Medical device management is the system a healthcare organisation uses to make sure its medical equipment is suitable, safe, properly maintained and used correctly, from the moment a need is identified until the device is disposed of. In the UK, the core reference is the MHRA’s guidance Managing Medical Devices: Guidance for health and social care organisations. It sets out “a systematic approach to the acquisition, deployment, maintenance (preventive maintenance and performance assurance), repair and disposal of medical devices.”

This guide works through each stage of the medical equipment lifecycle. It covers what the MHRA guidance recommends and the practical questions clinical engineering, EBME, procurement and governance teams need to answer along the way.

What is medical device management?

Medical device management covers the policies, people, records and processes that keep an organisation’s medical equipment fit for use throughout its working life. It applies to everything from infusion pumps and patient monitors to hoists, wheelchairs and large imaging installations.

The MHRA guidance is aimed primarily at people in hospital and community-based organisations who are responsible for managing medical devices. In vitro diagnostic (IVD) devices are covered by separate MHRA guidance, and not every section applies to implantable devices.

The medical equipment lifecycle at a glance

The MHRA guidance asks organisations to cover the whole equipment lifecycle in their device management policy, “including selection, acquisition, acceptance, maintenance, repair, monitoring, traceability and disposal/replacement.”

Who is responsible for medical device management?

Responsibility starts at board level. The MHRA guidance says healthcare organisations “should appoint a director or board member with overall responsibility for medical device management”, with clear lines of accountability up to the board. Those lines may need to extend to independent contractors, community services, care homes and Private Finance Initiative (PFI) organisations, where they use or manage devices on the organisation’s behalf.

The guidance also recommends:

• Medical Device Safety Officers (MDSOs): named people whose role includes reporting adverse incidents to the MHRA.
• A medical devices management group: a multidisciplinary group that develops and reviews policy. Suggested membership includes clinical staff, clinical and biomedical engineering, clinical trainers, infection control, decontamination, risk management, estates and maintenance, IT and data support, purchasing, device users and MDSOs.
• A device management policy: covering responsibilities, decontamination, the equipment lifecycle, risk management and incident reporting, training, records, outsourcing, deployment and tracking, and equipment financing.
• A long-term strategy: setting out medium- to long-term equipment requirements, “taking account of cost, performance and risk across the entire equipment lifecycle”, aligned with the organisation’s wider business plan.

The device inventory: why records matter

Every stage of the lifecycle depends on good records. The MHRA guidance says records should be held in one system wherever possible and protected so that changes don’t obscure earlier information.

Device records should provide evidence of:

• a unique identifier for the device, where appropriate;
• the purchase price;
• a full history, including the date of purchase and when it was put into use;
• 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.

Training records matter just as much. They should show that users know how to use the device safely, can carry out routine checks, have had relevant refresher training and are competent to use the device in their area.

A complete inventory also makes safety work faster. When a Field Safety Notice or National Patient Safety Alert arrives, knowing exactly which models are held, where they are and what software version they run is the difference between a targeted response and a hospital-wide search.

Stage 1: Planning and acquisition

Good lifecycle management starts before a purchase order is raised. The MHRA guidance recommends managing acquisition through “a multi-year investment and replacement plan”, with a prioritised schedule of short- to long-term equipment needs.

Think in whole-life cost

The guidance lists whole-life costs as “acquisition and operational, maintenance and consumable, training, risk, renewal and disposal costs.” This thinking sits at the heart of value-based procurement of medical technology.

Questions to ask before you buy

Drawing on the MHRA’s pre-acquisition factors, specification and evaluation should cover:

1. Does the device meet the agreed clinical requirement and the needs of its users?
2. Is it easy to use, and has it been designed to minimise misuse?
3. Are the instructions for use clear and complete?
4. What training is available, for users and for maintainers?
5. Can it be decontaminated with the processes and equipment you have?
6. Is it compatible with your IT systems, network and data security requirements?
7. What installation, utilities and commissioning does it need?
8. What maintenance does the manufacturer specify, and who can provide it?
9. How long will spare parts and service support be guaranteed?
10. Could better use of existing equipment, such as an equipment library, meet the need instead?

Standardise, but not blindly

Fewer models of the same device type reduce the risk of user confusion, simplify training and can save money. The guidance also warns against relying on a single model: it may prove unreliable, be recalled or be withdrawn. Where devices look similar but do different jobs, such as infusion pumps for epidural and patient-controlled analgesia, deliberately choosing different models may be safer.

Stage 2: Acceptance, commissioning and configuration

Acceptance checks confirm that what arrived is what was ordered, in good condition and working as the manufacturer describes. Finding a fault only when a device is first used can delay treatment and invalidate warranties.

Typical acceptance activity includes:

• checking the device against the purchase order or tender specification;
• confirming that instructions, certificates and accessories are included;
• adding the asset number, serial number and model details to the inventory;
• visual inspection, functional checks and electrical safety checks;
• recording baseline “as new” values to compare against at later maintenance;
• configuring the device to agreed clinical settings, signed off by a lead clinician.

Acceptance tests should stay within the bounds of normal use. The MHRA guidance points to BS EN 62353:2014, the standard for recurrent testing and testing after repair of medical electrical equipment, and notes that type tests from standards such as BS EN 60601-1 can damage the device under test.

Installed equipment needs an agreed commissioning procedure, with a designated member of staff responsible for confirming it is complete. Extra risk assessment is advised for second-hand devices, loaned devices, devices made in-house and devices under clinical investigation.

Stage 3: Training and instructions for use

Users need to understand how the manufacturer intends a device to be used, its controls, alarms and limitations, the checks and cleaning it needs, and what to do when it isn’t working properly. Maintenance and repair staff need training proportionate to the work they do.

