# Medical Device Change Control Request Template > Source: https://netray.co/tools/medical-device-change-control-request-template > Publisher: Netray (netray.co), AI and integration engineering for ERP and manufacturing systems. > Section: Free Tools ## Short answer Change request form with impact assessment on regulatory filings, risk files, validations and labeling. ## Category engineering-plm ## Industry Medical Devices ## Audience - Quality engineer - Regulatory affairs - Design engineer ## Tool **Kind:** template **Output:** document **Fields:** #### Company name **Key:** company **Type:** text **Default:** Acme Medical Devices Inc. #### Change request number **Key:** ecn_no **Type:** text **Default:** ECR-2026-118 #### Date requested **Key:** date **Type:** date **Default:** 2026-10-20 #### Requestor **Key:** requestor **Type:** text **Default:** J. Alvarez, Manufacturing Engineering #### Affected items **Key:** affected **Type:** text **Default:** Part 200-014 housing, drawing rev C to D #### Change type **Key:** change_type **Type:** select **Options:** - Design - Process - Supplier - Labeling - Software - Document only **Default:** Design #### Description of change **Key:** description **Type:** textarea **Default:** Change housing wall thickness from 1.6 mm to 1.8 mm to reduce cracking during sterilization cycles. #### Reason for change **Key:** reason **Type:** textarea **Default:** Three complaints and one CAPA (CAPA-0231) for housing cracks after EO sterilization. #### Regulatory impact **Key:** reg_impact **Type:** select **Options:** - None - Letter to file - New 510(k) assessment - PMA supplement assessment - Notified body notification - To be determined **Default:** To be determined #### Risk file impact **Key:** risk_impact **Type:** text **Default:** Review hazard H-07 (structural failure); update risk management file if controls change. #### Verification or validation required **Key:** validation **Type:** textarea **Default:** Repeat drop test DVP-0042 and re-run EO sterilization compatibility on 3 lots. #### Existing stock disposition **Key:** disposition **Type:** select **Options:** - Use up - Rework - Scrap - Not applicable **Default:** Use up **Blocks:** #### Change Control Request **Body:** Company: {{company}} Request No: {{ecn_no}} Date: {{date}} Requestor: {{requestor}} Change type: {{change_type}} #### Change Description **Body:** Affected items: {{affected}} {{description}} Reason: {{reason}} #### Impact Assessment **Body:** Regulatory impact: {{reg_impact}} Risk management file: {{risk_impact}} Verification or validation: {{validation}} Existing stock: {{disposition}} #### Impact Checklist **Table:** **Columns:** - Area - Affected (Y/N) - Owner - Action **Rows:** **0:** Design history file **0:** Labeling and IFU **0:** Process validation **0:** Supplier quality agreement **0:** Training #### Approvals **Signatures:** - Requestor - Engineering - Quality assurance - Regulatory affairs - Operations **Notes:** 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. ## Content **Intro:** 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. **Sections:** #### How to use the form **Body:** 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 **Body:** 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. **Bullets:** - 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 **Body:** 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. **Cta:** If change requests live in email and ERP engineering change orders separately, Netray can help connect them. Ask for a short review. **Faq:** #### Is every change a design change? **Answer:** 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? **Answer:** 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? **Answer:** At minimum engineering, quality and regulatory, plus operations where manufacturing changes. Set the list in your procedure. #### What about emergency changes? **Answer:** Define an expedited route with after-the-fact documentation and the same assessment, never a bypass without records. ## Search terms change control form medical device, ECO template ISO 13485, design change request form, change control procedure template, regulatory impact assessment change, document change request form --- Talk to an engineer: https://netray.co/contact?intent=erp_ai | Machine catalog: https://netray.co/agent/catalog.json