**Updated MDCG Guidance on MDR Compliance for Legacy Medical Devices**
The European Union’s Medical Device Regulation (MDR) 2017/745 has introduced a more stringent regulatory framework for medical devices, aiming to ensure higher safety standards, improved transparency, and better traceability. However, the transition from the previous Medical Device Directive (MDD) to the MDR has posed significant challenges for manufacturers, particularly for “legacy devices”—those medical devices that were certified under the MDD or the Active Implantable Medical Devices Directive (AIMDD) and are still being placed on the market under the MDR’s transitional provisions. To address these challenges, the Medical Device Coordination Group (MDCG) has issued updated guidance to clarify compliance requirements for legacy devices.
This article explores the key aspects of the updated MDCG guidance, its implications for manufacturers, and practical steps to ensure compliance.
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### **What Are Legacy Medical Devices?**
Legacy devices are medical devices that were certified under the MDD or AIMDD and continue to be marketed under the MDR’s transitional provisions. These devices are allowed to remain on the market until their MDD/AIMDD certificates expire, provided they meet certain conditions outlined in Article 120(3) of the MDR. However, they must comply with specific MDR requirements, such as post-market surveillance (PMS), vigilance, and registration obligations.
The updated MDCG guidance provides clarity on how manufacturers can meet these requirements while ensuring a smooth transition to the MDR framework.
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### **Key Highlights of the Updated MDCG Guidance**
The MDCG guidance, issued in 2023, builds on earlier documents and provides detailed instructions for manufacturers, notified bodies, and other stakeholders. Below are the key highlights:
#### **1. Post-Market Surveillance (PMS) Requirements**
Under the MDR, legacy devices must comply with enhanced PMS requirements. The updated guidance emphasizes the need for manufacturers to establish and maintain a PMS system that is proportionate to the risk class and intended use of the device. This includes:
– **Periodic Safety Update Reports (PSURs):** For Class IIa, IIb, and III devices, manufacturers must prepare PSURs summarizing the results of PMS activities, including trend analysis and conclusions about the device’s safety and performance.
– **Post-Market Clinical Follow-Up (PMCF):** Manufacturers must conduct PMCF activities to gather clinical data on the device’s performance and safety in real-world use.
The guidance provides templates and examples to help manufacturers implement these requirements effectively.
#### **2. Vigilance and Incident Reporting**
Legacy devices must comply with the MDR’s vigilance requirements, which include reporting serious incidents and field safety corrective actions (FSCAs) to the relevant competent authorities. The updated guidance clarifies the timelines for reporting and provides a harmonized approach to incident classification.
#### **3. Economic Operator Obligations**
The guidance reiterates the roles and responsibilities of economic operators, including manufacturers, authorized representatives, importers, and distributors. It