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

Likely next step

Typical next steps are an AI Validation & Evidence assignment, 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

Other services

Classification and conformity pathway

Is my product a medical device or IVD, what class is it, and what do I need to do to place it on the EU market?

MDR and IVDR readiness

How far are we from being ready for CE marking under the MDR or IVDR?

AI validation and evidence

How do we demonstrate that our AI-enabled medical device works reliably and safely for its intended medical use?

EU AI Act + MDR / IVDR

How does the EU AI Act interact with the MDR or IVDR for our product?

Notified Body readiness

Are we ready to submit to a Notified Body?

Regulatory intelligence

We have one defined regulatory question. Can you answer it without turning it into a six-month consulting project?

PRRC

Do we need a Person Responsible for Regulatory Compliance, and can Fabola fulfil that role?

What are you building?

Whether you have an idea, a prototype, a working product, a validation study underway or a Notified Body submission approaching, we can start with the decision you need to make now.

You do not need to know which regulatory service to ask for.

Talk to Fabola

Send us a short description of your product.