The Medical Device Coordination Group (MDCG) has recently released updated guidance on the In Vitro Diagnostic Regulation’s (IVDR) Single Submission Portal (SSP) for IVD manufacturers. This guidance is crucial for manufacturers to stay compliant with the new regulations and ensure a smooth transition to the IVDR.
The IVDR, which came into effect in May 2017, aims to improve the safety and performance of in vitro diagnostic devices in the European Union. One of the key requirements of the IVDR is the use of the SSP for submitting applications for market authorization, conformity assessment, and post-market surveillance.
The SSP is a centralized online platform that allows manufacturers to submit all necessary documentation and information related to their IVD devices in a single submission. This streamlines the regulatory process and makes it easier for manufacturers to comply with the requirements of the IVDR.
The updated guidance from the MDCG provides detailed instructions on how to use the SSP effectively and ensure that all necessary information is included in the submission. It also outlines the different types of submissions that can be made through the portal, such as applications for new devices, changes to existing devices, and notifications of incidents or recalls.
One of the key changes in the updated guidance is the requirement for manufacturers to provide more detailed information on the performance and safety of their IVD devices. This includes data on clinical performance, analytical performance, and risk management, as well as information on the intended use and target population of the device.
Manufacturers are also advised to ensure that all documentation submitted through the SSP is accurate, up-to-date, and compliant with the requirements of the IVDR. Failure to do so could result in delays in the approval process or even rejection of the application.
Overall, the updated guidance on the SSP from the MDCG is a valuable resource for IVD manufacturers looking to stay compliant with the IVDR. By following the instructions provided in the guidance, manufacturers can ensure that their submissions are complete and accurate, and that they are able to navigate the regulatory process smoothly.
In conclusion, staying compliant with the IVDR is essential for IVD manufacturers operating in the European Union. The updated guidance on the SSP from the MDCG provides valuable information on how to use the portal effectively and ensure that all necessary information is included in submissions. By following this guidance, manufacturers can streamline the regulatory process and ensure that their IVD devices meet the safety and performance requirements of the IVDR.