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 IVDR, which came into effect in May 2017, aims to ensure the safety and performance of IVD medical devices in the European Union.
The new guidance provides detailed information on the requirements that IVD manufacturers must meet in order to comply with the IVDR. It covers a wide range of topics, including classification of IVD devices, conformity assessment procedures, clinical evidence requirements, post-market surveillance, and labeling and instructions for use.
One of the key changes introduced by the IVDR is the classification of IVD devices based on risk. Under the new regulation, IVD devices are classified into four risk classes (A, B, C, and D), with Class D devices being the highest risk category. Manufacturers must ensure that their devices are classified correctly in order to comply with the IVDR.
The guidance also outlines the conformity assessment procedures that IVD manufacturers must follow in order to demonstrate compliance with the IVDR. This includes requirements for technical documentation, quality management systems, and post-market surveillance activities.
In addition, the guidance provides detailed information on the clinical evidence requirements for IVD devices. Manufacturers must provide clinical data to demonstrate the safety and performance of their devices, including data from clinical studies and performance evaluations.
Post-market surveillance is another important aspect of IVDR compliance. Manufacturers must have systems in place to monitor the performance of their devices once they are on the market, and to report any adverse events or safety issues to the relevant authorities.
Finally, the guidance covers requirements for labeling and instructions for use of IVD devices. Manufacturers must ensure that their devices are properly labeled with essential information such as intended use, performance characteristics, and precautions for use.
Overall, the updated guidance from MDCG provides valuable information for IVD manufacturers on how to comply with the IVDR. By following these guidelines, manufacturers can ensure that their devices meet the necessary safety and performance standards, and can continue to market their products in the European Union.