T-023-001 Change control

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Part I - Change initiation

Change identification

Field	Value
Change Control ID	CCR-YYYY-XXX
Change name
Date of initiation
Originator
Originator department

Change description

Provide a detailed description of the proposed change.

Source of change

Select the source that triggered this change request:

• Risk mitigation (GP-013 Risk Management)
• Non-conformity report (GP-006 Non-conformity)
• CAPA (GP-006 CAPA)
• Internal audit (GP-003 Internal audit)
• Regulatory change
• Customer feedback (GP-014 Feedback and complaints)
• Other: **____**

Type of change

• Product change (design, labelling, software, etc.)
• Process/QMS change (procedures, work instructions, etc.)

Product phase (if applicable)

Select the applicable phase for product changes:

• Design Freeze Phase (Pre-market) - Submission for approval ongoing
• Design Freeze Phase (Post-market) - CE certificate obtained, product in market
• Design History Phase (Post-market) - CE certificate obtained, product in market
• N/A - This is a QMS/Process change only

Affected products/documents

Product/Document	Version	Description

Part I approval

Role	Name	Signature	Date
Originator
JD-003
JD-004

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Part II - Impact analysis and classification

Impact analysis checklist

Evaluate the impact of the proposed change on the following aspects:

Aspect	Impact (Yes/No)	Description of impact
Function
Performance
Usability
Safety
Software version
Existing devices in market
Risk management
Labelling
Regulatory requirements
Product/software classification
Quality management system
Cybersecurity
Medical devices/systems interfaces

Risk analysis impact

Evaluate whether the change introduces new risks or modifies existing risks. Reference the risk management file if applicable.

QMS documentation impact

List all QMS documents impacted by this change:

Document ID	Document name	Type of change needed

Regulatory classification

Is this change substantial/significant?

For EU market (MDR 2017/745):

Apply criteria from NBOG 2014-3

• SUBSTANTIAL - Requires immediate BSI notification before implementation
• NON-SUBSTANTIAL - BSI reviews at next annual surveillance audit

For US market (FDA):

Apply criteria from FDA Guidance - Deciding When to Submit a 510(k)

• SIGNIFICANT - Requires new 510(k)/De Novo submission
• NON-SIGNIFICANT - No FDA notification required
• PCCP applicable - Change covered by approved Predetermined Change Control Plan (GP-024)

Classification justification

Provide detailed rationale for the classification decision:

Part II review

Role	Name	Signature	Date
JD-005
JD-003
JD-001

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Part III - Regulatory notifications (if applicable)

BSI notification (EU - Substantial changes only)

warning

For substantial changes, do NOT implement until BSI has validated the action plan.

Field	Value
BSI notification date
BSI reference number
BSI response date
BSI approval status	[ ] Approved / [ ] Rejected / [ ] Pending

FDA notification (US - Significant changes only)

Field	Value
Submission type	[ ] 510(k) / [ ] De Novo / [ ] PCCP
Submission date
Submission number
FDA decision date
FDA decision	[ ] Cleared / [ ] Denied / [ ] Pending

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Part IV - Action plan

Planned activities

#	Activity description	Responsible	Target date	Status
1				[ ] Pending / [ ] In progress / [ ] Completed
2				[ ] Pending / [ ] In progress / [ ] Completed
3				[ ] Pending / [ ] In progress / [ ] Completed
4				[ ] Pending / [ ] In progress / [ ] Completed
5				[ ] Pending / [ ] In progress / [ ] Completed

Resources required

Identify any special resources, tools, or training required:

Risk mitigation during implementation

Describe any measures to mitigate risks during the implementation phase:

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Part V - Implementation

Implementation details

Field	Value
Implementation start date
Implementation completion date
Implemented by

Verification activities

Describe verification activities performed to confirm the change was implemented correctly:

Verification activity	Result	Evidence reference

Documents updated

Document ID	Document name	New version	Update date

DHF/DMR update confirmation

• Design History File (DHF) updated
• Device Master Record (DMR) updated
• Technical file updated (EU)
• Device Master File (DMF) updated (US)

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Part VI - Verification of effectiveness

Effectiveness monitoring

Field	Value
Monitoring period	3-6 months or as needed
Monitoring start date
Monitoring end date
Responsible

Effectiveness evaluation

Describe how the effectiveness of the change was evaluated:

Results and conclusions

• Change objectives achieved
• Change objectives partially achieved - Additional actions required
• Change objectives not achieved - Corrective actions required

Comments:

Additional actions (if applicable)

Action	Responsible	Target date

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Part VII - Closure

Final approval

Role	Name	Signature	Date
JD-004
JD-005
JD-001

Archival

• Change Control form archived in DHF/DMR
• All related evidence archived
• Traceability verified

Field	Value
Archive location
Archive date

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Record signature meaning

• Author: JD-004
• Review: JD-005
• Approval: JD-001 or JD-003

Template signature meaning

info

Delete this section when you create a new record from this template.

• Author: JD-004
• Review: JD-005
• Approval: JD-001