What is an MRI Machine? An MRI (Magnetic Resonance Imaging) machine is a non-invasive diagnostic tool that uses strong magnetic fields and radio waves to generate detailed 3D images of the body’s internal structures. Unlike X-rays or CT scans, MRI does not use ionising radiation, making it safer for repeated scans and soft-tissue imaging. Widely […]
UK Medical Device Classification Navigating the UK’s medical device regulatory landscape can be overwhelming, especially following the UK’s departure from the EU. In this article, we’re breaking down the UK Medical Device Regulations 2002 (UK MDR 2002)—from classification basics to conformity assessment—so that manufacturers, distributors, and healthcare professionals can better understand their compliance obligations. What
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UKCA
An Overview: With the regulatory shift following Brexit, foreign medical device and IVD (in vitro diagnostic) manufacturers looking to enter the UK market must appoint a UK Responsible Person (UKRP) as mandated by the UK MDR 2002 (amended in 2019). This role is crucial for ensuring compliance with the Medicines and Healthcare Products Regulatory Agency
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UKCA
Introduction: Understanding UKCA Marking for Medical Devices With the UK’s exit from the EU, medical device manufacturers now need to comply with the UK Medical Devices Regulations 2002 (UK MDR 2002) to place their products on the market in England, Wales, or Scotland. A key part of this compliance is affixing the UK Conformity Assessed
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Regulatory Compliance
MHRA IVD Registration: An Overview Before placing medical devices or in-vitro diagnostic (IVD) devices on the market in Great Britain, manufacturers must comply with the MHRA IVD registration requirements. Governed by the UK Medical Devices Regulations 2002 (UK MDR 2002), this registration ensures that all medical devices and IVDs meet essential safety and performance standards.
Are you planning to launch your medical device in the UK? Understanding the MHRA medical device registration process is crucial for smooth market entry. In this guide, we’ll break down the registration process, costs, timelines, and key requirements to help you achieve compliance effortlessly. What is MHRA Medical Device Registration? MHRA registration is a legal
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Regulatory Compliance