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When medical devices and software products are created, all parties involved must have a firm understanding of compliance regulations, conformity marking and classification types, to ensure that the development process aligns with the highest standards of safety, efficacy, and quality. 

Unfortunately, recent and proposed changes to these regulations following the UK’s exit from the EU, make it increasingly difficult to source the most relevant and reliable information. Some documents have undergone changes and adaptations, while others refer to existing literature.

To help guide you through the process, we’re sharing some of the most up-to-date resources so that you know how