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Choose an in vitro diagnostic (IVD) supplier by starting with the service your laboratory needs, then checking the exact device’s regulatory status, the supplier and supply chain, clinical and operational fit, whole-life cost, and the procurement route your organisation can use. No mark, certificate or framework listing by itself proves that a device is suitable for your service.
1. Define the service requirement before comparing suppliers
Write a requirement that describes what the service must do before inviting proposals or scoring suppliers. The intended setting and use determine which tests, performance evidence, workflow and support matter. The MHRA’s IVD procurement guidance is aimed at staff who purchase, supply, use, maintain and replace IVDs; it was last updated on 28 January 2021. Use it alongside newer regulatory guidance when checking current requirements.
- Service and intended use: specify the patient population, testing location, clinical purpose, test menu and whether tests are routine, urgent or point-of-care.
- Demand and capacity: estimate test volumes, peaks, operating hours, required turnaround and the capacity needed during service disruption.
- Performance: identify the analytical and clinical performance requirements relevant to the proposed use, and what evidence your clinical and laboratory teams need to assess them.
- Workflow and interfaces: document sample handling, staffing, space, utilities, laboratory information-system or other data interfaces, result reporting and any downstream processes.
- Implementation and support: set expectations for installation, validation or verification as appropriate to the service, staff training, maintenance, response times, escalation and continuity arrangements.
- Supply and cost: identify reagent and consumable needs, availability expectations, stock and lead-time information, and the pricing detail required to assess whole-life cost.
These are planning prompts, not a universal legal document list or a substitute for local clinical, technical, information-governance and procurement requirements. Tailor the specification to the discipline, site, service model and risk.
2. Verify the exact device and the market where it will be used
Ask bidders to identify the precise device model and intended purpose they are proposing. Check the conformity route, supporting documentation and any registration requirements applicable to that device’s classification, intended use and destination market. Do not assume that every IVD follows the same route.
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The 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 current requirements for the specific device rather than relying on a general supplier statement.
Great Britain and Northern Ireland do not have identical marking rules. The MHRA’s conformity-assessment and UKCA guidance, last updated on 13 May 2026, explains that the conformity route depends on classification. It says 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; CE marking continues to be needed there under the rules described in that guidance. Because market-access and transitional arrangements can change, verify the current route directly before award or purchase.
Regulatory documentation is not a substitute for clinical suitability. Check that the stated intended purpose and available performance evidence support the use your service proposes. A conformity mark does not, on its own, establish that the test performs adequately in your local population, workflow or clinical pathway.
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3. Assess the supplier, quality evidence and supply chain
Establish who manufactures the device, who will contract with and support your organisation, and which parties handle storage, distribution, servicing and escalation. Request current quality-system evidence and inspect its scope, validity, accreditation and relevance to the organisations and activities in the proposed supply chain.
ISO 13485 covers medical-device manufacturers’ quality-management systems, but certification is not product authorisation or proof of diagnostic performance. Requirements also depend on the buyer and contract. For participation in its relevant framework agreements, NHS Supply Chain’s supplier 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 declarations of conformity, MHRA registration and applicable conformity-assessment routes. Treat these as requirements stated for that NHS Supply Chain context, not as a blanket legal rule for every buyer.
For your own tender, check the applicable specification and ask for evidence that matches the proposed arrangement. A certificate covering one company or activity may not establish assurance over another manufacturer, distributor, storage site or service provider in the chain.
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4. Compare proposals against the same evidence-based criteria
Use the same requirements and questions for each bidder, and agree how evidence will be evaluated before scoring. The national value-based procurement guidance published on 11 June 2026 by DHSC in partnership with 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. It advises buyers to choose relevant questions proportionately to the cost, nature and complexity of the procurement, and to validate clinical and financial claims with appropriate local teams.
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|---|---|
| Purpose | Does the device’s intended purpose and performance evidence fit the service requirement? Are the proposed test menu, capacity and workflow appropriate to the stated use? |
| Patient and staff | What are the relevant effects on patients and staff in this setting, including workflow, training and the way results enter care? Ask the clinical team to assess claims against local practice. |
| Efficiency | What changes to process, staffing, turnaround or resource use does the bidder propose, and what evidence supports those claims? Do not treat projected benefits as established outcomes without validation. |
| Supply chain | What are the arrangements for stock, lead times, supply diversity, contingency stocks, alternative manufacturing and access to contingency supplies? Request information specific enough to assess the service’s exposure. |
| Social value | What social-value commitments are relevant to the procurement, and how will the buyer assess and monitor them under its tender? |
| Whole-life cost | What is the purchase cost and what relevant post-warranty support costs apply? Request transparent lifecycle pricing for the proposed configuration and service so finance and clinical teams can assess it consistently. |
The domains reflect the national guidance’s value-based approach. Select the questions and any scoring method to suit the procurement; there is no universal weighting in the cited guidance that should be imposed on every IVD purchase.
5. Check implementation, support and resilience in practical terms
Ask suppliers to describe how the proposed system will work at your site, not just what it can do in principle. Compare concrete plans and service commitments, and involve the people who will run, maintain and rely on the service.
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- Implementation: request a timeline, site requirements, responsibilities, dependencies, interface work and the proposed approach to staff training and service transition.
- Technical support: clarify maintenance arrangements, response and escalation processes, service coverage and what happens when the device is unavailable.
- Consumables: ask about reagent and consumable availability, lead times, stock coverage and how the supplier will communicate a shortage.
- Resilience: request information on inventory, contingency stock, supply diversity, alternative manufacturing arrangements and expected access to contingency supplies. Set local thresholds based on the service’s risk rather than accepting a general assurance.
- Data and interfaces: establish which integrations are included, who is responsible for them, what information is exchanged, and how support is handled when a connection or data flow fails.
Use the same assumptions when comparing implementation promises and support costs. A low purchase price may not represent the lowest whole-life cost if relevant post-warranty support or other required parts of the proposed service are priced separately.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.6. Establish the lawful purchasing route for your organisation
There is no single procurement route that applies to every UK laboratory or healthcare provider. NHS purchasing takes place at different levels, and local organisations make many buying decisions. NHS England’s supplier information describes frameworks as agreements that can enable call-offs. Confirm whether your organisation can use a relevant framework, needs to run a competition, or must follow another applicable route.
For NHS Supply Chain catalogue products, NHS Supply Chain explains that products must be procured through a compliant tender to be listed in its catalogue and, if successful, appear under a framework agreement. A catalogue or framework listing describes a procurement route; it does not by itself show that the device is the right clinical and operational fit for your service.
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Do not confuse the Provider Selection Regime with a general route for buying IVD goods. The NHS England statutory guidance on the Provider Selection Regime says the England regime applies to specified healthcare-service procurement by relevant authorities, not procurement of goods or non-healthcare services unless part of a mixed procurement. If a device supply contract also includes a clinical service, establish which regime applies and seek your organisation’s procurement advice. England-specific rules should not be assumed to apply across the whole UK; check the requirements relevant to the buyer’s nation and contract.
7. Make the decision traceable
Record the requirement, the evidence reviewed, the rationale for scores, material risks and any conditions to resolve before implementation. Keep regulatory status, supplier assurance, clinical suitability, operational fit and commercial value as distinct parts of the decision. A defensible choice is the proposal that meets the service need, is supported by relevant evidence and can be bought through the organisation’s applicable route—not simply the one with the most familiar mark, certificate or framework status.
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