IVDR Services

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.