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Choose an in vitro diagnostic (IVD) supplier by first defining the service you need, then checking the exact device’s regulatory status and clinical suitability, assessing the supplier and supply chain, and comparing implementation, support, resilience and whole-life cost. A conformity mark, quality certificate or framework listing is evidence for a particular check; none by itself establishes that a test is right for your service.
1. Define the service requirement before approaching suppliers
Start with the diagnostic service, not a preferred analyser or vendor. A clear requirement lets your laboratory, clinical, procurement and finance teams compare proposals on the same basis. MHRA procurement guidance is intended for people who purchase, supply, use, maintain and replace IVDs; it was last updated on 28 January 2021, so pair it with current device-legislation guidance when checking market access.
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Record the intended use and operating context, including:
- Tests and patients: the analytes or conditions to be tested, the patient groups, sample types and clinical decisions the results will inform.
- Setting and workflow: central laboratory, near-patient or point-of-care use; expected operating hours; who will run the tests; and how results move through the service.
- Demand: expected workload, peak demand, testing patterns and any need for urgent or out-of-hours capacity. Use local service data rather than a supplier’s assumptions.
- Performance and quality: the characteristics required for the proposed use, and how your clinical and laboratory teams will assess supporting evidence.
- Systems and implementation: required interfaces, data handling, space, utilities, installation, validation, staff training and transition from the existing service.
- Support and continuity: maintenance, service response and escalation arrangements, consumable availability, stock information and contingency plans.
Make each requirement specific enough to evaluate. For example, identify the systems an instrument must interface with and what evidence will demonstrate that the interface works in your environment. Set any local thresholds through the teams responsible for the service; there is no universal workload, response-time or stock threshold established for every IVD procurement.
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Read the MHRA’s IVD procurement, safety, quality and performance guidance.
2. Verify the exact device and its intended market
Check the proposed device by its exact model and intended purpose, not just the supplier’s product family or brand. The required conformity route and documentation depend on the device’s classification, intended use and market. MHRA’s legislation guidance, last updated on 15 January 2025, covers IVD controls for Great Britain under Part IV of the UK Medical Devices Regulations 2002, as amended. It also addresses scope, assessment and in-house manufacture.
Great Britain and Northern Ireland do not have identical marking rules. MHRA’s conformity-assessment guidance, last updated on 13 May 2026, explains that UKCA marking is used in Great Britain and that a UKCA mark alone is not sufficient to place a medical device on the Northern Ireland market under the described rules; CE marking continues to be needed there. Confirm the current requirements and any applicable transitional arrangements for the precise device and location before procurement, since market-access rules can change.
Ask the bidder for the documentation applicable to that device and route, such as its declaration of conformity, relevant certificates and evidence of registration where required. Check that the documents identify the model and intended purpose being offered. A certificate or marking is not a substitute for assessing whether the device’s intended purpose and performance evidence support your service’s proposed use.
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See MHRA guidance on IVD legislation and MHRA guidance on conformity assessment and the UKCA mark.
3. Assess supplier assurance separately from device compliance
A device’s conformity documentation addresses the product and its applicable regulatory route. A supplier’s quality-system certificate addresses a management system within the certificate’s scope. Neither one establishes the other, and ISO 13485 certification is not product authorisation or proof of diagnostic performance.
Request current quality-system certificates and check their validity, accreditation, scope and the organisations or activities they cover. Establish whether the evidence applies to the relevant manufacturer and to the distributor, storage and distribution parts of the supply chain involved in your contract. Also confirm who is responsible for product queries, maintenance, recalls or other escalation in the proposed arrangement.
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NHS Supply Chain specifies that suppliers seeking to participate in its relevant framework agreements provide valid, in-date BS EN ISO 9001:2015 or BS EN ISO 13485:2016 certification, accredited by UKAS or a recognised certification body, covering relevant parts of the tenderer and product supply chain. Its supplier page also describes requirements relating to declarations of conformity, MHRA registration and applicable conformity-assessment routes. These are stated requirements for that NHS Supply Chain context, not a blanket legal rule for every buyer. Check the tender terms that apply to your procurement.
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Check NHS Supply Chain’s contract and tender process requirements. MHRA’s conformity-assessment guidance explains the role of ISO 13485 for medical-device manufacturers’ quality-management systems and notes that use of designated standards is optional.
