Software & AI as a medical device
Detailed guidance on software as a medical device (SaMD) and artificial intelligence/machine learning (AI/ML) medical devices under the UK MDR 2002 — qualification, classification, technical documentation requirements, and MHRA's AI Change Programme.
Implantable devices
Regulatory requirements specific to implantable medical devices under the UK MDR 2002 — classification, additional Essential Requirements, implant cards, long-duration traceability, and vigilance obligations.
Devices incorporating a medicinal substance
How medical devices that incorporate a medicinal substance are regulated under the UK MDR 2002 — the device-led vs medicine-led determination, Class III classification, the role of MHRA, and practical examples including drug-eluting stents and antibiotic-impregnated devices.
Human tissue & cells components
Medical devices incorporating human tissue or cells — how they are regulated under the UK MDR 2002 in combination with the Human Tissue Act 2004 and MHRA/HTA oversight, and the distinction between device-led and transplant/therapy-led products.
Custom-made devices
The regulatory requirements for custom-made medical devices under the UK MDR 2002 — definition, who qualifies, the modified conformity assessment pathway, required documentation, and the distinction from standard devices adapted for individual patients.
Single-use devices
The regulatory framework for single-use medical devices in the UK — mandatory labelling, the prohibition on reprocessing and reuse, and the specific requirements for manufacturers who place reprocessed single-use devices on the GB market.
Systems & procedure packs
How systems and procedure packs are regulated under the UK MDR 2002 — the definition of a system or procedure pack, the obligations on the person assembling the pack, the statement required, and when a pack constitutes a new medical device.
Devices for export only
Regulatory requirements for medical devices manufactured in Great Britain for export only — what obligations apply, what obligations do not apply, MHRA's position on export certificates, and compliance with the destination country's regulatory framework.