Batch certification

Batch certification is the process of assessing the compliance of a specific batch of products. It is useful for repeated imports of products. Based on the assessment results, a certificate for single importation of medical devices is issued by the conformity assessment body.

Batch certification can be conducted according to various standards required in specific industries, including for medical devices.

Batch certification ensures the quality and safety of products from a particular batch and includes testing to provide consumers with confidence that the products meet the required standards and regulations.

The certificate for a batch is issued by the conformity assessment body based on the evaluation of technical documentation and conducted tests. It is not commonly performed in Ukraine, as not all laboratories of conformity assessment bodies can conduct the necessary tests.