The first major change is the product scope covered by this new version. In the will of alignment of IEC 82304-1 and IEC 62304, the latter has now an extended product scope with better coverage of the former: Health Software. To be sure that the reader understands that both are aligned, the diagram found in IEC 82304 Annex A has been copied into IEC 62304 Clause 1 “Scope”. We can anticipate that the next version of IEC 82304-1 will see the diagram in annex A be moved to Clause 1 accordingly.
Yet, the big difference between IEC 62304 and IEC 82304-1 remains: IEC 62304 covers embedded software, not IEC 82304-1 (replaced by IEC 60601-1 for embedded software)