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In Vitro Diagnostic Regulation (IVDR) Services

The therawis team, individually with more than 20 years professional experience, possesses a significant track record in In Vitro Diagnostic (IVD) medical device performance evaluation, conformity assessment, and documentation for >30 IVD products from our clients in the last 5 years in compliance with the REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT ANDOF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices(IVDR 2017/746).

The IVDR team is composed of professionals in science, analytical & clinical development, medical & clinical affairs and quality assurance.

In compliance to the EU-IVDR 2017/746, the team supports our clients to

develop the optimal IVDR strategy for your IVD

prepare for IVDR conformity

perform activities and write key documents for performance evaluation and clinical evidence covering the three pillars scientific validity, analytical performance, and clinical performance for the device before and after market entry (reference: chapter VI “Clinical evidence, performance evaluation and performance studies” and chapter VII“Post-market surveillance, vigilance and market surveillance”) and in compliance to the EU-IVDR 2017/746 Annexes I, II, III, XIII, and XIV.

Overview

IVD(R) Strategy

Develop & assess intended purpose/intended use statements including intended patient population

Define strategy to establish clinical evidence and performance for the device including analytical & clinical performance requirements according to the “General Safety and Performance Requirements” (GPSR 1-20, Annex I of the EU-IVDR 2017/746)

Assess State of the Art (SOTA), Scientific Validity, Clinical Utility & Medical Risk for your IVD device (compliant to Annex I, II, III, XIII and XIV of the EU-IVDR 2017/746)

IVDR Preparedness

Establish Standard Operating Procedures (SOPs) for IVD performance evaluation (related to Annex XIII and XIV of the EU-IVDR 2017/746)

Perform gap analysis of clinical evidence covering SOTA, scientific validity, analytical & clinical performance and of benefit-risk ratio (compliant to Annex I, XIII, XIV of the EU-IVDR 2017/746)

Develop essential performance plans including Performance Evaluation Plan, Clinical Study Plan, and Post-Market Follow-Up Plan (compliant to Annex XIII of the EU-IVDR 2017/746)

IVDR Conformity & Performance Evaluation

Create and review essential performance documentation such as Performance Evaluation Plan & Report, Scientific Validity Report, Analytical & Clinical Performance Plan & Report, State-of-the-Art (SOTA) Report, Summary of Safety and Performance (compliant to ANNEX XIII of the EU-IVDR 2017/746)

Perform systematic literature review comprising literature search methodology, protocol, appraisal and report (compliant to ANNEX XIII of the EU-IVDR 2017/746)

Plan and conduct clinical performance studies (retrospective/prospective studies) (compliant to Annex XIII and XIV of the EU-IVDR 2017/746)

Conduct Post-Market Surveillance (PMS) and Post-Market Performance/Clinical Follow-Up (PMPF, PMCF) activities including post market clinical registry trials, periodic updates of PMS and PMPF reports (compliant to Annex III, XIII and XIV of the EU-IVDR 2017/746)

For more information please see our brochures:

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IVDR Services

In Vitro Diagnostic Regulation (IVDR) Services