Kiwa Medical

𝐍𝐚𝐯𝐢𝐠𝐚𝐭𝐢𝐧𝐠 𝐭𝐡𝐞 𝐜𝐨𝐦𝐩𝐥𝐞𝐱 𝐰𝐨𝐫𝐥𝐝 𝐨𝐟 𝐝𝐫𝐮𝐠-𝐝𝐞𝐯𝐢𝐜𝐞 𝐜𝐨𝐦𝐛𝐢𝐧𝐚𝐭𝐢𝐨𝐧 𝐩𝐫𝐨𝐝𝐮𝐜𝐭𝐬 Bringing a drug-device combination to market? Then you know how crucial it is to stay ahead of evolving regulations. The European Medicines Agency (EMA) plays a key role in defining compliance expectations, ensuring that these innovative products meet both medical device and pharmaceutical requirements. In our latest article, we break down the essential compliance aspects from the EMA and highlight what manufacturers need to know. 📖 Read more here:https://lnkd.in/eCj_Hvgd #MedicalDevices #Pharma #DrugDeviceCombination #RegulatoryCompliance #KiwaMedical 

𝐔𝐬𝐚𝐛𝐢𝐥𝐢𝐭𝐲 𝐢𝐧 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞𝐬: 𝐀 𝐜𝐫𝐮𝐜𝐢𝐚𝐥 𝐟𝐚𝐜𝐭𝐨𝐫 𝐟𝐨𝐫 𝐌𝐃𝐑 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 𝐚𝐧𝐝 𝐩𝐚𝐭𝐢𝐞𝐧𝐭 𝐬𝐚𝐟𝐞𝐭𝐲 For medical devices, usability is not just about convenience—it’s about safety, effectiveness, and compliance. The EU Medical Device Regulation (MDR) places strong emphasis on usability engineering to minimize risks and enhance patient outcomes. In our latest article, we explore: ✅ Why usability is essential for MDR-compliance ✅ Key aspects of usability engineering ✅ How manufacturers can integrate usability early in development Ensuring that medical devices are functional and safe is not just a regulatory requirement—it’s a responsibility. Read more about how usability plays a key role in compliance and patient safety: 🔗 https://lnkd.in/e8S-dyvA #MedicalDevices #MDR #UsabilityEngineering #PatientSafety #RegulatoryCompliance #KiwaMedical

𝐏𝐑𝐑𝐂 𝐯𝐬 𝐔𝐊𝐑𝐏: 𝐔𝐧𝐝𝐞𝐫𝐬𝐭𝐚𝐧𝐝𝐢𝐧𝐠 𝐭𝐡𝐞 𝐤𝐞𝐲 𝐝𝐢𝐟𝐟𝐞𝐫𝐞𝐧𝐜𝐞𝐬 𝐢𝐧 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧 Regulatory professionals, let's clarify the distinction between the Responsible Person for Regulatory Compliance (PRRC) under EU MDR and the UK Responsible Person (UKRP) under UK regulations. ➡ The PRRC plays a broad regulatory role within an EU medical device manufacturer’s organization, ensuring compliance with conformity assessments, technical documentation, and post-market surveillance obligations. ➡ The UKRP, on the other hand, is primarily a market access facilitator for non-UK manufacturers, acting as their legal representative and ensuring compliance with UKCA marking requirements. Understanding these roles is key to ensuring smooth regulatory navigation across different markets. 📖 Read more in our full article here: https://lnkd.in/e6FBepS8 #PRRC #UKRP #MedicalDevices #MedicalDeviceRegulation #UKCA #KiwaMedical 

𝐎𝐟𝐟-𝐥𝐚𝐛𝐞𝐥 𝐮𝐬𝐞 𝐨𝐟 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞𝐬: 𝐈𝐦𝐩𝐥𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬 𝐚𝐧𝐝 𝐜𝐨𝐧𝐬𝐢𝐝𝐞𝐫𝐚𝐭𝐢𝐨𝐧𝐬 Off-label use refers to the use of a medical device for a purpose, in a way, or with a patient population that is not explicitly specified in the device's approved instructions for use (IFU). While seemingly a deviation from intended use, off-label use is a practice in medicine, driven by factors such as the lack of approved alternatives for certain conditions, the emergence of new scientific evidence, or the need to address unique patient needs. However, off-label use carries inherent risks and implications. Firstly, safety and efficacy data may be limited or non-existent for the off-label indication, potentially exposing patients to unforeseen risks. Secondly, using a device outside its approved parameters may void warranties and potentially impact the manufacturer's liability. Clinicians utilizing off-label devices bear a significant responsibility. They must carefully weigh the potential benefits against the risks, ensure informed patient consent, and maintain thorough documentation of the off-label use. Manufacturers also play a crucial role. While not directly involved in off-label use decisions, they have a responsibility to provide clear and comprehensive IFUs, support post-market surveillance activities, and engage in ongoing research to expand the approved indications for their devices. Regulatory bodies strive to balance the need for innovation and access to novel therapies with the need to ensure patient safety. They may issue guidance documents on specific off-label uses, encourage post-market data collection, and support research initiatives to investigate the safety and efficacy of off-label applications. We, as Notified Bodies need to understand how the manufacturers addresses the off-label use of their devices.  Off-label use of medical devices presents a complex challenge that requires careful consideration by all stakeholders. Open communication between clinicians, manufacturers, and regulatory bodies is essential to ensure safe and effective patient care while fostering innovation in the medical device field. #Kiwamedical #Kiwa #MedicalDevices #Safety #OffLabel

