The Medical Device Coordination Group (MDCG) has recently released updated guidance on the In Vitro Diagnostic Regulation’s (IVDR) Single Submission Portal (SSP) to assist in vitro diagnostic (IVD) manufacturers in complying with the new regulations. The IVDR, which came into effect in May 2017, aims to ensure the safety and performance of IVD medical devices while also improving transparency and traceability throughout the supply chain.
The SSP is a key component of the IVDR, as it serves as a centralized platform for IVD manufacturers to submit their technical documentation and other relevant information to the competent authorities for market authorization. The updated guidance from the MDCG provides detailed instructions on how to use the SSP effectively, including information on how to create an account, submit applications, and track the status of submissions.
One of the main changes introduced in the updated guidance is the requirement for IVD manufacturers to provide more detailed information on the performance evaluation of their devices. This includes data on clinical performance, analytical performance, and scientific validity, as well as information on the intended purpose of the device and its target population. By providing this additional information, manufacturers can demonstrate that their devices meet the requirements of the IVDR and are safe and effective for use.
The updated guidance also includes information on how to address any deficiencies or issues that may arise during the submission process. This includes guidance on how to respond to requests for additional information from the competent authorities, as well as how to update submissions with new data or information as needed. By following these guidelines, IVD manufacturers can ensure that their submissions are complete and accurate, reducing the risk of delays or rejections.
Overall, the updated guidance on the IVDR’s Single Submission Portal is a valuable resource for IVD manufacturers looking to comply with the new regulations. By following the instructions provided by the MDCG, manufacturers can navigate the submission process more effectively and ensure that their devices meet the necessary requirements for market authorization. This will ultimately help to improve patient safety and ensure that IVD devices on the market are safe and effective for use.