The Medical Device Coordination Group (MDCG) has recently released updated guidance on the In Vitro Diagnostic Regulation’s (IVDR) Single Registration Number (SRN) and Single Submission Portal (SSP) to assist in vitro diagnostic (IVD) manufacturers in compliance 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 harmonizing regulations across the European Union. One of the key requirements of the IVDR is the implementation of a Single Registration Number (SRN) and Single Submission Portal (SSP) for IVD manufacturers.
The SRN is a unique identifier assigned to each manufacturer, importer, or authorized representative of IVD medical devices. It is used to track and monitor devices throughout their lifecycle, from manufacturing to post-market surveillance. The SSP is an online platform where manufacturers can submit their applications for conformity assessment and market authorization.
The updated guidance released by the MDCG provides detailed information on how to obtain an SRN, register on the SSP, and submit applications for conformity assessment and market authorization. It also includes instructions on how to update and maintain information on the SRN and SSP, as well as how to handle changes in ownership or legal status.
The guidance emphasizes the importance of accurate and up-to-date information on the SRN and SSP to ensure compliance with the IVDR. It also highlights the need for manufacturers to familiarize themselves with the requirements of the IVDR and seek assistance from competent authorities or notified bodies if needed.
Overall, the updated guidance on the IVDR’s SRN and SSP released by the MDCG is a valuable resource for IVD manufacturers looking to navigate the complex regulatory landscape of the European Union. By following the guidance provided, manufacturers can ensure that their devices meet the necessary safety and performance standards while also maintaining compliance with the IVDR.