Latest news from Kiwa

What are the requirements for registering medical devices with MHRA?

To register medical devices with the MHRA, manufacturers must follow specific requirements and procedures.  In this article you will find the key steps and requirements.

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Kiwa Retains 5-Star BRCGS Rating for Another Year

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.

Importance of and effective Post Market Surveillance (PMS) – The view of the Dutch Competent Authority (IGJ).

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.​  

Navigating the Regulatory Landscape for Drug-Device Combinations: Key Highlights and Compliance Essentials from EMA (European Medicines Agency)

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.  

Enhancing usability in medical devices: A key to MDR compliance and patient safety

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

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

PRRC vs UKRP: Navigating medical device regulatory responsibilities

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.

Understanding OOS and Deviations in the Medical Device Industry

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.

Key Considerations for EN IEC 60601-1 Testing

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.

What is Clinical Evaluation Equivalence and does that apply to your medical device?

Are you considering substantiating the clinical data of your device based on an equivalence device? Do you have full access to clinical data for technical, biological and clinically similar devices and you wish to leverage that to prove compliance for another device?  This article could help you get a feeling of whether this could be an option.

Heat Pump – Performance test laboratory now operational

We're excited to announce that Kiwa’s new Heat Pump Performance Test Laboratory in Padua is now operational. Equipped for EN 14511, EN 14825, and EN 16147 tests, it ensures high accuracy, automated processes, and ISO/IEC 17025 accreditation. With cutting-edge facilities, Kiwa is able to support reliable, sustainable heating and cooling solutions.

Position Paper of Team NB adopted: MDR Certification Process (including Pre-application, Application and Post Application phases)

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

Wergeland Bedriftsutvikling becomes part of Kiwa

Kiwa Norway expands by welcoming Wergeland Bedriftsutvikling AS (WBU) into the group. With expertise in management systems, risk mapping, and digital solutions, WBU strengthens Kiwa’s service portfolio. Together, they’ll offer enhanced services in sustainability, cyber security, and energy management, driving value and innovation for customers across various industries.

EU: Commission publishes second draft of GPAI (General Purpose Artificial Intelligence) code of practice

On December 19, 2024, the European Commission published the second draft of the 'General-Purpose AI Code of Practice.' Independent experts present the second draft of the General-Purpose AI Code of Practice, based on the feedback received on the first draft, published on 14 November 2024. 

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