Assess implemented changes determining regulatory significance and required compliance actions.
Evaluation Criteria | Impact | Details |
---|---|---|
Does the change impact the intended use, patient population, intended users, use environment, contraindications, or interaction with the body? | Impacted | Intended use expanded to include HRV monitoring for cardiac patients. Patient population remains the same but now includes additional monitoring capability. |
Does the change impact the device’s conformity with the general safety and performance requirements? | Not Impacted | Device continues to meet all GSPR requirements. HRV functionality enhances monitoring capabilities without compromising existing safety features. |
Does the change introduce new risks that require control measures or is the existing risk profile for the device negatively affected by the new risks? | Impacted | New risk identified: R-087 - Incorrect HRV calculation could lead to misinterpretation of cardiac status. Risk controls implemented through algorithm validation and user training materials. |
Does the change have an impact on clinical performance or safety which necessitates additional clinical or usability testing? | Impacted | Usability testing performed to validate new HRV interface elements. Clinical literature review conducted to support HRV parameter selection and normal ranges. |
Does the change alter built-in control mechanisms or alarms, core operating principles, operating systems or sources of energy or introduce a new channel of interoperability? | Not Impacted | No changes to existing alarms or control mechanisms. HRV analysis operates as additional monitoring feature without affecting core heart rate monitoring functions. |
Does the change introduce a new or change to the algorithm used for the core medical functionality? | Impacted | New HRV analysis algorithms added for medical functionality. Algorithms validated against established clinical standards and tested with diverse patient data sets. |
What is the process for preparing a new software release?
How do I determine if a change is significant?
What verification is required for change evaluation?
When do I need to notify my notified body about changes?
How should I handle cumulative changes over time?
What documentation should be updated after change evaluation?