With access to the technical documentation, a manufacturer needs to show equivalence in regard to technical, biological, and clinical characteristics and properties. With this, no significant difference in the safety and clinical performance, summarized in the general safety and performance requirements (GSPR), should be detected to claim equivalence.
Another often made mistake is to claim equivalence to more than one medical device. This, in fact, is not possible as equivalence can only be claimed to a single product.