Guide · checked October 2026
Implant traceability and recall: UDI, registries and the cath lab
Unique device identification (UDI) is not yet in force in Great Britain, with future rules expected through further legislation in 2026, so cath labs currently rely on scanning the manufacturer's barcode, recording lot and expiry against each patient, and taking part in NHS England's Medical Devices Outcomes Registry where it applies.
UDI in Great Britain
The government's implementation plan for the future regulation of medical devices says future pre-market rules will require devices to have unique device identifiers, through a further statutory instrument in 2026, without a compliance date yet. The consultation explains the two parts: a device identifier (UDI-DI) for the manufacturer and model, and a production identifier (UDI-PI) for the serial or lot number, software identification and manufacture or expiry date.
New post-market surveillance rules took effect on 16 June 2025. Serious incidents must now be reported within 15 days rather than 30.
The Medical Devices Outcomes Registry
NHS England's Medical Devices Outcomes Registry (MDOR) was established in 2024 under the Outcomes and Registries Directions 2024, with submissions since April 2024. All providers of NHS-funded care, including the independent sector, that carry out surgical or interventional procedures with a Class IIb or III implantable device must submit data. Check the MDOR page for which procedures are in scope; it does not list cardiology procedures by name.
Making recalls fast
- Capture the device identifier, lot and expiry at the point of use, by scan.
- Store them against the patient and the procedure, not only in a stock system.
- Make the record searchable by lot so a recall can be answered in minutes.
- Record who confirmed each device, so exceptions can be followed up.
Common misreadings
- UDI is not yet a legal requirement in GB, but GS1 barcodes are already widely used.
- Being on a stock system is not the same as being traceable to a patient.
- MDOR scope is set by its own page and directions; check it rather than assuming.
Where Cath Copilot fits
Cath Copilot links each scanned device, with its lot and expiry, to the case, and offers implant recall search across all cases by lot number for the quality lead and operator. Every search is recorded in the audit log. It does not submit to MDOR or any registry.
Cath Copilot is a prototype on synthetic data only. It is not a medical device and is not for clinical use.
Questions
Is UDI mandatory in the UK yet?
Not in Great Britain yet. The government says future rules will require UDI through a further statutory instrument in 2026.
What is a UDI-PI?
The production identifier part of a UDI: serial or lot number, software identification and manufacture or expiry date.
Sources
Official pages, checked October 2026. Guidance changes, so check the current version before you rely on it.
- MHRA / gov.uk: Implementation of the future regulation of medical devices
- gov.uk: Consultation on the future regulation of medical devices, chapter 4 (registration and UDI)
- gov.uk: First major overhaul of medical device regulation comes into force (June 2025)
- NHS England: Medical Devices Outcomes Registry (MDOR)
General information for healthcare managers and clinical teams, checked October 2026. It is not legal, regulatory or clinical advice; follow the current official guidance and your organisation's own policies. No patient data is used in these examples. Cath Copilot is a prototype running on synthetic data only. It is not a medical device and is not for clinical use. It recommends, drafts, and routes; it never diagnoses, orders, or decides. A clinical safety and information-governance process precedes any use with real patient data.