In vitro diagnostics conformity assessment and performance evaluation according to IVDR 2017/746

We support our clients to achieve conformity for their “in vitro diagnostic medical devices” (IVD) according to the IVD Regulation (EU) 2017/746 by

  • developing the right strategies for the IVD
  • getting prepared for IVDR conformity, and
  • perform activities for performance evaluation and clinical evidence covering the three pillars scientific validity, analytical performance, and clinical performance for the device before (reference: IVDR Chapter VI “Clinical evidence, performance evaluation and performance studies) and after market entry (reference: IVDR Chapter VII “Post-market surveillance, vigilance and market surveillance) in compliance to the IVDR

IVD(R)

Strategy

  • Development of intended purpose/intended use statements including intended patient population

 

  • Defining strategies to establish sufficient clinical evidence and performance for the device including analytical & clinical performance requirements according to the General Safety and Performance Requirements (GPSR)

 

  • Assessments of State of the Art (SOTA), scientific validity, clinical utility & medical risk for your IVD device

IVDR

Preparedness

  • Standard Operating Procedures (SOPs) for IVD performance evaluation (Annex XIII of the IVDR)

 

  • Evaluation and (gap) analysis of clinical evidence covering SOTA, scientific validity, analytical & clinical performance and assessment of benefit-risk ratio

 

  • Development of essential performance plans including Performance Evaluation Plan, Clinical Study Plan, Post-Market Follow-Up Plan

IVDR conformity

Performance Evaluation

  • Creation and review of essential performance documentation Performance Evaluation Plan, Scientific Validity Report, Analytical & Clinical Performance Report, Performance Evaluation Report, Summary of Safety and Performance

 

  • Systematic literature review comprising literature search methodology, protocol, appraisal and report

 

  • Planning and conducting clinical performance studies (retrospective/prospective studies)

 

  • Activities for Post-Market Surveillance (PMS) and Post-Market Performance/Clinical Follow-Up (PMPF, PMCF) including post market clinical registry trials, periodic updates of PMS and PMPF reports

The Therawis team, individually with more than 20 years professional experience, possesses a significant track record in IVDR evaluation, assessment and documentation with > 20 IVD products for our clients in the last 3 years. The team is composed of professionals in science, analytical & clinical development, medical & clinical affairs and quality assurance.