Choose an in vitro diagnostic (IVD) supplier by first defining the service you need, then checking the exact device’s regulatory status and clinical fit, assessing the supplier and supply chain, and comparing whole-life value. No conformity mark, quality certificate or framework listing alone proves that a particular IVD is suitable for your service.
The right procurement and regulatory checks depend on the device, intended use, UK nation, buyer and contract scope. Use the steps below as a decision framework, then confirm the current requirements that apply to your procurement.
1. Define the service requirement before approaching suppliers
Start with the testing service, not a preferred analyser or supplier. A clear requirement lets bidders respond to the same need and helps your clinical, laboratory, procurement and finance teams assess proposals consistently. MHRA’s procurement guidance is aimed at staff who purchase, supply, use, maintain and replace IVDs; it was last updated on 28 January 2021, so use it alongside the newer regulatory guidance linked below.
- Intended use and setting: specify the patient group, testing purpose, where testing will take place and who will perform it. Include whether the requirement is for a laboratory service or point-of-care testing.
- Test menu and workload: identify the required tests and expected volumes, including relevant patterns in demand. State any capacity, turnaround or operating-hour requirements that matter to the service.
- Clinical and performance needs: describe the performance evidence and other clinical requirements relevant to the proposed use. Have the appropriate clinical and laboratory teams define how claims will be assessed.
- Workflow and interfaces: document space, utilities, sample handling, staffing, information-system interfaces, data and connectivity requirements, and any workflow changes the solution would require.
- Implementation and support: specify installation, validation or verification activities as applicable, staff training, maintenance, response and escalation arrangements, and the service support needed locally.
- Supply and cost: set out reagent and consumable needs, supply continuity expectations, and how you will compare purchase, operating and relevant post-warranty support costs.
Turn these needs into a specification and a common set of questions for all bidders. Tailor the level of detail to the cost, nature, complexity and risk of the procurement rather than treating this list as a universal legal document checklist.
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2. Verify the exact IVD and its market route
Check the exact model, manufacturer, intended purpose and proposed market—not just the supplier’s product family or a general statement that a product is “approved.” The conformity route and documentation depend on the device’s classification and intended use.
MHRA’s IVD legislation guidance, last updated on 15 January 2025, describes controls for IVDs placed on the Great Britain market under Part IV of the UK Medical Devices Regulations 2002, as amended. It covers scope, assessment and in-house manufacture. Confirm the route and applicable documentation for the specific device rather than assuming every IVD follows the same pathway.
Great Britain and Northern Ireland do not have identical marking rules. MHRA’s conformity assessment and UKCA guidance, last updated on 13 May 2026, explains that the route depends on classification, says UKCA marking is used in Great Britain, and says a UKCA mark alone is not sufficient to place a medical device on the Northern Ireland market; CE marking continues to be needed there under the rules described in that guidance. Because market-access and transitional arrangements can change, check the current MHRA requirements for the precise device and location at the time of procurement.
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Request the device-specific declarations, certificates and registration information applicable to its route, and check that names, model identifiers, intended purpose and market align. A supplier’s quality-system certificate is a separate check: MHRA identifies ISO 13485 as a standard for medical-device manufacturers’ quality-management systems and notes that use of designated standards is optional. ISO 13485 certification does not itself establish product authorization or diagnostic performance.
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Establish who makes the device, who will supply and support it, and which organisations handle storage, distribution, maintenance and service. Examine current quality-system evidence, including its scope, issuing or accreditation body, validity and the activities and entities it actually covers. A certificate is useful only to the extent that it applies to the relevant part of the supply chain and the proposed work.
NHS Supply Chain sets specific requirements for suppliers seeking to participate in its relevant framework agreements. Its contract and tender process information calls for 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. It also describes declaration-of-conformity, MHRA-registration and applicable conformity-assessment requirements. These are requirements in that NHS Supply Chain context, not a blanket legal rule for every buyer or every procurement.
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For any route, ask bidders to identify the responsible manufacturer and supply-chain parties, provide the relevant current certificates and explain any gaps in coverage. Confirm who is accountable for implementation, training, maintenance, technical support and escalation after the contract starts.
