The Medical Device Coordination Group (MDCG) has recently released updated guidance for in vitro diagnostic (IVD) manufacturers on the requirements for the In Vitro Diagnostic Regulation’s (IVDR) System and Procedure Pack (SSP). The IVDR, which came into effect in May 2017, aims to ensure the safety and performance of IVD medical devices within the European Union.
The SSP is a key component of the IVDR, as it contains all the necessary information for the proper use of an IVD medical device. It includes instructions for use, information on the intended purpose of the device, and details on how to interpret the results. The SSP is crucial for ensuring that healthcare professionals and patients can use the device safely and effectively.
The updated guidance from the MDCG provides IVD manufacturers with detailed information on what should be included in the SSP, as well as how to ensure compliance with the IVDR. This includes guidance on how to draft clear and concise instructions for use, how to provide information on the intended purpose of the device, and how to ensure that the SSP is easily accessible to users.
In addition, the guidance also provides information on how IVD manufacturers can demonstrate compliance with the IVDR’s requirements for the SSP. This includes guidance on how to conduct risk assessments, how to validate the performance of the device, and how to ensure that the SSP meets the requirements for labeling and packaging.
Overall, the updated guidance from the MDCG is a valuable resource for IVD manufacturers who are looking to ensure compliance with the IVDR’s requirements for the SSP. By following this guidance, manufacturers can ensure that their IVD medical devices are safe and effective for use within the European Union, ultimately benefiting both healthcare professionals and patients.