Kiwa Stories - Articles

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.

Discover how AI and advanced imaging are reshaping concrete inspections—making them safer, faster and more cost-effective.

In a world where transparency and integrity are non-negotiable, Chain of Custody (CoC) certification is becoming a strategic asset for food businesses. Whether you're handling fresh produce or seafood, CoC standards like GLOBALG.A.P. and MSC help ensure that certified products remain authentic, traceable, and undiluted throughout the supply chain.

For seasoned professionals in food safety and quality, this isn’t just a supply chain. It’s a risk landscape. Every product represents a journey through raw materials, feed, farming, processing, packaging, logistics, and retail. And every step must be controlled, certified, and transparent.

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.

With the introduction of the revised Construction Products Regulation (CPR), a lot is changing for manufacturers of construction products. The updated CPR will take effect gradually, depending on the product group. But what exactly does this European legislation entail? What can you expect? And why is it smart to start preparing now?

Hydrogen is powering the future of mobility and energy storage—but getting your tanks and components certified is complex. Kiwa offers a complete solution, guiding manufacturers from design and testing to certification and production quality assurance, ensuring safety, compliance, and global market readiness.

Ever wondered what it takes to ensure products are safe, reliable, and certified? Follow Jürgen Koeneman, Kiwa’s Product & Installations Engineer, as he takes you behind the scenes of inspections, installations, and quality checks that protect homes and businesses worldwide.

Hydrogen’s future depends on safety — at Kiwa’s hydrogen laboratory, we test and certify tanks under extreme conditions to ensure reliable, leak-tight, and market-ready solutions.

Any medical device that makes use of software, or is a software in itself (MDSW), could potentially fall under the Regulation 2024/1689 (informally known as ‘AI act’), if the software, or part of it, meets the definition as laid down in this Regulation*. For devices falling under the AI Act, the deadline of August 2, 2027, is fast approaching, considering the timelines for conformity assessment.  

As a medical device manufacturer, choosing the right Notified Body is a critical strategic decision. You need a partner that not only understands the regulatory landscape but also operates with the highest standards of quality. It's not just about ticking boxes, it's the bedrock of trust we build with you, the medical device manufacturer, ensuring that when we give a medical device the thumbs up, it's genuinely safe and performs as it should.

Food safety is a non-negotiable priority for Astra Sweets, a confectionery producer with sites in Belgium and the Netherlands. For over a decade, the firm has been relying on our colleagues at Vinçotte Belgium, part of the Kiwa Group, to maintain the highest food safety standards – ensuring compliance as well as reaping tangible business benefits.

Hydrogen technology is developing at lightning speed, especially in the automotive sector. However, innovations are regularly delayed or even brought to a halt due to complex and internationally varying regulations. This is particularly true for systems with pressure components or mobile applications, where the requirements differ greatly by region and application. Kiwa expert Leendert van der Marel therefore advocates a clear approach: design hydrogen systems with regulations in mind from the very beginning. 

In July 2025, the International Organization for Standardization (ISO) released a full revision of the ISO 22002 series. At the centre of this update is ISO 22002-100:2025, a new foundational standard that redefines how prerequisite programs (PRPs) are structured and applied. For professionals working in food safety it is more than ‘just another update’. It’s a strategic shift.