Description:

This form controls pre-market design changes by documenting what changed, why it changed, and what evidence is needed to keep the DHF consistent.
• Capture Design Change Short Description, Change Owner, and Phase of Design Control.
• Record Origin and Reason of the Change and the full Description of the Change.
• Identify affected User Needs, Design Inputs, and Design Outputs.
• Run a structured Impact Assessment (intended use, performance, usability, safety, compliance).
• Define a dated Action Plan with owners, evidence, and “blocking for approval” flags.
• Confirm updates to risk management, traceability matrix, and D&D plan where applicable.
• Perform Design Change Review and approve transfer to DHF before Change Release.

Your needs:

• medical device design change aligned with ISO 13845 requirements
• medical device design change for MDR decision-making
• Reduce rework by aligning impacts, actions, and evidence early.

Use this form whenever a change arises during design and development before market release, especially when it may affect intended use, compliance, or verification/validation scope.

It ensures decisions are objective. An Impact Assessment documents what is affected and why it matters, while transfer to DHF confirms approved records are complete before release.
• Identify impacts on UR/DI/DO and the Traceability Matrix.
• Assess intended use, performance, usability, and safety impacts.
• Confirm regulatory strategy and standards impacts (incl. MDR roles).
• Define required new/updated verification, validation, or process validation.
• Require evidence-based closure before release.

Within Lexqara, we support design control, regulatory strategy, audits, and verification/validation planning so design change control stays lean and defensible. Use our Resource Center and Design Control Support for Start-up Companies, and consult EU MDR (Regulation (EU) 2017/745). Request a short design change impact review.

Done well, design change control protects timelines by keeping risk management updates, test scope, and DHF traceability aligned to one approved action plan.