The Medical Device Coordination Group (MDCG) has recently released updated guidance on the Specific Requirements for Single-Use Products (SSP) for in vitro diagnostic (IVD) manufacturers. This new guidance aims to align with the In Vitro Diagnostic Regulation (IVDR) and provide clarity on the requirements for manufacturers producing single-use IVD devices.
The IVDR, which came into effect in May 2017, introduced stricter regulations for IVD devices to ensure their safety and effectiveness. As part of these regulations, manufacturers of single-use IVD devices are required to meet specific requirements outlined in the IVDR.
The updated guidance from MDCG provides detailed information on the requirements for SSP under the IVDR, including definitions, labeling requirements, and conformity assessment procedures. It also outlines the responsibilities of manufacturers in ensuring the safety and performance of their single-use IVD devices.
One key aspect of the updated guidance is the emphasis on risk management for SSP. Manufacturers are required to conduct a risk assessment to identify and mitigate potential risks associated with their single-use IVD devices. This includes assessing the potential harm to patients, users, and other stakeholders, as well as identifying any potential hazards or failure modes.
In addition, the guidance provides information on the labeling requirements for SSP under the IVDR. Manufacturers are required to provide clear and accurate information on the intended use of their single-use IVD devices, as well as any warnings or precautions that need to be taken into account when using the device.
Furthermore, the guidance outlines the conformity assessment procedures that manufacturers must follow to ensure that their single-use IVD devices meet the requirements of the IVDR. This includes conducting performance evaluations, clinical evaluations, and post-market surveillance activities to demonstrate the safety and effectiveness of their devices.
Overall, the updated guidance on SSP for IVD manufacturers released by MDCG is a valuable resource for manufacturers looking to ensure compliance with the IVDR. By following the guidance provided, manufacturers can ensure that their single-use IVD devices meet the necessary requirements for safety and effectiveness, ultimately benefiting patients and healthcare providers alike.