

Navigating the complexities of the GSPR and IVDR can be challenging, but with a solid understanding and careful planning, manufacturers can ensure they meet these standards and continue to deliver safe, effective IVD devices to the market.

If you’re finding the IVDR tough to navigate, don’t worry – QRcompliance is here to help. Visit our website at www.qrcompliance.nl. We also provide a selection of templates in our online shop to assist you in setting up compliant documentation seamlessly. Let QRcompliance guide you through the intricacies of the IVDR.

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