The Essential Requirements of the Directives are replaced by General Safety and Performance Requirements in the Regulations. Although many of the old requirements have been retained there are also many changes.
There are more requirements than before and they tend to be more detailed.
Some of the changes are subtle, but some of them expand the requirements into entirely new areas such as nanomaterials, cybersecurity, human origin materials and safe disposal of devices.
Manufacturers should carry out a gap analysis between the new requirements and existing compliance as soon as possible and assess the cost implications.