How long does a clinical performance study take?

From protocol to PER, a Class C study typically runs 6–9 months; Class D with Common Specifications panels and multicentric design typically runs 9–14 months. Site activation and ethics submission account for ~6–8 weeks of that.

Do you provide samples for Class D performance studies?

Yes — through Italian and EU clinical sites we coordinate prospective sampling at blood-donation centres and clinical departments, plus established residual-sample inventories and cross-reactive panels for specificity assessment under IRB exemption.

How many sites are typically needed for a multicentric study?

Class D bloodborne pathogens typically need 3–5 sites to satisfy EU Common Specifications 2022/1107 and statistical power. Lower-class devices may run at 1–2 sites depending on intended purpose and sample-size justification.

Can you run IEC 62366 usability studies for self-tests?

Yes — both formative and summative usability per IEC 62366, with lay-user recruitment. PT-INR self-test under ISO 17593 is in scope as well.

Are studies run under GCP or ISO 20916?

IVD performance studies follow ISO 20916:2019 (the IVD analogue of GCP). Where the device interacts with patient management decisions, we additionally apply GCP-style monitoring and source-data verification.

IVD performance evaluation & CRO studies.

Most consultancies stop at writing the performance evaluation documents. We do not. FirsTeckBio designs the protocol, finds the sites, submits to ethics committees, monitors the study, manages the data, runs the statistics and writes the reports — turning IVDR Annex XIII requirements into evidence a notified body can actually review. Anchored in ISO 20916:2019, IEC 62366 and EU Common Specifications 2022/1107.

The FirsTeckBio IVDR Evidence Pathway

A 5-step model for taking an IVD device from regulatory question to submission-ready evidence package — the lens through which the rest of this page is organised.

1. Regulatory question: Intended purpose, classification (Class A/B/C/D), self-test vs. professional, applicable Common Specifications — what evidence does this device actually need?
2. Evidence strategy: Gap against existing data, scientific validity coverage, analytical gaps, clinical performance design, sample plan, multicentric vs. single-site.
3. Study execution: Protocol, site selection, ethics submission, monitoring, data collection, statistics — the operational core most consultancies do not deliver.
4. Documentation: SVR, APR, CPR, PER, PEP, CPSP, CPSR aligned with intended purpose, technical documentation and notified-body review logic.
5. Post-market evidence loop: PMS plan, PMPF protocols, vigilance interface — closing the IVDR evidence cycle and feeding new data back into the technical documentation.

Scientific Validity

Establishing the link between your analyte and the clinical condition — the first pillar of IVDR Annex XIII.

Literature review & SOTA: Systematic literature search, state-of-the-art mapping, identification of clinical association, peer-reviewed evidence and consensus documents.
KOL & expert consultation: Engagement with clinical and laboratory experts in the relevant disease area for clinical-association validation.
Scientific Validity Report (SVR): Integrated SVR documenting the scientific basis for the intended purpose, ready for inclusion in the Performance Evaluation Report.

Analytical Performance

Quantifying what the device measures and how well — the second pillar of IVDR Annex XIII.

Precision & accuracy: Repeatability, reproducibility, total precision per CLSI EP05; trueness and bias studies.
LoB / LoD / LoQ: Limits of blank, detection and quantitation per CLSI EP17 — critical for low-positive specificity in Class D devices.
Method comparison: Method-comparison studies per CLSI EP09 against the relevant predicate or reference device.
Matrix equivalence: Matrix-equivalence studies per CLSI EP35 — serum vs. plasma, capillary vs. venous, fresh vs. frozen.
Cross-reactivity & interference: Specificity panels, cross-reacting samples and interfering-substance studies under Common Specifications.
Stability: Open-vial, shipping, in-use and shelf-life stability supporting the labelled claim.

Clinical Performance

Demonstrating the device performs in the target population — the third and heaviest pillar of IVDR Annex XIII.

Study design under ISO 20916: Clinical performance study design per ISO 20916:2019 with appropriate endpoints, sample size, statistical plan and bias control.
Site selection & feasibility: Italian and EU hospital, private laboratory and blood-donation centre site selection and feasibility assessment.
Ethics & competent authority: Submissions to ethics committees and, where required, national competent authorities under IVDR Annex XIV / national law.
Endpoints & statistics: Pre-specified primary and secondary endpoints, sample-size justification, and a statistical analysis plan that survives notified-body scrutiny.
Diagnostic accuracy: Sensitivity, specificity, PPV/NPV, ROC analysis — with confidence intervals appropriate to the device class.
Clinical Performance Report (CPR): The CPR integrating prospective and retrospective data into a single IVDR-compliant deliverable.

Usability Studies (IEC 62366)

When the user is a lay person, usability becomes part of performance — required for self-tests and many near-patient devices.

Formative & summative: Formative usability for design iteration and summative usability for IVDR submission, per IEC 62366.
Lay-user studies: Recruitment of representative lay-user populations for self-test and near-patient devices (e.g. PT-INR self-test under ISO 17593).
Use-error analysis: Identification, classification and risk-assessment of use errors with mitigation tracing to risk management (ISO 14971).

Study Operations

The CRO execution layer most consultancies cannot offer. This is where studies actually happen.

Protocol & investigator brochure: ICH-style study protocol, investigator brochure, informed consent and case report forms.
Project management: Dedicated project manager, study timelines, risk log and a single point of contact for the sponsor.
Monitoring: On-site and remote monitoring with source data verification, protocol deviation tracking and site-quality oversight.
Data management: eCRF setup, data validation, query management, database lock — to GCP-style standards adapted for IVD studies.
Biostatistics: Statistical analysis plan, interim analyses where appropriate, final analysis with tables, listings and figures (TLFs).
Pharmacovigilance interface: Adverse-event and device-deficiency reporting in line with IVDR vigilance expectations.

Reporting & Documentation

Submission-ready deliverables aligned with notified-body expectations — not lab data thrown over a wall.

PEP — Performance Evaluation Plan: Annex XIII Section 1 PEP linking scientific validity, analytical and clinical performance into one strategy.
APR — Analytical Performance Report: Consolidated analytical performance evidence with traceable links to underlying study data.
CPR — Clinical Performance Report: Clinical performance results, statistical analysis and discussion of the intended-purpose claim.
PER — Performance Evaluation Report: The top-level IVDR Annex XIII deliverable integrating SVR, APR, CPR into one report.
CPSP & CPSR: Clinical Performance Study Protocol and Report, when a dedicated IVDR Annex XIII Section 2 study is conducted.
Posters & publications: Where appropriate, performance data converted into peer-reviewed posters and publications — see our Euromedlab 2025 and Elas National Congress 2025 contributions.

Plan your IVDR performance evaluation

Share your device, intended purpose and current evidence base. We will scope the scientific validity, analytical, clinical and usability work — and the study sites — for your specific case.

Discuss your performance study