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Nagu telefoni teel sai räägitud, saadan linki piiripealsete seadmete manuaalile, kus on meditsiinilisi kalkulaatoreid selgitav sissekanne:  https://health.ec.europa.eu/system/files/2022-12/md_borderline_manual_12-2022_en.pdf

1.1.9.2 Medical calculators Background:

The intended purpose of a medical calculator is to facilitate one or more (sometimes up to 400) routine medical calculations at the point of care for multiple clinical disciplines by means of an app or webpage. Calculation methods incorporated in the medical calculator are taken from or based on formulas or tables documented in research publications and (national) guidelines. Often, these calculations are relatively simple and could be done with a basic electronic calculator or even on paper 13 (simple search). The healthcare professional enters several patient-specific variables after which the app calculates outcomes like risk scores, severity indexes, threshold values and other prognostic outcomes, depending on the specific calculation. The healthcare professional that uses the medical calculator at the point of care is likely to use the outcome of the calculation in making decisions about diagnosis or treatment of a patient in a routine setting.

Two examples of such medical calculations offered by this medical calculator are:

- calculation of stroke risk for patients with atrial fibrillation using the CHA₂DS₂-VASc Score to determine if patients need antithrombotic therapy (e.g. by prescribing anticoagulant medicine).

- calculation of the creatinine clearance using the Cockcroft-Gault Equation to determine the status of the kidney function. The calculated score is used to identify kidney failure and to help decide if dialysis is required.

Outcome Calculation of a score according to a specific formula or an complex algorithm as mentioned in both examples is an action on data beyond the use of simple search as referenced in qualification decision step 3 of MDCG 2019-11 (“Decision steps for qualification of software as MDSW”).

Also, the calculation is for the benefit of individual patients, as it does not only provide generic diagnostic or treatment pathways per decision step 4 of guidance MDCG 2019-11.

The presented device meets the definition of a medical device as it is intended by the manufacturer to be used for medical purposes in accordance with Regulation (EU) 2017/745.

Classification rule 11 applies, since it relates to software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes, and classifies this product as at least class IIa. A higher classification may apply depending on the significance of the information provided by the device to support the healthcare professional’s decision in the context of the patient’s condition, as per guidance MDCG 2019-11 and MDCG 2021-24.

Lisasin kirja koopiasse kolleegi Egle Audova, kes on tore inimene ja tegeleb ka klassifitseerimise ja piiripealsete seadmetega.

Lisaküsimuste korral palun pöörduge meie poole.