MHRA Managing Medical Devices: Equipment Records Checklist

Quick answer: the MHRA guidance Managing Medical Devices (January 2021) asks health and social care organisations to keep device records in one system where possible, with each record showing a unique identifier where appropriate, purchase price, full history, legal requirements, installation and deployment, maintenance and repairs, and an end-of-life date if one is specified. It also asks for user training records and a record of where each device is, so safety notices reach the right devices. This checklist turns those points into questions for your register and for any software you evaluate.

This is a summary for buyers, not a replacement for the guidance. MHRA guidance does not approve or certify any software product.

What does MHRA Managing Medical Devices cover?

MHRA Managing Medical Devices covers the whole life of a reusable medical device: management systems, acquisition, training, decontamination, maintenance and repair, and disposal. Section 2.3 says a device management policy should address the equipment life cycle (selection, acquisition, acceptance, maintenance, repair, monitoring, traceability and disposal or replacement), risk management including National Patient Safety Alerts and manufacturers' Field Safety Notices, training, records including a device inventory, outsourcing, deployment and tracking, and financing.

Which records does MHRA expect for each medical device?

Section 2.4 says good record keeping is essential and that records should be kept in one system wherever possible, with cross references where they are not. Accurate copies must be available for inspection, for example by the CQC, internal audit or an investigation. The device records should provide evidence of:

• a unique identifier for the device, where appropriate
• the purchase price of the equipment
• a full history, including date of purchase and when it was put into use, deployed or installed
• any specific legal requirements and whether they have been met
• proper installation and where it was deployed
• the schedule and details of maintenance and repairs
• the end-of-life date, if specified

The guidance also says records must be protected so that changes do not hide earlier entries, and that they must be retrievable for the whole retention period. In software terms, ask for an audit trail rather than overwritten fields.

How does medical device management handle safety notices and location?

The guidance recommends a record of the current location of medical devices, so that safety communications and manufacturers' Field Safety Notices can be targeted, and a record of the action taken as a result. A register that shows department or ward for each device, and a recall log linked to the affected devices, covers both points.

• Record the department or ward for each device and update it on every transfer.
• When a Field Safety Notice arrives, list every affected device by model and serial number.
• Record the action taken and the date for each device, then close the notice.

A scheduled inventory scan gives a point-in-time location. Continuous location needs a separate RTLS installation; our CMMS vs RTLS guide explains the difference.

What training records are needed?

Healthcare organisations must keep records of user training. Section 2.4 says these should show that users know how to use the device safely, can carry out routine checks and maintenance, have had relevant refresher training, and are confident or competent in their area. Link training to the device type so you can see who is trained on which equipment.

What should a software demo prove for a UK organisation?

A demo should prove that one record holds the evidence MHRA lists, and that you can get it out for an inspection. Bring a short extract of your register with no patient data. Any step a vendor cannot show live is a question to settle in writing before you buy.

1. Open a device by its identifier or label scan and show purchase date, price, installation and location.
2. Show its maintenance schedule, a completed job and a repair.
3. Change a field and show the audit trail keeps the earlier value.
4. Log a Field Safety Notice against all affected devices and record the action taken.
5. Export the inventory and maintenance history for a CQC visit or internal audit.

Reviewing medical equipment management software? See how Assetly keeps device records, or book a demo and ask us to run these steps on your own register. We will tell you which steps work as shown and which need configuration.

What should you ask about hosting and support?

Ask where data is stored, which subcontractors process it and what support hours apply in UK time. If the system will connect to NHS patient data or systems, the Data Security and Protection Toolkit applies to organisations with that access; an equipment-only register may need a lighter review, so check the actual data with your information governance lead.

How Assetly maps to these records

Assetly is the hospital asset management product built by Nirmitee. It keeps an equipment register with manufacturer, model, serial number, department, purchase and warranty details, imports existing registers from a spreadsheet, and supports QR and barcode labels and handheld RFID checks. Maintenance work orders hold service history, spare parts, the person who did the work and time spent. Calibration records have due dates. There is an equipment recall module, transfer and movement history, an audit trail, and exportable reports for inventory, maintenance and PM compliance. On-premise deployment is available.

Ask us to show each item on your own data. Hosting, support hours and any UK-specific requirements are agreed per project; ask for them in writing.

Planning to connect equipment records with other systems? See our healthcare software product development services, or talk to our team.

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