ServicesClinical and performance evidence

Clinical and performance evidence strategy for medical devices and IVDs

Medical device regulation does not simply require “a clinical study”. The relevant question is what evidence is necessary to support this particular intended purpose, claims, patient population and regulatory pathway.

For medical devices this may involve clinical evaluation and, where necessary, clinical investigation. For IVDs it may involve scientific validity, analytical performance and clinical performance. Fabola helps manufacturers define the evidence strategy before unnecessary studies are commissioned.

Who this is for

  • Medical device manufacturers
  • IVD manufacturers
  • Medical device software and AI-enabled device developers
  • Companies preparing a clinical evaluation or performance evaluation
  • Startups planning product validation
  • Teams receiving questions about insufficient clinical or performance evidence

The problem it solves

Startups frequently either underestimate evidence requirements or collect significantly more data than the regulatory strategy requires. Both can be expensive. We help answer:

  • What claims need evidence?
  • What evidence already exists?
  • Can published literature contribute?
  • Is existing clinical or performance data sufficient?
  • Is a clinical investigation or performance study required?
  • What analytical and clinical performance needs to be demonstrated?
  • What endpoints should validation address?
  • Where are the current evidence gaps?

Required inputs

  • Intended purpose
  • Device or IVD description
  • Product claims
  • Target population
  • Clinical or laboratory workflow
  • Existing literature
  • Existing verification and validation data
  • Similar or comparable product information
  • Current clinical or performance evaluation documents, if available

What Fabola does

We map claim → regulatory requirement → evidence source → gap → required activity. The objective is a traceable evidence strategy rather than a collection of disconnected studies.

Deliverables

  • Clinical or performance evidence map
  • Evidence gap analysis
  • Literature strategy
  • Validation strategy
  • Recommended study types
  • Endpoint and acceptance-criterion recommendations
  • Evidence-generation roadmap
  • Input to CEP, CER, PEP or PER planning
  • Traceability between claims and evidence

Price

Focused evidence gap review

SEK 49,000

Review of existing evidence against intended purpose and claims, with a prioritised gap list.

Evidence strategy

SEK 69,000

Claims-to-evidence map, gap assessment and defined clinical or performance evidence roadmap for one main intended use.

Complex evidence strategy

SEK 89,000–99,000

Multiple claims, populations, evidence streams, IVD performance components or a materially complex evidence programme.

All prices are in SEK and exclude VAT.

Delivery time

Typical delivery: 2–4 weeks.

Completion point

The project is complete when the evidence requirements, existing evidence and remaining gaps have been mapped and a defined evidence-generation plan has been delivered.

Exclusions

  • Acting as a CRO
  • Recruiting study participants
  • Operating clinical investigation sites
  • Performing laboratory testing
  • Statistical programming or data-management execution unless separately agreed

If further work is needed

Depending on the outcome, no further Fabola work may be required. Where additional work is identified, common next steps include AI validation and evidence, development of a clinical or performance study protocol, or preparation of the relevant clinical or performance evaluation documentation.

Frequently asked questions

Do all medical devices need a clinical investigation?

No. The required clinical evidence depends on the device, intended purpose, risk, available evidence and the applicable MDR requirements. The evidence strategy determines whether existing evidence is sufficient or whether new clinical investigation data are needed.

What is different for IVDs?

The IVDR performance evaluation framework addresses scientific validity, analytical performance and clinical performance. The evidence strategy should show how these components support the intended purpose and performance claims.

Can you tell us whether our existing study is enough?

Yes. A focused evidence gap review can compare the existing study design and results with the intended purpose, claims and regulatory evidence needs.

Can this be done before a validation study starts?

Yes. That is often the most cost-effective timing because the regulatory question can shape endpoints, acceptance criteria, population selection and data collection before money is committed.

Primary regulatory sources

Last reviewed: September 2026

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Ready to define the work?

Tell us what the product is, where the project stands and the regulatory question you need answered.

We will confirm whether this service fits, or point you to a better starting point.

Discuss your evidence strategy

The first conversation is free and carries no commitment.