# Updated MDCG Guidance on MDR Implementation for Legacy Medical Devices
The European Union’s Medical Device Regulation (MDR) 2017/745 has brought 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 and are still being marketed under the MDR’s transitional provisions. To address the challenges associated with these devices, the Medical Device Coordination Group (MDCG) has issued updated guidance to clarify the requirements and ensure a smoother transition for manufacturers, notified bodies, and other stakeholders.
This article provides an overview of the updated MDCG guidance on MDR implementation for legacy medical devices, highlighting key provisions, implications, and practical steps for compliance.
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## **What Are Legacy Medical Devices?**
Legacy medical devices are products that were certified under the MDD or AIMDD and continue to be placed on the market 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 detailed instructions on how manufacturers and notified bodies should handle these devices during the transition period, ensuring compliance with the MDR while maintaining patient safety and market continuity.
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## **Key Highlights of the Updated MDCG Guidance**
The updated MDCG guidance addresses several critical aspects of MDR implementation for legacy devices, including:
### **1. Scope of Legacy Devices**
The guidance clarifies which devices qualify as legacy devices under Article 120(3) of the MDR. These include:
– Devices with valid MDD/AIMDD certificates issued before May 26, 2021.
– Devices that continue to be placed on the market under the conditions of their existing certificates.
– Devices that have not undergone significant changes in design or intended purpose since their certification.
The guidance emphasizes that any significant changes to the design or intended purpose of a legacy device would require the device to undergo MDR certification.
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### **2. Post-Market Surveillance (PMS) and Vigilance**
Legacy devices must comply with the MDR’s PMS and vigilance requirements, even if they are not fully certified under the MDR. The updated guidance provides detailed instructions on how manufacturers should implement these requirements, including:
– Establishing and maintaining a PMS plan in accordance with MDR Article 83.
– Conducting periodic safety update reports (PSURs) for Class IIa, IIb, and III devices.
– Reporting serious incidents and field safety corrective actions (FSCAs) in compliance with MDR Article 87.
The MDCG emphasizes the importance of robust PMS and vigilance systems to ensure the continued safety and performance of legacy