This case study highlights the challenges, expertise, and detailed process involved in testing liquid hydrogen (LH₂) systems, based on the experience of Kiwa as an independent testing laboratory. To understand what this work entails, this case study takes you through the landscape in which LH₂ technology is developing, the capabilities of Kiwa, and the step-by-step testing process that customers rely on.
CPR-2024 is not just about what you provide, but why. The updated regulation goes beyond compliance, setting a clear path toward sustainable, circular, and transparent construction practices. Digital product passports, environmental data in the DOPC, and strengthened oversight will shape the industry.
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.