4. Compare clinical fit, operational value and whole-life cost
Score proposals against the same requirements. The national value-based procurement guidance, published on 11 June 2026 by the Department of Health and Social Care (DHSC), NHS England and NHS Supply Chain, includes IVDs and point-of-care testing. It is a quality-assessment framework for specifying requirements and evaluating tenders, not an end-to-end procurement procedure. Its five domains provide a useful structure for comparing offers:
| Domain | What to assess for an IVD proposal | Evidence or questions to request |
|---|---|---|
| Purpose | Whether the device’s intended purpose and performance evidence fit the service’s clinical need and proposed use. | Exact model and intended-purpose documentation; relevant performance evidence; explanation of how the proposed use aligns with the requirement. |
| Patient and staff | Effects on patients and the people who operate, interpret, maintain or support the testing service. | Evidence relevant to the specified patient and staff needs; training arrangements; workflow and usability considerations relevant to the setting. |
| Efficiency | How the solution would work within the local workflow and what it requires to implement and operate. | Implementation plan; staffing, interface and data requirements; maintenance and response arrangements; costs over the relevant lifecycle. |
| Supply chain | Whether devices, reagents, consumables and support can be supplied reliably, including during disruption. | Inventory and stock coverage information, lead times, contingency stocks, supply diversity, alternative manufacturing arrangements and expected access to contingency stock. |
| Social value | Social-value outcomes relevant to the procurement and the buyer’s specification. | Ask bidders for evidence against the social-value requirements chosen for this procurement; define those requirements in the tender. |
For the financial comparison, include the purchase price and relevant post-warranty support costs, alongside other lifecycle costs that apply to the proposed service. Make the assumptions visible—for example, what is included in installation, training, maintenance, software or interfaces, and consumables—so that a lower headline price is not mistaken for lower total cost. The national guidance advises buyers to select questions proportionately to the procurement’s cost, nature and complexity and to involve clinical and finance teams in validating claims. Do not use a universal score weighting: set criteria and weights to fit the procurement and its applicable rules.
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Use the same evidence standard for each bidder. Where a claim affects clinical suitability, cost or service continuity, ask for support that your relevant local team can validate rather than relying on an unqualified assurance.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.5. Select the procurement route that applies to your buyer and contract
There is no single NHS buying route for every IVD. NHS purchasing takes place at different levels, and local organisations make many purchasing decisions. NHS England’s information on supplying to the NHS describes frameworks as agreements that can enable call-offs. Establish whether your organisation can use a relevant framework, must run a competition, or needs another lawful route; check the applicable rules and tender terms for your organisation and contract.
NHS Supply Chain says products must be procured through a compliant tender to be listed in its catalogue and, if successful, appear under a framework agreement. A catalogue listing or framework award is evidence of that route’s procurement status; it does not replace your assessment of the IVD’s fit for your service or the checks required for your own purchase.
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Keep England-specific healthcare-service rules distinct from goods procurement. The Provider Selection Regime (PSR) applies in England to specified healthcare-service procurement by relevant authorities. NHS England’s PSR statutory guidance says it does not apply to procurement of goods or non-healthcare services unless they form part of a mixed procurement. If a device-supply contract also includes a clinical service, determine which regime applies to the overall contract and obtain procurement advice from the buyer’s appropriate team. Do not extend England-specific rules to the whole UK.
6. Make the decision and document the rationale
Before award, record how each proposal meets the requirement, what evidence supports the assessment, how lifecycle costs were compared, and why the chosen procurement route applies. Document any material assumptions, risks, conditions or unresolved points and who is responsible for resolving them. This creates a decision that can be reviewed against the service need rather than resting on a brand, certificate, mark or catalogue entry alone.
For a practical tender or quotation pack, tailor requests for the following evidence to the device, procurement and applicable rules:
- Exact device model, intended-purpose documentation, applicable declarations and certificates, and market registration or conformity-route information.
- Performance evidence relevant to the proposed use and the bidder’s explanation of how it meets the specified clinical needs.
- Current quality-system certificates, their scope and accreditation, and identification of the manufacturer, distributor and relevant supply-chain responsibilities.
- Implementation, training, interface, data, maintenance, response and escalation plans for the local setting.
- Reagent and consumable availability, inventory or stock coverage, lead times, contingency arrangements and other supply-resilience information.
- Transparent pricing that identifies purchase and relevant post-warranty support costs, with assumptions and included services clearly stated.
The 2026 national value-based procurement guidance is available at Value based procurement: national standard guidance for medical technology. Check the linked MHRA and procurement guidance again when making a decision, since regulatory routes and procurement requirements can change.
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