The Medical Device Coordination Group (MDCG) has recently released updated guidance for in vitro diagnostic (IVD) manufacturers on compliance with the In Vitro Diagnostic Regulation (IVDR). The revised guidance, known as the Summary of Safety and Performance (SSP) guidance, aims to provide clarity and direction for manufacturers as they navigate the complex regulatory landscape of the IVDR.
The IVDR, which came into effect in May 2017, represents a significant overhaul of the regulatory framework for IVDs in the European Union. The regulation introduces stricter requirements for the performance and safety of IVDs, as well as increased scrutiny of manufacturers’ technical documentation and post-market surveillance activities.
One of the key changes introduced by the IVDR is the requirement for manufacturers to prepare and maintain a Summary of Safety and Performance (SSP) for each IVD product placed on the market. The SSP is a crucial document that provides essential information on the intended purpose, performance characteristics, and safety profile of the IVD, as well as details on any clinical data or studies supporting its performance.
The revised SSP guidance released by the MDCG provides detailed instructions on how manufacturers should prepare and maintain their SSPs in compliance with the IVDR. The guidance covers a wide range of topics, including the format and content requirements for SSPs, the documentation and verification of performance claims, and the inclusion of clinical data and post-market surveillance information.
In addition to providing guidance on the preparation of SSPs, the MDCG guidance also offers valuable insights into how manufacturers can ensure ongoing compliance with the IVDR. This includes recommendations on how to update SSPs in response to changes in the performance or safety profile of an IVD, as well as guidance on how to manage post-market surveillance activities and report any adverse events or incidents.
Overall, the release of the revised SSP guidance by the MDCG represents a significant milestone in the implementation of the IVDR. By providing clear and comprehensive guidance on compliance with the SSP requirements, the MDCG is helping to support IVD manufacturers in their efforts to navigate the regulatory landscape and ensure the safety and performance of their products.
In conclusion, IVD manufacturers should carefully review the updated SSP guidance released by the MDCG and take steps to ensure that their SSPs are prepared and maintained in compliance with the IVDR. By following the guidance provided by the MDCG, manufacturers can demonstrate their commitment to regulatory compliance and ensure the safety and performance of their IVD products for patients across the European Union.