Module 19 2021

02/06/2021

Intended medical purpose

Now For the quantitative measurement of rhubarb in human serum on the SL+ instrument. For use in people with specific symptoms to help identify those with stage III rhubarb disease. Only for use by qualified laboratory professionals.

Previously For the measurement of serum rhubarb

Performance Evaluation Report

Analytical performance report

Clinical performance report Clinical performanc e studies Peer

Scientific validity report

Other device

Specimen type

Classification

IVDD risk categories

Examples

IVDR risk classification

Examples

Literature review

Annex II List A

ABO blood groups; HIV infections;

Class D ABO blood groups; HIV infections; Emergency epidemics

Accuracy

reviewed literature Published experience

Annex II List B

Blood glucose self tests PSA PKU Rubella, toxoplasmosis, CMV, chlamydia

Class C

Tests for cancer ; Tests for sexually

Sensitivity/ specificity Measuring range/ cut- off Novel markers

Expert opinion

transmitted infections ; Companion diagnostics; Human genetic tests; Most devices for self- testing Pregnancy self-tests; Cholesterol tests; Urine test strips;

Equivalence ?

Studies

Self testing Devices for self testing

Class B

General

Tests for cancer; Tests for sexually

Class A Clinical chemistry analyser;

transmitted infections; Companion diagnostics; Human genetic tests;

Specimen receptacles;

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https://ec.europa.eu/health/md_sector/contact_en

https://ec.europa.eu/health/md_sector/new_regulations_en

https://ec.europa.eu/health/md_sector/new_regulations/guidance_en

https://ec.europa.eu/docsroom/documents?locale=en&keywords=medical%20device

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