New IEC 62304 Revision Proposal: What Changes for Healthcare Software?

The new proposal to revise IEC 62304 introduces significant changes for the development of software for medical devices and healthcare software. Still in the analysis phase, this proposal aims to expand the draft standard to include Health Softwarei.e. software used in the healthcare sector, even if it is not classified as a medical device. The aim is to align the regulation with the emerging needs of the sector, ensuring greater clarity and applicability for manufacturers and developers.

The proposed changes include simplifying the classification of software rigor, replacing the current A, B and C categories with just two levels (Level I and Level II). In addition, the proposal provides for the removal of specific Quality System requirements, leaving the management of these aspects to the manufacturers, within their own systems. Another important change relates to Risk Management, which no longer explicitly requires compliance with ISO 14971, although this remains a relevant reference for medical device software.

The approach to legacy software will also be adjusted, with its guidelines transferred to an informative annex, allowing greater flexibility for manufacturers dealing with previous versions of the software. As far as the maintenance process is concerned, the proposal makes it clear that any addition of new features must follow the normal development cycle, ensuring traceability and transparency.

It is important to note that these changes are still at the proposal stage and do not constitute the official version of the standard. However, manufacturers should follow this revision closely to prepare for possible future adaptations.

For more details, see the full PDF document below.