Medtech & Pharma Platform Association
Budget
€200 — €0
EP Access
0
accredited persons
Staff
2
0.75 FTE
EU Grants
None
Mission & Goals
The Medtech & Pharma Platform Association (MPP) is a European cross-sectoral not-for-profit industry association focusing on combined products, i.e. products that combine drugs, devices, diagnostics and/or digital elements to fulfill a medical purpose. Members are medtech, diagnostic, pharma and tech companies as well as organizations dedicated to enhancing synergies between the sectors. Current and future innovative healthcare solutions increasingly rely on combined products, integrating various combinations of pharma, medtech and digital technologies. MPP offers expertise and seeks dialogue with relevant stakeholders to collaborate on a proportionate regulatory framework for combined products, with a view to facilitate patient access to innovation, foster European competitiveness and enhance the safety of health data.
EU Legislative Interests
The Medtech & Pharma Platform Association was founded in 2017 and started its activities in 2018. The Medtech & Pharma Platform monitors EU legislative, policy and regulatory developments relating to combined products. Specifically, the Medtech & Pharma Platform follows: • Medical Devices Regulation EU 2017/745 & In vitro Diagnostics Regulation EU 2017/746 and their implementing and delegated acts as well as any related guidance document • Targeted evaluation of the MDR/IVDR • Medicinal Products Directive EU 2001/83 • EU Pharmaceutical Strategy • Revision of the EU basic pharmaceutical legislation • Advanced Therapy Medicinal Product Regulation EU 1394/2007 • Regulation on Health Technology Assessment EU 2021/2282 • EMA Quality Innovation Group • Regulation on standards of quality and safety for substances of human origin • Regulation on the classification, labelling and packaging of chemicals • General Data Protection Regulation EU 2016/679 • Clinical Trials Regulation EU 536/2014 • Accelerating Clinical Trials in the EU (ACT EU) • Implementation of the Union list of critical medicines • Critical Raw Materials Act • Policy initiatives, projects, events and publications from DG SANTE, DG GROW, DG CONNECT, DG RESEARCH & INNOVATION • European Health and Digital Executive Agency (HaDEA) • Health emergency preparedness and response authority (HERA) • European Industrial strategy • European Digital Strategy and Artificial Intelligence • Horizon Europe • European Health Data Space • Data Governance Act and Data Act • Regulation on Artificial Intelligence • EU AI Observatory • EU Beating Cancer Plan • European Health Union • Intellectual property action plan • Regulation of Ethylene Oxide • Regulation of Per- and polyfluoroalkyl substances (PFAS) • EMA draft reflection paper on AI and ML • EMA “COMBINE” Project • Proposed European Biotech Act • Proposed Critical Medicines Act • Institutional agreement Switzerland-EU
Communication Activities
Stakeholder engagement, projects: The MPP engages with relevant stakeholders on a European level, offers expertise and seeks dialogue to collaborate on a proportionate regulatory framework for combined products. MPP has three active working groups: • Working Group on Combined Products, focusing on co-packaged and non co-packaged drug-device-combinations and single integral combination products, • Working Group on Connected Combined Products, focusing on connected combined products including drugs, medical devices, in-vitro diagnostics, digital applications, • Working Group on In Vitro Diagnostics and Companion Diagnostics. Publications: • Position paper on impact of IVDR on use of in-house devices in clinical trials, October 2024 • MPP Association statement on the AI ACT, March 2024 • Report on integral and non-integral drug-device combination products, February 2024 • Position paper on the Interface between the EU MDR, IVDR and CTR: Challenges in conducting clinical trials involving medicinal products with medical devices or IVDs, September 2023 • Paper on regulatory pathways for connected combined products, examining the challenges associated with regulatory pathways in the EU for a subset of connected combined products consisting of a medicinal product used with a delivery device with wireless connectivity to a standalone software, September 2023 • T.C. Kühler and al., Development and Regulation of Connected Combined Products: Reflections From the Medtech & Pharma Platform Association, Clinical Therapeutics, Volume 44, ISSUE 5, P768-782, 1 May 2022 • MPP Best Practice Guide for clinical trials with integral Drug-Device Combination Products including change control and usability studies, December 2020 • Position paper on the legislative framework for Connected Combined Products, October 2020 • Reflection paper on regulatory uncertainties for co-packaged and cross-labelled drug-device combinations under the new Medical Device Regulation, December 2019 • White Paper on EU regulatory and policy framework for combined products, October 2018 Events: • MPP annual conference: The annual MPP conference is the leading event in the sector of products and solutions that combine pharma, medtech, diagnostic and digital components. The event is dedicated to enhancing synergies between these sectors. The conference provides a forum to exchange knowledge, identify new challenges and opportunities, initiate collaborations and propose improvements to regulatory frameworks and policy, toward the goal of improving patient access to innovative combined products • MPP webinars: The MPP Association offers webinars providing comprehensive and up-to-date insights on the latest regulatory and legislative developments related to combined products, medicinal products, medical devices, and in-vitro diagnostics.
Interests Represented
Promotes their own interests or the collective interests of their members
Member Of
N/A
Organisation Members
https://www.medtech-pharma.com/members
Additional Information
MPP is funded by membership contributions.
Commissioner Meetings
No recorded meetings with EU commissioners.