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Medical devices

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Tag: Medical devices
Page 2
12Jul 2024
EU, General Information Cubicdesignz Comments: 0

Ensuring Compliance and Quality: The Role of CE Marking in Safeguarding Patient Safety

The CE marking signifies a medical device’s adherence to stringent European Union (EU) safety regulations. This compliance process, known as CE marking compliance for patient safety, is critical in ensuring the quality and effectiveness of medical devices. By mandating rigorous assessments, it directly impacts patient safety. Manufacturers must demonstrate their devices meet essential safety and performance requirements, minimizing risks associated with malfunction, biocompatibility issues...
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05Feb 2024
EU, General Information, Regulations, UK Cubicdesignz Comments: 0

Exceptional Use Medical Devices in the EU and UK

Medical devices conforming with the medical device regulations must have a conformity marking. Medical devices that do not conform may still be placed in the market, provided they apply through the exceptional use devices pathway. This article discusses the exceptional use requirements to be satisfied to gain access to EU and UK markets. In the UK, the UKCA marking displays that the device conforms to UK Medical Device Regulations 2002. Without UKCA marking, the devices can only be placed in the...
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05Feb 2024
EU, Regulations, Swiss, UK Cubicdesignz Comments: 0

SaMD Devices Classification

SaMD is software intended for one or more medical purposes that perform these without being part of a hardware medical device. Medical device software is meant to be used, alone or in combination, for a purpose specified in the definition of a “medical device” in the MDR or IVDR, regardless of whether the software is independent or driving or influencing the use of a device. You can read more on the SaMD Regulation here. To be qualified as medical device software, the product must first...
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05Feb 2024
EU, Regulations Cubicdesignz Comments: 0

Cybersecurity for medical devices in Europe

EU Cybersecurity laws for Medical devices are advancing, and the use of software medical devices is also increasing daily. The increased interconnection of medical devices to computer networks and technological convergence have made devices and software programmes vulnerable to mishaps. The importance of protecting patient data from cyber-attacks is now well recognised. With the advancement of software as a medical device, proper regulations must be established to ensure the safety and security...
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05Feb 2024
EU, News, Regulations Cubicdesignz Comments: 0

Risk Management of medical devices under MDR

All medical devices are associated with inherent risks of some level. It is imperative to understand the medical device’s specific risks to a patient. Under EU MDR 2017/745, risk management is a continuous and iterative process. Manufacturers are expected to plan, document, and implement risk management strategies in this process. These strategies may either eliminate the risk or mitigate the overall severity of the risk. Medical Device Risk- Definition      ...
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