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Medical Device Change Control Request Template

Changes to a medical device or its process must be identified, reviewed, verified, approved and documented before implementation. This request form captures the change and the questions that reviewers must answer.

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Medical Device Change Control Request Template

Change Control Request

Company: Acme Medical Devices Inc. Request No: ECR-2026-118 Date: 2026-10-20 Requestor: J. Alvarez, Manufacturing Engineering Change type: Design

Change Description

Affected items: Part 200-014 housing, drawing rev C to D

Change housing wall thickness from 1.6 mm to 1.8 mm to reduce cracking during sterilization cycles.

Reason: Three complaints and one CAPA (CAPA-0231) for housing cracks after EO sterilization.

Impact Assessment

Regulatory impact: To be determined Risk management file: Review hazard H-07 (structural failure); update risk management file if controls change. Verification or validation: Repeat drop test DVP-0042 and re-run EO sterilization compatibility on 3 lots. Existing stock: Use up

Impact Checklist

AreaAffected (Y/N)OwnerAction
Design history file
Labeling and IFU
Process validation
Supplier quality agreement
Training

Approvals

Requestor / Date
Engineering / Date
Quality assurance / Date
Regulatory affairs / Date
Operations / Date

Starting point, not legal or regulatory advice. Determining whether a change needs a new submission depends on your market and device class, so follow your procedure and regulatory guidance.

Connect change requests to ERP ECOs?

Optional review of linking quality change records to ERP engineering changes.

Optional. The tool and every export work without this. No spam.

How to use the form

Describe the change and its reason in plain terms, and reference the complaint or CAPA that triggered it if one exists. The impact assessment is the core of the form: ask whether regulatory status, the risk file, verification and validation, labeling, suppliers and training are affected. Send it to each function for sign-off, then export to PDF or Word. Implementation should only start after approval.

Regulatory background

ISO 13485 clause 7.3.9 requires design changes to be identified, reviewed, verified, validated as appropriate, and approved before implementation, including evaluation of the effect on constituent parts and product already delivered. Under 21 CFR 820.30(i) in the US, and equally for production and process changes, the evaluation must consider whether a new submission or notification is needed.

  • Assess regulatory impact before approval
  • Update the risk file where hazards or controls change
  • Decide disposition of stock and WIP
  • Record the effectivity date or lot

Common mistakes

Treating small changes as exempt is the common failure, such as a new supplier for a molded part or a cleaner switch, which can change biocompatibility or validated cleaning. Others forget to include labeling and training. Decide against documented criteria whether a change is minor, and keep the rationale on record.

Frequently Asked Questions

Is every change a design change?

No. Process, supplier, labeling, software and document changes also need control. Your procedure should define categories and the approvals each category needs.

When is a new 510(k) needed?

It depends on whether the change could significantly affect safety or effectiveness, or is a major change to intended use. FDA publishes guidance on assessing modifications. Document your assessment either way.

Who must approve?

At minimum engineering, quality and regulatory, plus operations where manufacturing changes. Set the list in your procedure.

What about emergency changes?

Define an expedited route with after-the-fact documentation and the same assessment, never a bypass without records.

If change requests live in email and ERP engineering change orders separately, Netray can help connect them. Ask for a short review.

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