Latest news from Kiwa

The plastics industry is transforming, with recycling and sustainability at the heart of its future. As regulations become stricter and consumers demand more environmentally friendly solutions, ensuring quality, compliance, and innovation in recycled plastics is more important than ever.

Kiwa, DVGW CERT, and figawa are launching the Fit4DW materials database at ISH 2025. This platform simplifies the certification of drinking water materials, ensuring compliance with EU regulations. By centralizing verified data, it reduces certification time by up to nine months, saving costs while ensuring safe, high-quality water.

Registration of certain medical devices which are reusable Class I devices, upclassified Class I devices, and/or reliant on expired/expiring CE certificates in Great Britain (GB) and Northern Ireland (NI).

Kiwa and Vinçotte are proud to be key partners in the Horizon Europe SYRIUS project, which aims to revolutionize steelmaking by integrating hydrogen into the production process. This groundbreaking initiative will significantly reduce CO2 emissions and improve energy efficiency. With Kiwa's expertise in safety and certification, and Vinçotte’s focus on compliance, the project sets new standards for sustainable steel production and industrial innovation.

A new revision of Questions & Answers for applicants, marketing authorization holders of medicinal products and notified bodies with respect to the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746) has been published.  

In the ever-evolving field of medical technology, usability engineering has become a critical factor in ensuring patient safety and regulatory compliance. The MDR (Medical Device Regulation) places a strong emphasis on usability engineering. Compliance with IEC 62366-1 and IEC TR 62366-2 is not just a regulatory requirement but also a best practice for designing medical devices that are safe, effective, and user-friendly.

Kiwa Creiven joins Heat Pump KEYMARK as its 30th testing lab, strengthening quality assurance and reliability in heat pump certification.

Two key roles in the medical devices sector are the Responsible Person for Regulatory Compliance (PRRC), which is a requirement under the EU MDR (2017/745) and IVDR (2017/746), and the UK Responsible Person (UKRP), which is mandated under the UK MDR 2002 (SI 2002/618, as amended). While their names may sound similar, their responsibilities and legal implications are quite different.

In the medical device industry, maintaining quality and compliance is paramount to ensure patient safety and product efficacy. Two critical concepts that often arise in this context are Out-of-Specification (OOS) events and Deviations. While both indicate potential quality or compliance concerns, they differ significantly in their focus, triggers, and resolutions.

EN IEC 60601-1, Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance, is a harmonized standard that outlines the essential safety and performance criteria for active medical devices. Incorporating this standard during the design phase of electrical medical devices is crucial.