| Regulation / Guidance | Document Section |
|---|---|
| Medical Device Regulation, Annex IX Chapter II Section 4.10 |
All |
| MDCG Guidance Document 2020-03 | All |
Overview:
This record is designed for documenting the evaluation of routine change requests as part of the company’s change management process.
Product Change Evaluation
Note #1: Consider creating separate lists for product and organizational changes to facilitate version-specific documentation. Each product version should ideally have its own list attached to the relevant technical documentation.
Note #2: If any of the questions below are answered with YES, the change must be classified as significant.
Note #3: In this example, “PCR” refers to “Product Change Request” and “OCR” refers to “Organizational Change Request”.
Important Points:
- A YES response in the first two categories (intended use/essential requirements/GSPR) indicates a significant change.
- Changes made to correct a safety-related error or as part of field safety corrective actions must be reviewed with the Notified Body to assess their significance. If no Notified Body was involved in the device’s conformity assessment, such changes are considered significant.
| Evaluation Criteria | |||
|---|---|---|---|
| Change Request ID | #PCR01 | #PCR02 | (…) |
| Description of Change | Performance update to the machine learning algorithm model | Integration of the device with a new clinical IT system | |
| Overall Change Evaluation | Not significant | Significant | |
| Does the change impact the specifications in the Intended Use? (Chart A of MDCG 2020-03, e.g., new user or patient population) | No | No | |
| Does the change affect conformity with the General Safety and Performance Requirements? | No | No | |
| Does the change require additional clinical or usability data to confirm safety and performance? (Chart B of MDCG 2020-03) | No, but internal validation showed improved performance on the same metrics | Yes | |
| Are new risks introduced or do existing risks require updated control measures? (Chart B of MDCG 2020-03) | No | Yes | |
| Does the change alter any built-in control systems or alarms? (Chart B of MDCG 2020-03) | No | No | |
| Does the change modify the operating principle or energy sources? (Chart B of MDCG 2020-03) | No | No | |
| Does the change involve a significant update to the operating system or components? (Chart C of MDCG 2020-03, e.g., major SOUP update) | No | No | |
| Does the change modify the architecture, database structure, or algorithms? (Chart C of MDCG 2020-03, e.g., changes to an algorithm model’s prediction principle) | No, same prediction model | No | |
| Does the change replace manual user input with an automated closed-loop algorithm? (Chart C of MDCG 2020-03) | No | No | |
| Does the change introduce a new diagnostic or therapeutic feature, or a new method of interoperability? (Chart C of MDCG 2020-03) | No | Yes, new method of interoperability | |
| Does the change involve a new user interface or data presentation? (Chart C of MDCG 2020-03) | No | No | |
| Does the change involve modifications by critical suppliers? (Chart D of MDCG 2020-03) | No | No | |
| Does the change affect the way medical data is read or interpreted by users, potentially altering treatment or diagnosis compared to previous versions? | Yes, but with improved diagnostic accuracy | No |
Organizational Change Evaluation
Note: A YES in the first two categories (Intended Use/GSPR) always indicates a significant change.
| Evaluation Criteria | |||
|---|---|---|---|
| Change Request ID | #OCR1 | #OCR2 | (…) |
| Description of Change | Change of company business address | New compliance process for anti-bribery regulations | |
| Overall Change Evaluation | Significant | Not significant | |
| Does the change impact QMS conformity with the General Safety and Performance Requirements (MDR)? | No | No | |
| Does the change affect product conformity with the General Safety and Performance Requirements (MDR) or the approved type/design? | No | No | |
| Does the change involve manufacturing processes, technology, facilities, or equipment that could impact product safety and performance? | No | No | |
| Does the change impact the company’s location of operations? | Yes | No | |
| Does the change involve modifications by critical suppliers? (Chart D of MDCG 2020-03) | No | No | |
| Does the change affect arrangements to maintain QMS compliance with relevant harmonized standards/MDR (e.g., design verification, validation)? | No | No |
Examples of non-significant changes, based on the guidance documents, include:
- Software updates adding non-therapeutic features like printing, improved image quality, or additional language options.
- UI modifications with minimal impact on patient treatment or diagnosis.
- Fixing logic errors that don’t pose safety risks and keep the system within specifications.
- Design adjustments that maintain tolerances without introducing new features.
- Labeling changes to add languages for different regulatory requirements.
- Minor clarifications of warning or precaution wording, unless a contraindication is added or removed, which requires Notified Body involvement.
Examples of significant changes include:
- Algorithm adjustments that impact diagnosis or treatment.
- The introduction or removal of an alarm function affecting patient treatment responses.
- Presentation of medical data in a new format, dimension, or unit.