Latest news from Kiwa

Kiwa announces the launch of Kiwa India Medical, a new business dedicated to medical device certification and regulatory assurance in India. This initiative aims to provide manufacturers with reliable, transparent, and efficient certification services, supporting their access to global markets.

Kiwa was proud to participate in the GRIT Gandhinagar 2026 conference, “Gujarat to Global: Empowering the MedTech Ecosystem,” held on 23 June 2026 in Gandhinagar, Gujarat, India. The event brought together policymakers, regulatory experts, industry leaders, and medical device manufacturers to discuss how India’s rapidly growing MedTech sector can strengthen its position in global markets.

The MDCG published MDCG 2026-4 – Management of SS(C)P in EUDAMED after mandatory use in June 2026. The document explains how SSCP documents will be managed in EUDAMED during the transition following the start of mandatory use on 28 May 2026.

The Position Paper “MDR Certification Process (including Pre-application, Application and Post Application phases) – Consensus document” was adopted by the Team NB members and published on December 18th 2024.  This Position Paper is applicable to both legacy devices (pursuant to Article 120) transitioning to MDR, and devices that are new to the market and have not been certified under the Directives before and is aligned to the requirements of MDR

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.

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.

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.

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.  

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.​  

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).