Staying Aligned: Why Timely Notification of Change Matters in Medical Device Certification

Whether you're updating your quality management system, modifying a device’s intended purpose, or adding a new production site, it’s essential to notify us before implementing the change. Even seemingly minor updates can have a significant impact on your certification status, especially when they are noticed too late.

What types of changes require notification?

For example:

• Changes to your QMS that may affect compliance
• Modifications to device intended use
• Adjustments in manufacturing processes or critical suppliers
• Additions to your product range or Basic UDI

How does the process work?

Manufacturers submit a change notification form, which is reviewed by our experts. Depending on the nature of the change, this might lead to actions such as:

• A supplement or amendment to your certificate
• A new application review (for example, in case of scope expansion)
• Updates to your technical documentation sampling plan

Transparency and timely communication are key to support your innovation while safeguarding patient safety and regulatory compliance. Late submissions often lead to surprises that could have been avoided.

Important:

• The earlier you send us the notification, the earlier you’ll know what to expect. 
• Substantial changes shall be approved by Kiwa Assurance before implementation.
• Acting prematurely can invalidate your certificate and lead to regulatory consequences.

Note1 : The concept of a “significant change” is specific to MDD legacy devices and is defined under MDCG 2020-3. For MDR-certified devices, we assess substantial changes.

Note2 : Want to learn more about how we assess changes? Reach out to our team or consult the information package on our website.

Note3: The NoC process is subject to future updates in alignment with evolving regulatory guidance, including potential MDCG publications.