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 used in neurology, orthopaedics, and oncology, MRI plays a critical role in modern diagnostic healthcare.
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Types of MRI Machines
🔹 Closed Bore MRI
The patient lies inside a narrow cylindrical tunnel surrounded by a superconducting magnet. These systems are widely used in hospitals and diagnostic centres, but can feel claustrophobic to some patients.
🔹 Open Bore MRI
These feature an open structure with magnets above and below the patient. They provide greater comfort for paediatric, elderly, and claustrophobic individuals, though sometimes with slightly reduced image quality.
Key Differences: X-ray vs CT Scan vs MRI
Modality | Image Type | Main Use | Radiation Use |
X-ray | 2D | Bones, lungs | Yes |
CT Scan | 3D | Organs & injuries | Yes |
MRI | 3D | Brain, spine, soft tissues | No |
MRI stands out for soft tissue contrast and radiation-free imaging, making it ideal for complex diagnostics.
How Are MRI Machines Manufactured?
MRI machine manufacturing involves precise engineering and integration of high-performance components:
1. Superconducting Magnet
Cooled with liquid helium, this powerful magnet creates a stable field inside a vacuum-sealed unit.
2. Gradient Coils
Crafted from copper or aluminium, these coils are essential for spatial encoding. They must be precisely wound and insulated for durability and accuracy.
3. RF (Radio Frequency) Coils
Placed close to the patient’s body, these coils transmit and receive MRI signals that form the image.
4. Control & Display Systems
Advanced software interprets signals into images. These systems must meet cybersecurity and interoperability standards under UK medical IT regulations.
Regulatory Landscape for MRI Machines in the UK
✅ UKCA Marking
MRI machines are Class IIb medical devices under UK Medical Device Regulations (UK MDR 2002, as amended). Manufacturers must secure UKCA certification through a UK Approved Body for legal market entry.
You can check our service page for more details on the UKCA for medical devices.
✅ MHRA Registration
The Medicines and Healthcare products Regulatory Agency (MHRA) oversees device registration in the UK. All manufacturers must register their products on the MHRA portal before placing them on the market.
You can check our blog page for more details on the MHRA medical device registration.
✅ QMS Requirement
Manufacturers must implement and maintain a UK-recognised Quality Management System (QMS), typically compliant with ISO 13485:2016.
How Operon Strategist Supports MRI Machine Manufacturing in the UK
Operon Strategist is a global medical device consultancy with a strong presence in the UK and 32+ other countries. We provide end-to-end solutions for MRI machine manufacturing, including:
✅ Turnkey Project Setup
✅ Regulatory Consulting & UKCA Certification
✅ Facility Design as per MHRA Requirements
✅ ISO 13485 QMS Implementation
✅ Clinical Evaluation Documentation
✅ Post-market Surveillance Support
Whether you are setting up a new diagnostic imaging unit or expanding your current facility to include MRI machines, our experts ensure regulatory compliance and business continuity throughout the entire process.
Manufacture Smart. Comply Globally. Operate Confidently.
Thinking of Entering the UK MRI Market?
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