Basel, 22 October 2020
The Medtech & Pharma Platform (MPP) Association and its Working Group on Connected Combined Products (CCPs) are pleased to announce the “Position paper on the legislative framework for Connected Combined Products in the European Union”. The working group is made up of expert representatives from MPP members companies Philips Innovation Services, Novartis, Sanofi, SFL Regulatory Affairs & Scientific Communication, Swiss Medtech, Ypsomed, Anteris Helvetica, Merck, Sharp and Dohme, Aquilon Pharmaceuticals, Edwards Lifesciences, Covance, and Boehringer-Ingelheim.
This position paper proposes for the first time a definition for CCPs and provides various examples of CCPs that include medicinal product, delivery device, software as medical device for a medical purpose. The paper identifies regulatory gaps and challenges, such as data protocols, validation of components, early identification of software failure or misuse, clinical data and user research. It proposes increased dialogue between key stakeholders and regulators to develop a robust and flexible regulatory framework that both promotes innovation and maximizes patient safety.
The position paper also foreshadows the release of a future policy document currently under preparation by the MPP that will address challenges of regulating CCPs, with a specific focus on the “connected” elements of CPPs. This document will be shared with regulators and key stakeholders to establish a constructive dialogue.
You can read the position paper in the publications section of the MPP website