IEC 62304 is finally getting a much-needed update! The goal? To keep up with the fast-moving world of software, AI, and evolving regulatory frameworks and make it more relevant and better aligned with other industry guidelines.
Proposed Key Changes:
The updated standard will apply to:
- Software that’s part of a medical device
- Software embedded in specific health hardware
- Software as a Medical Device (SaMD)
- Software-only products designed for health management, maintenance, or care delivery
- Health software using AI or machine learning (ML)
New Software Process Rigor Levels:
Proposed to change from current software safety classification to using Software Process Rigor levels:
| Safety Classification | Rigor Level |
| Class A | Low |
| Class B & C | High |
Other Notable Updates
- Changes to Software Development Process
- Changes include updates to the plan, Software Requirements Analysis, and Software Architecture Design
- Changes to Risk Management
- In line with the introduction of Software Process Rigor Levels.
- The two-level classification has been proposed to simplify the software classification process. Also simplifying whether the software contributes to a hazardous situation according to the risk management process for the product.
- Maintenance Updates
- Updates to the of definitions for software maintenance.
- Updates to General requirements
- Example: Removal of the Quality System general requirements. IEC 62304 is not a product level standard, so these aspects should remain in the manufacturers’ quality system applied to their products.
- Modifications for Legacy Software
- This element is to be moved to an informative annex.For Legacy IEC 62304 software, updating and reviewing the software development plan to assess the impact of the change.
Why This Matters?
If you work in digital health, it’s worth reviewing your processes to make sure they align with the new IEC 62304 updates when they come into effect. These changes could potentially impact:
Bottom line: staying ahead of these updates will help with compliance and keep you on track in an ever-evolving regulatory landscape.
Key Dates to consider
Public commentary has now ended with comment resolution start date from 20th March 2026 and proposed changes from these commentaries to be made where applicable.
Approval start date: 22 May 2026
Publication start date: 12 August 2026
Source: British Standards Institution – Project