The MHRA guidance recommends a training policy, set by the medical devices management group, that covers new staff, agency, locum and on-call staff, contractors, refresher training and updates after software upgrades. Training should be recorded, both centrally and by individuals.

Instructions for use also need controlling. Organisations should be able to track which versions have been issued and replace them when manufacturers update them. Instructions that are unclear or inadequate should be reported to the MHRA as an adverse incident.

Stage 4: Maintenance and repair

The healthcare organisation is responsible for making sure its devices are maintained appropriately. The frequency and type of planned preventive maintenance should follow the manufacturer’s instructions, taking account of expected usage and the environment. The MHRA notes that service intervals typically range between 1 month and 2 years, depending on the device.

Choosing who maintains your equipment

Maintenance can be provided by the manufacturer, authorised service agents, third-party providers, in-house teams and, for routine checks, users themselves. Most organisations use a mix. The guidance is clear that “cost alone should not be the determining factor”, and recommends a risk-benefit analysis before finalising any service arrangement.

Whichever route you choose, the guidance notes that “if using an outside organisation, you need in-house expertise to monitor, audit and manage contracts.”

What a service contract should cover

Service contracts should reference the manufacturer’s instructions and set out spare parts sourcing and traceability, staff training, quality management systems, record keeping, information governance, subcontracting, response times, loan devices and disposal of obsolete parts and waste.

Spare parts and traceability

Parts should match the manufacturer’s specification. Using alternative parts needs a documented risk assessment, and pre-used parts should not normally be used. Critical parts should be traceable back to their supplier, so affected devices can be found quickly if a part is recalled.

Stage 5: Monitoring, utilisation and safety

Lifecycle management does not stop once equipment is in service. The MHRA guidance recommends that organisations:

• monitor utilisation, and redeploy under-used equipment where possible;
• report adverse incidents, including near misses, user problems, software failures and issues with instructions, through local procedures and to the MHRA;
• distribute safety information, including Field Safety Notices and MHRA safety messages, to the right people, and record the action taken;
• audit regularly, with the medical devices management group reporting to the board;
• use key indicators that show improvement or give early warning of risk, and consider benchmarking against other organisations.

In England and Wales, adverse incidents involving medical devices are reported through the MHRA’s Yellow Card scheme. Scotland and Northern Ireland have their own reporting centres. Post-market surveillance rules for manufacturers changed in June 2025. Our guide to UK medical device regulations explains what that means for Field Safety Notices.

Stage 6: Replacement, decommissioning and disposal

All devices eventually need replacing. The MHRA guidance recommends holding the expected lifecycle of each device in the inventory and reviewing it against usage, maintenance and repair history. Heavy use or irregular maintenance may shorten it; limited use may extend it.

When to replace

Replacement criteria in the guidance include:

• damage or wear beyond economic repair;
• poor reliability, shown by service history;
• clinical or technical obsolescence;
• loss of manufacturer or supplier support;
• unavailability of correct spare parts or specialist repair knowledge;
• user feedback and the benefits of newer models;
• utilisation and downtime;
• changes in clinical standards or service provision.

A manufacturer’s recall takes precedence over other considerations.

Decommissioning

Decommissioning “aims to make devices safe and unusable, while minimising damage to the environment.” It includes decontamination and making sure nobody can use the device inappropriately. Where a device stores patient-identifiable data, that data should be securely erased to an appropriate standard before disposal, so it is forensically unrecoverable.

Disposal, sale and donation

Manufacturers should be consulted on disposal methods. Some devices count as special waste, for example those containing certain batteries, coolants or radioactive sources.

Selling or donating used equipment needs care. The guidance notes there is no legislation specifically covering resale or reuse, but used devices must still be safe under other laws. A device that is not safe for your patients is not safe for anyone else’s. Donated or sold devices should go with a clear statement that they are used, a decontamination certificate, user manuals, maintenance requirements, service and usage history, and relevant safety updates. A device that is fully refurbished and placed on the market falls under the UK Medical Devices Regulations 2002 (UK MDR 2002) again.

Which regulations apply to medical device management?

No single law governs how a healthcare organisation manages its equipment. Several apply together.

• Health and Safety at Work etc. Act 1974 and the Provision and Use of Work Equipment Regulations 1998: general duties to provide and maintain safe equipment and adequate training.
• Electricity at Work Regulations 1989: the basis for electrical safety testing and inspection programmes.
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 15: in England, the Care Quality Commission (CQC) regulation on premises and equipment, which requires equipment to be suitable, properly used and properly maintained. Scotland, Wales and Northern Ireland have their own regulators.
• UK MDR 2002: applies when an organisation modifies devices or makes them in-house and supplies them to another legal entity, and to full refurbishment.
• Device-specific legislation: such as the Ionising Radiations Regulations 2017 and the Lifting Operations and Lifting Equipment Regulations 1998, whose tests apply in addition to manufacturer maintenance, not instead of it.

Discuss medical equipment management at EBME Expo

Medical device management depends on collaboration between engineers, clinicians, procurement teams, IT specialists and suppliers. At EBME Expo 2027 (23–24 June, Coventry Building Society Arena), you can compare equipment and service options, ask manufacturers about maintenance, training and whole-life support, and hear how other organisations approach equipment management.

This article is general information, not legal or regulatory advice. Follow your organisation’s policies and the manufacturer’s instructions, and seek specialist advice for specific devices and situations.

Sources: Managing medical devices (MHRA, updated 25 February 2021) · Managing Medical Devices: Guidance for health and social care organisations, v1.3 (MHRA, January 2021) · Yellow Card scheme (MHRA)