GSPR Mapping for Drug–Device Systems: Evidence Matrix Approach in 2023 GSPR Mapping for Drug–Device Systems: Evidence Matrix Approach in 2023 The regulation of drug-device combination products presents significant complexities, particularly under the EU MDR frameworks. This comprehensive guide aims to elucidate the approach of using an Evidence Matrix as a structured method for General Safety and Performance Requirements (GSPR) mapping concerning drug-device systems. In this tutorial, we will navigate through various steps that regulatory professionals must take to ensure compliance with the relevant directives, primarily focusing on the expectations under Article 117 and their implications for notified bodies. Step 1:…

UDI Strategy for Combination Products: US-to-EU Data Alignment in 2023 UDI Strategy for Combination Products: US-to-EU Data Alignment in 2023 In an era of increasing global regulatory harmonization, understanding the Unique Device Identification (UDI) strategy for combination products becomes essential. This guide serves as a comprehensive step-by-step tutorial for regulatory affairs professionals, particularly those operating at the intersection of drug and device regulations. We will cover the essential phases of developing an UDI strategy that aligns with both US and EU regulations, ensuring effective compliance and successful market authorization. Step 1: Understanding the Regulatory Framework for Combination Products Before delving…

PMS/PMCF Planning Under MDR for Drug–Device Products: Commercial Readiness in 2023 PMS/PMCF Planning Under MDR for Drug–Device Products: Commercial Readiness in 2023 In the evolving landscape of medical device regulations, particularly under the European Union Medical Device Regulation (EU MDR), the complexities surrounding Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) intensify for drug-device combination products. Ensuring compliance with these regulations is crucial for commercial success, particularly when navigating regulatory expectations from both the FDA and European authorities. This comprehensive guide provides a step-by-step approach to PMS and PMCF planning under MDR, aimed at enhancing your organization’s commercial readiness. Step…

EUDAMED Registration Readiness for Combination Products in 2023: Data Elements and Governance EUDAMED Registration Readiness for Combination Products in 2023: Data Elements and Governance In the context of the European Union’s Medical Device Regulation (EU MDR), the European Database on Medical Devices (EUDAMED) plays a critical role in enhancing the transparency and coordination of information regarding medical devices and their safety. Combination products, which comprise both drugs and devices as defined under Article 117 of the EU MDR, must adhere to specific regulatory processes, including EUDAMED registration. This article provides a structured, step-by-step tutorial for regulatory professionals who wish to…

EU MDR vs US Combination Product Rules: Global Strategy for US Manufacturers in 2023 EU MDR vs US Combination Product Rules: Global Strategy for US Manufacturers in 2023 Global manufacturers of combination products face distinct regulatory pathways in the European Union (EU) and the United States (US). Understanding these differences is critical for successful compliance and market access. This article provides a step-by-step tutorial aimed at US manufacturers, detailing the regulatory framework associated with the EU Medical Device Regulation (MDR), particularly in relation to Article 117, GSPR, Notified Bodies, and EUDAMED. We will also explore how these UK and EU…