Philips Engineering Solutions contributes to position paper on the legislative framework for Connected Combined Products in the European Union
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 Novartis, Sanofi, SFL Regulatory Affairs & Scientific Communication, Swiss Medtech, Ypsomed, Anteris Helvetica, Merck, Sharp and Dohme, Aquilon Pharmaceuticals, Edwards Lifesciences, Covance, Boehringer-Ingelheim and Philips Engineering Solutions. Marc Schoenmakers, Q&R medical device compliance at Philips Engineering Solutions, chaired this working group.
This position paper proposes for the first time a definition for CCPs and provides examples that include medicinal products, drug delivery devices, medical device software and the use of mobile platforms and cloud applications. The paper identifies regulatory gaps and challenges, such as system related patient safety, cybersecurity, compliance and safety of data protocols, medical validation of initially non-medical components, early identification of system-software failure and potential misuse. It proposes increased dialogue between key stakeholders and Regulators to develop a robust and efficient Regulatory framework that both promotes innovation and maximizes patient safety.
“In addition to the ‘combined’ element of the CCP which has its regulatory challenges in itself, the ‘connected’ part of Connected Combined Products adds new complexity. We see more and more need for usage of IoT system components, like comprehensive software algorithms, innovative sensor technology, mobile platforms and cloud applications that are not necessarily complying to medical regulations. However, they can offer great value to medical device innovations like CCPs.
It’s important to identify the overall system risks, company liabilities and product compliance when system elements are used that initially were designed with a non-medical intent”, says Marc Schoenmakers. “With this paper we want to create awareness for the regulatory complexity of ‘combined’ and ‘connected’ as a medical device to non-medical regulated IoT applications. We want to emphasize that the use of non-medical-regulated system elements entail potential risks for patients. This paper is a first step in creating awareness.”
The position paper also foreshadows the release of a future policy document currently under preparation by the MPP that will address the challenges of regulating CCPs, in more depth. This document will be shared with Regulators and key stakeholders to establish a constructive dialogue.
Philips Engineering Solutions and Medtech & Pharma Platform
Philips Engineering Solutions recently joined the Medtech & Pharma platform as a member. The MPP is an international industry association dedicated to enhancing synergies between medical device and pharmaceutical companies. Philips Engineering Solutions aims to contribute to the development of complex connected combined products at the intersection of pharmaceuticals, medical devices, and digital healthcare applications. In addition, by its membership, Philips Engineering Solutions can contribute to the engagement with relevant European stakeholders to collaborate on a proportionate policy framework, with an ultimate goal to improve access to innovative connected combined products.
You can read the position paper on the MPP website.