Change Assessment & Lifecycle Control
We assess the regulatory impact of engineering, supplier, manufacturing, software and labeling changes before implementation — determining whether a modification requires prior Notified Body approval or internal technical documentation updates.
The 6-Step Regulatory Decision Logic
Proposed Change Definition
Impact on Intended Purpose & Design
Risk & Evidence Impact Assessment
V&V / Clinical Testing Need
Technical File & QMS Update
NB Notification / Registration Action
10 Change Categories We Evaluate
Protecting Certificate Validity Before Tooling Changes
Implementing a significant change without mandatory Notified Body notification can result in immediate certificate suspension. We provide rigorous, documented regulatory impact assessments that justify whether a change is substantial under MDCG guidance.
MDCG Change Guidance
MDCG 2020-3: Significant changes regarding the transitional provisions for MDR
MDCG 2022-6: Significant changes under IVDR Article 110
Notified Body Prior-Approval: Required for substantial design, material or intended-use expansions.
Assess a Proposed Change
Evaluate whether your upcoming device modification triggers Notified Body notification.
Request Change AssessmentMaintain Continuous CE Mark Conformity Through Every Device Evolution
Our regulatory lifecycle consultants provide defensible change impact evaluations and Notified Body notifications.