Kiwa Stories - Articles

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 today’s complex global food supply chain, product recalls are no longer rare exceptions—they are a reality. Contamination, mislabeling, or regulatory non-compliance can trigger recalls with significant impact on producers, retailers, and consumers.

Explore what utility mapping is, its role in underground utility detection, and how technologies like SUE and HDD 3D modeling improve accuracy. Learn the risks, limitations, and importance of professional oversight in preventing costly utility strikes.

In today’s fast-moving packaging and branding industry, digital trust is no longer a technical side note. It’s a commercial necessity. For Esko, a global leader in packaging technology with roots in Ghent, Belgium digital trust has evolved into a strategic differentiator. Recently, Vinçotte, a Kiwa company, spoke with Esko’s CDTO and CMO to learn how they’re approaching this challenge.

The revised Construction Products Regulation (CPR-2024) is already in effect, yet many manufacturers still operate under outdated assumptions. From the phased rollout and new environmental requirements to the expanded scope and responsibilities, it’s time to separate fact from fiction. In this article, we unpack the 7 most common misconceptions about the new CPR law—and what you actually need to do to stay compliant.

The AIB 2025-1 MDCG 2025-6 guidance document represents a major milestone for medical device manufacturers across the European Union. It clarifies the interplay between the Medical Device Regulation (MDR), In Vitro Diagnostic Medical Device Regulation (IVDR), and the newly adopted Artificial Intelligence Act (AIA, offering comprehensive direction for compliance in this emerging landscape.

With Kiwa Certification, plastics processors demonstrate their commitment to sustainability and prepare for future legislation

Discover how Vinçotte’s professional on-site inspections help festival organizers across Europe secure tents, stages, and electrical setups to create safe environments for visitors and crew. Avoid risks, stay compliant, and ensure a successful event with expert guidance.

At Approach Cyber, trust by design means embedding security, privacy, and transparency into every layer of the organization – not just the code. From ISO certifications to an open culture, discover how they turn trust into action.

Under the European Union's medical device regulations, MDR (EU 2017/745) and IVDR (EU 2017/746), it has become mandatory for all devices to be included in a common classification system. This classification system is defined as the European Medical Device Nomenclature (EMDN) and plays a critical role in the placing of devices on the market, traceability and technical file content.

In 2025, food safety isn’t just about hygiene—it’s about trust, transparency, and integrity. That’s why leading food safety certification schemes recognized by the Global Food Safety Initiative (GFSI) have embedded food fraud prevention directly into their core requirements.

For small and medium-sized enterprises, the effort required to meet regulatory requirements from the EU is challenging. With the so-called omnibus procedure presented in February, the requirements could be significantly minimized in the future. Raoul Mancke, Kiwa’s Sustainability and ESG expert, comments on both the proposal and the new Clean Industrial Deal, in an interview conducted by Volker Laengenfelder on behalf of We Care.

One of the major changes within the pest management industry over the last few years has been the increased number of restrictions, particularly relating to anticoagulant rodenticides. This poses significant changes for pest management practices across various industries with further restrictions and changes possible. Understanding these regulations and planning ahead will help businesses maintain compliance, while ensuring effective rodent control. This article outlines the key regulatory updates and practical steps to adapt to these changes.