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Combines health technologies

Combining pharma, medtech and tech to bring innovation to the patients

DEFINITION OF COMBINED HEALTH TECHNOLOGIES

The application of innovation to support disease understanding and therapy management leads to the increasing combined use of health technologies to:

  • Improve patient’s quality of life, health and adherence to treatment
  • Support the development of personalized and home-based medicine
  • Help healthcare professionals achieve more efficient workflow and higher quality therapy insights, leading to reduced healthcare spending

MPP refers to these combined health technologies as “combined products”, which refer to the combined use of a medicinal product with a device or diagnostic and/or e-/m-health products for a medical purpose, without necessarily forming an integrated unit.

The increasing use of digital technologies leads to the development of what we refer to as “connected combined products”, defined by the MPP as the combined use of a medicinal product with two or more of the following products: (delivery) device, in vitro diagnostic (IVD), standalone software, mobile platform, and/or a cloud application with the aim to deliver a medicinal product to patients and/or to monitor certain data and parameters, such as medical adherence.

COMBINATION OF HEALTH TECHNOLOGIES

The combination of health technologies that fall under the MPP Association’s definition of combined products can take various forms. They are used by healthcare professionals on an everyday basis to treat many different conditions. A few types of combined products are listed here as examples:

    Integral drug/device combination for single or multiple use

    e.g. prefilled syringe, re-usable autoinjectors, transdermal patches, contact lenses coated with a drug, drug eluting stents

    Integral drug/device combination for single or multiple use

    e.g. prefilled syringe, re-usable autoinjectors, transdermal patches, contact lenses coated with a drug, drug eluting stents

    Medicinal products and medical devices packaged together for combined use (co-packed combined products)

    e.g. vaccine packed with a delivery device

    Medicinal products and medical devices packaged together for combined use (co-packed combined products)

    e.g. vaccine packed with a delivery device

    Medicinal products and medical devices packaged separately but intended for combined used (cross-labelled combined products)

    e.g. photosensitizing medicinal product and activating laser

    Medicinal products and medical devices packaged separately but intended for combined used (cross-labelled combined products)

    e.g. photosensitizing medicinal product and activating laser

    Drug/device combination used with a digital technology (connected combined products)

    e.g. insulin pump monitored by an application

    Drug/device combination used with a digital technology (connected combined products)

    e.g. insulin pump monitored by an application

    CURRENT REGULATORY FRAMEWORK FOR COMBINED PRODUCTS

    In the European Union, there is no unique framework for combined products. As a result, they are regulated under different frameworks, including:

    • Medicinal products: Medicinal Products Directive (MPD)
    • Medical devices: Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR)
    • Data and digital, e.g. General Data Protection Regulation (GDPR) and the upcoming AI Act

    Depending on their structure and components, combined products are regulated as medicinal products or medical devices, triggering the application of different requirements and procedures.

    The MPP aims to bridge the gap between the coexisting legislative frameworks in order to achieve a balanced framework for combined products.