What Is a Medical Device Modification Under MDR and IVDR?
A medical device modification refers to any change to the design, manufacturing process, software, components, or intended use that may impact compliance with MDR 2017/745 or IVDR 2017/746. Any such modification requires an impact assessment on the current certificate and technical documentation. The change assessment should be overseen by the PRRC, who is responsible for keeping documentation up to date in accordance with Article 15 MDR/IVDR.
Common Situations That Trigger Changes
Typical changes include software updates, changes in component suppliers, modifications to manufacturing technology, or relocating production sites.
- Software or firmware updates
- Supplier or raw material changes
- Production process or site relocation
- Design adjustments to meet new regulatory or market needs
Changes may also stem from EUDAMED registration requirements, UDI-DI updates, or adaptations to the amended MDR under Regulation 2025/1021.
Technical, Organizational, and Systemic Changes
Changes may also involve non-technical elements such as updates to the quality management system documentation, organizational restructuring, or distribution channel modifications. All changes must be assessed for regulatory impact. Changes in economic operators affecting SRN numbers or EUDAMED entries must be reported as formal changes.
How to Distinguish Between Significant and Non-Significant Changes
A change is considered significant if it impacts the design, clinical purpose, function, or safety of the device. Non-significant changes do not require notified body approval but must still be documented and integrated into the quality system. Misclassifying a significant change as non-significant can lead to non-compliance during certification or surveillance audits.
MDCG 2020-3 rev.1 Guidelines
The MDCG 2020-3 rev.1 document defines criteria for classifying changes. Any modification affecting function, design, or intended use is significant. Change assessments should follow the decision flowchart provided in the MDCG annex.
Examples of Significant Changes
Changes that affect safety or performance must be reported to and approved by the notified body prior to implementation.
- Adding a new clinical or diagnostic function
- Relocation of the main production site
- Replacing a critical component supplier
- Changing a control algorithm or user interface
For IVDs, significant changes include modifications to measurement methods or diagnostic parameters that affect performance data.
Examples of Non-Significant Changes
These changes do not affect device safety or performance but must be documented in technical files and the QMS.
- Reformatting instructions without content changes
- Updating product codes without specification changes
- Label edits aligned with UDI that do not impact safety
Change Assessment – Step-by-Step Procedure
Every change must undergo a formal conformity assessment. A key step is analyzing the change’s impact on the MDR/IVDR certificate, particularly in relation to transitional provisions under Article 120 MDR. Per MDCG 2021-25, significant changes may require full conformity reassessment for devices certified under MDD/AIMDD.
Impact Assessment on the Certificate
The manufacturer must determine if the change alters information in the existing certificate. If so, involvement of the notified body is necessary.
Role of the Notified Body
For higher-class devices, significant changes must be approved by the notified body. The manufacturer must submit a change assessment, updated documentation, and justification regarding safety (if applicable).
Required Documentation
Supporting documentation should include:
- Change Assessment Form with justification
- Updated Technical Documentation
- Submission to the notified body (if required)
QMS documents, PMS plans, and PMCF plans must also be updated accordingly.
Common Manufacturer Errors When Implementing Changes
Improper change assessments can result in certificate loss, reassessment requirements, or administrative penalties.
Failure to Report Significant Changes
Some manufacturers unknowingly implement changes without prior assessment, which can invalidate certification and require re-assessment.
Incorrect Change Classification
Failure to use MDCG 2020-3 criteria can lead to incorrect classifications and MDR/IVDR non-compliance.
Discrepancies Between Documentation and Practice
Changes must be reflected in the technical documentation and integrated with the QMS. Data inconsistencies are a major cause of negative audit outcomes.
Updating Technical Documentation and the QMS
All changes—regardless of significance—must be formally recorded in documentation and QMS procedures to maintain continuous MDR/IVDR compliance.
Technical Documentation Updates
Changes must be traceable in the Technical Documentation with clear versioning, date stamps, and scope. For IVDs, updates should also cover the Performance Evaluation Plan and performance data (PER).
Integrating Changes Into the QMS
The ISO 13485-compliant QMS should include a change control procedure addressing risk evaluation, documentation, and internal authorization. Notified body audits verify consistency of implemented changes with the QMS and the Change Log.
MDR/IVDR Compliance After Changes
Changes must not compromise the device’s compliance with MDR or IVDR. Maintaining updated documentation and a coherent QMS is essential for retaining certification validity.
How Pure Clinical Supports Manufacturers in Change Management
Pure Clinical helps manufacturers assess changes under MDR/IVDR and MDCG guidance through:
- change qualification according to MDCG 2020-3 rev.1,
- impact analysis on certificates and technical files,
- preparing forms and communication for the notified body,
- verifying consistency with the QMS and ISO 13485 procedures,
- integrating changes into PMS/PMCF plans and updating EUDAMED and UDI-DI records.
FAQ
Is a change in supplier considered minor if the material specifications remain identical?
Can a manufacturer implement a change before it’s approved by the Notified Body?
What digital tools support change management under ISO 13485 and MDR?