4. Compare proposals against the same criteria
For competing proposals, use a common requirement set and select evaluation questions proportionately to the cost, nature, complexity and risk of the procurement. The national value-based procurement guidance published on 11 June 2026 by DHSC, NHS England and NHS Supply Chain includes IVDs and point-of-care testing. It is a quality-assessment framework for specifying and evaluating tenders, not an end-to-end procurement procedure. Its five domains can help organise the comparison:
| Domain | What to assess for the proposed service |
|---|---|
| Purpose | Fit with the stated diagnostic need, intended use and required performance evidence. |
| Patient and staff | Effects on patients and staff in the intended setting, including workflow and training implications. |
| Efficiency | How the proposed solution fits the service workflow and uses resources across implementation and operation. |
| Supply chain | Availability of the device, reagents and consumables; lead times; contingency arrangements; and support continuity. |
| Social value | The social-value commitments and evidence relevant to the procurement and its evaluation criteria. |
Ask bidders to substantiate their claims, then have the appropriate local clinical, laboratory and finance teams validate the evidence. Compare whole-life cost rather than acquisition price alone. Include purchase costs and relevant post-warranty support costs, alongside other cost elements that apply to your contract. Set scoring criteria and any weightings for the specific procurement; do not assume a universal weighting for these domains.
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5. Test implementation, support and resilience
A proposal is only operationally credible if its promised service can work in your setting. Ask each bidder for evidence and commitments that can be checked during evaluation and, where appropriate, written into the contract.
- Implementation: a plan covering delivery, installation, validation, interfaces, training, handover and transition, with responsibilities identified for both supplier and buyer.
- Service support: maintenance arrangements, response and escalation routes, out-of-hours coverage if needed, and how service interruptions will be managed.
- Consumables and supply continuity: stock levels, stock coverage, lead times, contingency stock, supply diversity, alternative manufacturing arrangements and expected access to contingency supplies.
- Local fit: confirmation that the proposed workflow, facilities, data arrangements and staffing assumptions match the service requirements you defined.
- Costs over the service life: transparent pricing for the device, relevant consumables and support, including applicable post-warranty arrangements.
Use the answers to identify dependencies and risks, not just to collect general assurances. The required stock coverage, response arrangements and other acceptance thresholds depend on the service and should be set locally.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.6. Confirm the procurement route for your buyer and contract
NHS purchasing takes place at several levels, and local organisations make many buying decisions. Before inviting bids or selecting a route, establish who has authority to buy, whether a relevant framework can be used, whether a further competition is required, and what procurement rules apply to the contract. NHS England describes frameworks as agreements that can enable call-offs; a framework listing is a route to purchase, not proof that a product suits your service.
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NHS Supply Chain says that products must be procured through a compliant tender to be listed in its catalogue and, if successful, appear under a framework agreement. Buyers should confirm that a relevant agreement covers the product and their intended purchase, and follow its terms.
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Do not apply England-specific rules across the UK. The Provider Selection Regime (PSR) applies in England to specified healthcare-service procurement by relevant authorities. NHS England says it does not apply to procurement of goods or non-healthcare services unless they form part of a mixed procurement. If an IVD supply contract also includes a clinical service, establish which regime applies to the combined scope and obtain procurement advice from your organisation.
NHS England explains supplying to the NHS, and its PSR statutory guidance sets out the scope of that England regime.
7. Use an evidence checklist before making the decision
Tailor this checklist to the device, intended use, buyer and contract. It is a practical evaluation aid, not a universal legal document list.
- Exact device model, intended purpose and documentation relevant to the proposed market and conformity route.
- Performance evidence relevant to the service’s intended use.
- Current quality-system certificates, their scope and accreditation, and coverage of relevant supply-chain activities.
- Implementation, interface, training, validation and transition plans.
- Maintenance, support, response and escalation arrangements.
- Reagent and consumable availability, lead times, stock and contingency information.
- Transparent lifecycle pricing, including relevant post-warranty support costs.
- Evidence for each material clinical, operational, supply-chain and value claim used in the evaluation.
- Procurement route, applicable framework or tender terms, and any organisation-specific approval requirements.
A defensible choice is one that meets the defined service need, has appropriate device and supplier evidence, can be implemented and supported locally, and offers value under a lawful route for the buyer and contract. No single mark, certificate or catalogue entry can replace those separate checks.
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