BIVDA have collaborated with BSI to develop a comprehensive list of relevant standards that relate to various aspects of IVD product development and manufacturing. We have worked jointly with BSI to compile this list of IVD Standards to help BIVDA members identify those standards relevant to IVD products and organisational needs.
While the list aims to provide a clear and concise overview of the existing standards, it may not be all inclusive of the standards required for a specific device. The determination of applicable standards is always the responsibility of the manufacturer.
Once logged into BIVDA account, members can find this list of IVD Standards here. These standards serve as a guide for manufacturers to adhere to the best practices to build safe and effective IVD medical devices.
To find out more information about BSI and individual BSI standards, please visit their website.
If you wish to discuss this in more detail, please contact Regulatory@bivda.org.uk