Question 1

Module 1: Analysis of Medical Devices And IVD Medical Devices Market Potential (Market Size, Market Trends, Infrastructure Mapping, Patient Flow)

Accepted Answer

Facilitates a comprehensive analysis of the medical devices and IVD medical devices market. Covering market potential, trends, infrastructure mapping, and patient flow. The application provides insights into the volume and monthly dynamics of patients undergoing clinical procedures, market dynamics by classes and reimbursement and more.

Question 2

Module 2: Analysis of Competition in the Medical Devices and IVD Medical Devices Market (Market Share, Market Participants, Competition)

Accepted Answer

Analysis of competition in the medical devices and in IVD medical devices market, focusing on market share, companies-market participants, and competition dynamics. It includes the volume of medical devices used in specific procedures, a comparative price analysis based on various criteria and more.

Question 3

Module 3: Value-based Application of Medical Devices and IVD Medical Devices (Value-Based Analysis: Cost-Effectiveness and Cost-Benefit)

Accepted Answer

A detailed budget impact analysis and cost-effectiveness/cost-benefit ratios. It includes a post marketing study for real-world outcomes and a comparative analysis of device deficiencies and risks as per EU Regulations 2017/745 and 2017/746.

Question 4

Module 4: Medical Devices and IVD Medical Devices Мarket Forecast

Accepted Answer

Anticipate a five-year forecast of the budget impact, potential market share, and the number of applicable medical devices based on expected patient numbers and incidence rates. The forecast also explores the impact on patient outcomes or public health, with a focus on monitoring the clinical effects of medical devices.

Question 5

Module 5: Clinical Trial Data Analysis

Accepted Answer

An examination of the methodology, design, and clinical evidence within the scope of EU Regulations 2017/745 and 2017/746. We will also analyze safety and effectiveness data from clinical trials and comparable studies, along with insights gathered from scientific literature reports.

Question 6

Module 6: Data analysis of indicators for tracking the effect of medical devices

Accepted Answer

Monitoring the effect of the medical device and medical device for in vitro diagnostics according to criteria/indicators previously set by the distribitors/manufacture, according to which monitoring and assessment of the condition of patients will be carried out, in which the new activities and/or medical devices proposed by the contracting authority are applied.

Question 7

Module 7: Medical devices and IVD Medical devices: regulatory status

Accepted Answer

• Horizon scanning of new medical devices and IVD medical devices, based on EU and local regulatory status.  
 • Provides information, prognosis and analysis of newly registered,  upcoming and/or innovative medical devices and IVD medical devices,  according to classification as per MDR and IVDR, listed as per  manufacturer and trade name and other variables.

Question 8

Module 8: Medical Devices and IVD Medical Devices: Quantities and Availability of reimbursed products

Accepted Answer

• The COVID-19 pandemic has highlighted the critical need for health  systems to be prepared for cross-border crises that threaten public  health.  
 • Ensuring predictability and availability of essential  medical devices and IVDs, especially those with reimbursed status, is  critical. This module provides local data on available quantities based  on the number of patients approved by the NHIF and requiring specific  medical devices and IVDs by trade name on an annual basis, as well as on  a monthly basis, according to the amount of reimbursed medical devices  and IVDs consumed by the number of patients, health establishments ICD,  clinical pathway, ambulatory procedure and in the outpatient care,  integrated with Module 1.

Modules