Why Timely Notification of Change Matters in Medical Device Certification
At Kiwa Assurance, we recognize that innovation is a constant in the medical device industry. But change comes with responsibility—especially when it comes to maintaining compliance under the MDR and ISO 13485.
That’s where our Notification of Change (NoC) process plays a vital role.
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.
Note 1:
Substantial changes shall be approved by Kiwa Assurance before implementation.
Note 2:
Acting prematurely can invalidate your certificate and lead to regulatory consequences.
Note 3:
Kiwa Medical Device Certification
Medical devices placed on the European market must comply with the Medical Device Regulation (EU) 2017/745 (MDR). This regulation ensures that devices meet high standards of safety and performance.