🌍 𝟏𝟏 𝐋𝐨𝐜𝐚𝐭𝐢𝐨𝐧𝐬, 𝟐𝟎+ 𝐜𝐮𝐥𝐭𝐮𝐫𝐞𝐬, 𝐨𝐧𝐞 𝐠𝐨𝐚𝐥: 𝐄𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐜𝐞 𝐢𝐧 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞𝐬! Our annual hybrid Calibration Days, where professionals from diverse backgrounds come together to discuss the latest in Medical Devices, MDR, and the new MDCG’s. This year, we're thrilled to be hosted by the Notified Body Kiwa Dare in Woerden. ✨ Inspiring days of learning and connection! ✨ Let's meet, learn, and elevate our industry standards together. #MedicalDevices #Calibration #KiwaMedical #MDR #MDCG

𝐊𝐢𝐰𝐚 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐈𝐧𝐬𝐢𝐠𝐡𝐭 𝐢𝐧𝐭𝐨 𝐄𝐮𝐫𝐨𝐩𝐞𝐚𝐧 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐍𝐨𝐦𝐞𝐧𝐜𝐥𝐚𝐭𝐮𝐫𝐞 (𝐄𝐌𝐃𝐍) In January 2025, the Medical Device Coordination Group updated the document MDCG 2021-12 “FAQ on the European Medical Device Nomenclature (EMDN)” now in Revision 1. The European Medical Device Nomenclature (EMDN) is requested in Article 26 of Regulation 2017/745 as a way “to facilitate the functioning of the European database on medical devices (‘Eudamed’)”.  Based on the previous CND system (used in Italy, Portugal and Greece), EMDN is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. It’s hence an important responsibility of manufacturers, to identify the correct EMDN code for their medical devices. The revised MDCG 2021-12 now adds two very important question (and related answers): “How many EMDN codes can I assign to each UDI-DI” and “In case of changes in EMDN (new codes, split codes, obsolete codes), when do manufacturers need to update the relevant code(s)?”. For more information: Contact us to get your application trough 𝐦𝐞𝐝𝐢𝐜𝐚𝐥@𝐤𝐢𝐰𝐚.𝐜𝐨𝐦 #KiwaMedical #MedicalDevices #EMDN

🔒 Cybersecurity in Healthcare: A European Action Plan 🔒 Digitalization is transforming healthcare, from electronic health records to AI-driven diagnostics. But with innovation comes risk—cyber threats targeting hospitals and healthcare providers are on the rise. In 2023 alone, 309 cybersecurity incidents were reported in the sector, with 54% involving ransomware attacks. To strengthen resilience, the EU is rolling out a European Action Plan for Healthcare Cybersecurity. Read our latest document for more information. Source: https://lnkd.in/eCXS6_sV #KiwaMedical #Kiwa #Cybersecurity #DigitalEU #MedicalDevices

𝐇𝐚𝐫𝐦𝐨𝐧𝐢𝐳𝐞𝐝 𝐬𝐭𝐚𝐧𝐝𝐚𝐫𝐝𝐬 𝐮𝐧𝐝𝐞𝐫 𝐭𝐡𝐞 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧𝐬: 𝐊𝐞𝐲 𝐟𝐚𝐜𝐭𝐬 For manufacturers and stakeholders in the medical device industry, harmonized standards provide a clear pathway to compliance with the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). These standards offer a presumption of conformity, making regulatory approval more efficient. 📌 Key aspects of harmonized standards: ▪️ Developed by CEN and CENELEC at the request of the European Commission. ▪️Commission request: Initial request issued in 2021, with amendments in 2023 and 2024. ▪️Published in the Official Journal of the European Union. ▪️Presumption of conformity: Compliance with these standards supports regulatory approval. ▪️Applicable to Medical Devices and IVDs under MDR (EU 2017/745) and IVDR (EU 2017/746). ▪️Multiple implementing decisions: Standards are referenced in the Official Journal. ▪️Available on eNorm Platform, including all amendments. ▪️Consolidated version available for reference. ▪️Summary lists of published standards are available on the Commission’s website. ▪️Key benefits: Streamlines conformity assessment and facilitates market access. Do you have questions or require more information? Do not hesitate to reach out to 𝐦𝐞𝐝𝐢𝐜𝐚𝐥@𝐤𝐢𝐰𝐚.𝐜𝐨𝐦 Source: https://lnkd.in/eG9TTNqA #KiwaMedical #MedicalDevices #Standards 

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. Understanding the distinctions and similarities between OOS and deviations, as well as having robust processes to address them, is essential for ensuring the consistent production of safe, effective, and high-quality medical devices. In our latest article, we’ll delve into the key differences, similarities, and step-by-step approaches to effectively manage OOS events and deviations, emphasizing the importance of thorough investigation, corrective actions, and preventive measures. 👉 Let’s explore how these events are managed to uphold quality and compliance in the medical device sector: https://lnkd.in/eUngKAME #MedicalDevices #KiwaMedical #Deviations #OOS

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. Additionally, conducting the EN IEC 60601-1 standard test is necessary to verify compliance and demonstrate that the device meets these stringent requirements. 👉 Dive into our latest article for detailed insights and information:  https://lnkd.in/eskUmq67 #KiwaMedical #MedicalDevices #ElectricalSafety #Kiwa