The General Safety and Performance Requirements (GSPR) outlined in Annex I of both the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are crucial elements that every manufacturer should pay close attention to. They provide specific guidelines and expectations for ensuring the safety and performance of in vitro diagnostic devices. In this blog post, we will explore the importance of GSPR and why they should be a focal point for manufacturers.
Stop looking at the GSPR like it's some dreary and bulky table that you need to fill. Instead, understand the GSPR as a roadmap towards your device's compliance with the MDR/IVDR! By embracing and adhering to the GSPR, manufacturers can confidently navigate the regulatory landscape, ensuring the safety and effectiveness of their products.
GSPR also serve as a valuable way for exposing uncertainties. If there are any doubts or questions about whether a specific requirement applies to a particular device, manufacturers should seek guidance from experts or their notified body - the earlier the better. Seeking clarification early on can help eliminate uncertainties and prevent costly delays in the certification process.
To demonstrate compliance with GSPR, manufacturers should utilize existing standards and common specifications. These resources provide guidance and benchmarks for meeting the requirements effectively. By identifying and applying relevant standards, manufacturers can streamline their compliance efforts and ensure consistent quality across their product portfolio.
While standards exist for many GSPR, there may be instances where specific requirements lack established standards. In such cases, manufacturers should dedicate sufficient time to carefully consider and develop appropriate solutions. This could involve conducting additional testing, gathering scientific evidence, or consulting experts to meet the requirements effectively.
After implementing measures to fulfill GSPR, it is essential to revisit and document the compliance actions taken. This step demonstrates a manufacturer's commitment to meeting regulatory requirements and ensuring ongoing compliance. Regularly reviewing and updating documentation helps maintain a high level of quality and ensures that the device continues to meet the necessary safety and performance standards.
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