The MPP working groups
The MPP working groups (WGs) constitute a driving force for the association. They are at the core of the MPP’s policy and regulatory work and contribute to define the Association’s stance and input to European developments.
Currently, MPP has two WGs that meet regularly throughout the year. In these WGs, experts from MPP member companies discuss and find concrete solutions to challenges affecting combined products. WGs are driven by their members, who shape priorities and contribute to their strategies and various deliverables or outcomes.
Combined products working group
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”.
Connected combined products working group
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”.
Best Practice Guide
MPP Best Practice Guide for clinical trials with integral Drug-Device Combination Products including change control and usability studies
Reflection paper on regulatory uncertainties for co-packaged and cross-labelled drug-device combinations under the new Medical Device Regulation
Position paper on the legislative framework for Connected Combined Products