# Updated MDCG Guidance on MDR Implementation for Legacy Devices: Key Details Explained
The European Union’s Medical Device Regulation (MDR) has introduced significant changes to the regulatory landscape for medical devices, replacing the Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD). One of the most complex aspects of the MDR transition is its impact on “legacy devices”—medical devices that were certified under the MDD or AIMDD but continue to be marketed under the MDR’s transitional provisions. To address the challenges associated with legacy devices, the Medical Device Coordination Group (MDCG) has issued updated guidance, providing clarity on compliance expectations and regulatory pathways. This article explores the key details of the updated MDCG guidance and its implications for manufacturers, notified bodies, and other stakeholders.
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## **What Are Legacy Devices?**
Legacy devices are medical devices that were CE-marked under the MDD or AIMDD and are still being placed on the market during the MDR’s transitional period. These devices are allowed to remain on the market under specific conditions outlined in Article 120(3) of the MDR, provided that their MDD/AIMDD certificates remain valid and they comply with certain MDR requirements, such as post-market surveillance (PMS), vigilance, and registration obligations.
The transitional provisions aim to ensure a smooth shift to the MDR while avoiding disruptions in the availability of critical medical devices. However, the regulatory requirements for legacy devices have raised questions and challenges, prompting the need for detailed guidance from the MDCG.
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## **Key Updates in the MDCG Guidance**
The updated MDCG guidance on MDR implementation for legacy devices provides critical clarifications and practical recommendations for manufacturers and notified bodies. Below are the key highlights:
### **1. Scope of Legacy Devices**
The guidance reaffirms the definition of legacy devices and clarifies which devices qualify under the transitional provisions. It emphasizes that legacy devices must have been certified under the MDD or AIMDD before the MDR’s date of application (May 26, 2021) and must continue to comply with the conditions of their original certification.
Additionally, the guidance addresses “up-classified” devices—devices that have been reclassified to a higher risk class under the MDR. These devices may also qualify as legacy devices if they meet the transitional criteria.
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### **2. MDR Requirements Applicable to Legacy Devices**
While legacy devices are not required to undergo full MDR conformity assessment during the transitional period, they must comply with several MDR requirements. The updated guidance provides detailed explanations of these obligations, including:
– **Post-Market Surveillance (PMS):** Manufacturers must establish and maintain a PMS system in accordance with MDR Article 83. This includes conducting post-market clinical follow-up (PMCF) where applicable.
– **Vigilance Reporting:** Legacy devices are subject to the MDR’s vigilance requirements, including the reporting of serious incidents and field safety corrective actions (FSCAs) as outlined in MDR Articles 87