The EU Carbon Border Adjustment Mechanism (EU-CBAM) is a key instrument of the European Union aimed at preventing carbon leakage and ensuring fair competition between EU manufacturers and importers from third countries. By aligning the carbon costs of imported goods with those produced within the EU, the mechanism supports the EU’s climate objectives while encouraging cleaner production globally.
Under Article 52 and Annexes IX through XI of the Medical Device Regulation (MDR), it is the legal manufacturer's responsibility to select the appropriate conformity assessment route. However, as a Notified Body, we often observe confusion regarding what these assessments entail and which route is best. The correct choice depends on the device classification and the level of control the manufacturer maintains over design and production.
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.
Kiwa’s livestreamed, cloud-based inspection solution brings together drones, real-time collaboration, AI-driven analysis, and centralized data to transform how industrial assets are inspected and managed—making inspections safer, faster, and more connected.
