The combined products WG focuses on policy and regulatory issues specific to drug/device combinations, including integral drug/device combinations under art. 117 MDR, cross-labelled and co-packaged drug/device combinations. Its goal is to contribute to current discussion at EU level and to help shaping the regulatory landscape that is needed to ensure the timely market release of safe and innovative combined products.

The MPP definition of combined products is broader than the EU concept of “combination products” to better match the reality of products that combine drug and devices components. The MPP defines combined products as follows: “A combined product is any combined use of a medicinal product, including biologics and advanced therapy medicinal products (ATMPs), with a device or diagnostic for medical purposes, without forming necessarily an integrated unit covering also e-/m-health products. Combination products are a sub-group of combined products”.

The connected combined products WG focuses on policy and regulatory issues relevant to combined products that include software, mobile platform and/or a cloud application. Its goal is to contribute to ongoing regulatory and policy discussions with a view of ensuring the proportionate, adequate and safe regulation of connected combined products as well as to foster the integration of new technologies in innovative combined products.

The MPP defines connected combined products as follows: “A connected combined product (CCP) is considered 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”.