Latest news from Kiwa

Artificial Intelligence (AI)-based software medical devices are revolutionizing the healthcare sector in diagnosis, treatment, and patient management. AI-powered Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) applications cover a wide range of solutions, from medical decision support systems to patient monitoring tools.

The rules for placing medical devices on the Great Britain (GB) and Northern Ireland (NI) markets differ primarily in terms of the timelines and regulatory frameworks

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.

Kiwa has retained its 5-star BRCGS rating across multiple countries, reaffirming its commitment to food safety and quality assurance. This recognition highlights Kiwa’s excellence in compliance, auditing, and supply chain integrity. Discover how Kiwa continues to support global food safety with trusted certification and verification services.

The Health and Youth Care Inspectorate (IGJ) has identified significant deficiencies in post-market surveillance (PMS) among medical device manufacturers in the Netherlands.​ IGJ urges manufacturers to prioritize PMS, enhance their knowledge, and ensure compliance to improve device safety and performance.​  

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.