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 aims to provide clarity and support for manufacturers navigating the complex process of submitting their products for regulatory approval under the new IVDR.
The IVDR, which came into effect in May 2017, represents a significant overhaul of the regulatory framework for in vitro diagnostic devices in the European Union. One of the key changes introduced by the IVDR is the requirement for manufacturers to submit their products through the SSP, a centralized online platform designed to streamline the submission process and improve transparency and efficiency.
The updated guidance from the MDCG provides detailed instructions on how to use the SSP, including information on how to create an account, submit applications, and track the progress of submissions. It also outlines the documentation and information that manufacturers need to provide when submitting their products for approval, such as technical documentation, clinical data, and labeling information.
In addition, the guidance clarifies the roles and responsibilities of different stakeholders involved in the submission process, including notified bodies, competent authorities, and the European Commission. It also provides information on how to address any issues or challenges that may arise during the submission process, such as technical difficulties or requests for additional information.
Overall, the updated guidance on the IVDR’s SSP is a valuable resource for IVD manufacturers looking to navigate the regulatory landscape in the EU. By following the guidance provided by the MDCG, manufacturers can ensure that their products meet the necessary requirements for approval and can be successfully brought to market in compliance with the IVDR.