GSPR Compliance: General Safety and Performance Requirements in MDR GSPR Compliance: General Safety and Performance Requirements in MDR The European Medical Device Regulation (MDR) sets forth stringent guidelines aimed at ensuring the safety and performance of medical devices. Among these guidelines are the General Safety and Performance Requirements (GSPR), which are critical for compliance and the successful market entry of medical devices in the EU. This article provides a step-by-step tutorial focused on GSPR compliance, detailing actionable insights and documentation expectations for regulatory affairs professionals, particularly those involved in FDA combination product consulting. Step 1: Understanding the Scope of GSPR…

EUDAMED Registration Requirements for Drug-Device Products EUDAMED Registration Requirements for Drug-Device Products As the pharmaceutical and medical device landscape evolves, understanding the regulatory requirements surrounding drug-device products is essential for compliance and market access. The European Union Medical Device Regulation (EU MDR) necessitates that drug-device products are registered in the EUDAMED database. This guide provides a comprehensive, step-by-step approach to navigating the EUDAMED registration process specifically for drug-device products, aligned with the EU MDR guidelines, particularly focusing on Article 117 implications. Our aim is to assist US-based professionals in ensuring that they meet the regulatory expectations from the onset of…

Labeling and IFU Requirements for Combination Devices Under MDR Labeling and IFU Requirements for Combination Devices Under MDR Understanding the complexities surrounding the labeling and instructions for use (IFU) requirements for combination devices under the Medical Device Regulation (MDR) is critical for compliance and market access. This step-by-step guide provides a detailed approach to ensure adherence to the regulatory landscape, particularly focusing on the European Union’s MDR framework while considering pertinent guidelines for FDA combination products. Step 1: Understand the Definition and Scope of Combination Devices A combination device as per both the FDA and EU MDR regulations integrates a…

Postmarket Clinical Follow-up (PMCF) and PMS Under MDR Postmarket Clinical Follow-up (PMCF) and PMS Under MDR: A Step-by-Step Guide In the context of the Medical Device Regulation (MDR), Postmarket Clinical Follow-up (PMCF) and Post-Market Surveillance (PMS) play pivotal roles in ensuring the safety and performance of medical devices throughout their lifecycle. This article presents a detailed step-by-step guide for professionals involved in regulatory affairs, clinical operations, quality assurance, and product teams focusing on compliance with PMCF and PMS under the MDR. Step 1: Understanding PMCF and PMS Requirements Before diving into PMCF and PMS activities, it’s essential to understand the…

Legacy Devices in Combination Products: Regulatory Path Under MDR Legacy Devices in Combination Products: Regulatory Path Under MDR The regulatory landscape for legacy devices in combination products under the EU Medical Device Regulation (MDR) is complex and multifaceted. This article aims to provide a detailed, step-by-step tutorial guide for regulatory affairs professionals engaged in the development, submission, and oversight of legacy devices in combination products. Specifically, the focus will be on the obligations under the MDR, including Article 117 and the involvement of Notified Bodies, General Safety and Performance Requirements (GSPR), and other essential components. By the end of this…

CE Marking Strategy for Drug-Device Integrations CE Marking Strategy for Drug-Device Integrations In the contemporary landscape of healthcare, the integration of drug and device modalities raises critical regulatory challenges, especially when aiming for CE Marking under the European Union Medical Device Regulation (EU MDR). This guide serves as a comprehensive walkthrough for US-based regulatory professionals looking to navigate the complexities associated with CE Marking strategies for drug-device integrations, particularly under Article 117 of the EU MDR. Step 1: Understanding the Regulatory Framework The regulatory landscape governing drug-device combinations is marked by numerous directives, guidelines, and regulations. To effectively guide your…

EU MDR Implementation Challenges for Global Pharma Companies EU MDR Implementation Challenges for Global Pharma Companies The European Union Medical Device Regulation (EU MDR) has brought significant changes to the regulatory framework for medical devices, posing unique challenges for global pharmaceutical companies. Understanding and navigating these changes is essential for compliance and successful market access within the EU. This guide provides a comprehensive, step-by-step approach to address the implementation challenges of EU MDR, specifically tailored for U.S.-based companies. Step 1: Understanding EU MDR Requirements The first and foremost step in the EU MDR implementation process is to comprehensively understand the…

EU MDR Article 117 Implementation Plan for Drug–Device Combinations in 2023: Documentation Checklist EU MDR Article 117 Implementation Plan for Drug–Device Combinations in 2023: Documentation Checklist The implementation of Article 117 under the EU Medical Device Regulation (EU MDR) places significant demands on stakeholders involved in drug-device combinations. This comprehensive guide outlines the step-by-step process necessary to ensure compliance with Article 117, providing a detailed checklist for documentation and submissions. By following these structured actions, you can effectively navigate the regulatory landscape for drug-device products. Step 1: Understand the Regulatory Framework Article 117 of the EU MDR specifically pertains to…

Notified Body Opinion (NBOp) for Article 117: How US Sponsors Prepare in 2023 Notified Body Opinion (NBOp) for Article 117: How US Sponsors Prepare in 2023 The implementation of Article 117 of the EU Medical Device Regulation (EU MDR) marks a significant transition for US sponsors developing combination products that incorporate medicinal substances. Navigating the requirements for Notified Body Opinion (NBOp) can be daunting, given the stringent expectations set forth by European legislation. This guide aims to provide a step-by-step tutorial on how US sponsors can prepare for the NBOp process effectively, ensuring compliance and optimizing the chances for a…

MDR Annex II Technical Documentation for Combination Products: Practical Template in 2023 MDR Annex II Technical Documentation for Combination Products: Practical Template in 2023 The landscape of medical regulations continues to evolve, necessitating a thorough understanding of the requirements specified in the European Union Medical Device Regulation (EU MDR), particularly for combination products. This article provides a comprehensive, step-by-step tutorial on preparing the technical documentation as outlined in Annex II of the EU MDR. Aimed at US regulatory affairs professionals, this guide elucidates crucial documentation expectations and practical actions needed for successful compliance and submission. Step 1: Understanding Combination Products…