**MDCG Issues Updated Guidance on MDR Implementation for Legacy Medical Devices**
The European Union’s Medical Device Regulation (MDR) has introduced a more stringent regulatory framework for medical devices, aiming to enhance patient safety, improve transparency, and ensure the quality of medical devices across the EU. However, the transition from the previous Medical Device Directive (MDD) to the MDR has posed significant challenges for manufacturers, particularly for “legacy devices”—those that were certified under the MDD or the Active Implantable Medical Devices Directive (AIMDD) and are still being marketed under the MDR’s transitional provisions. To address these challenges, the Medical Device Coordination Group (MDCG) has issued updated guidance to clarify the implementation of MDR requirements for legacy devices.
This article explores the key aspects of the updated MDCG guidance, its implications for manufacturers, and the steps stakeholders need to take to ensure compliance.
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### **What Are Legacy Devices?**
Legacy devices are medical devices 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 certificates expire, provided they comply with certain MDR requirements, such as post-market surveillance (PMS), vigilance, and registration obligations.
The transitional provisions aim to prevent market disruptions and ensure the continued availability of critical medical devices while manufacturers work toward full MDR compliance. However, the regulatory landscape for legacy devices is complex, as these products must meet a hybrid set of requirements from both the MDD/AIMDD and the MDR.
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### **Key Updates in the MDCG Guidance**
The MDCG’s updated guidance provides much-needed clarity on several aspects of MDR implementation for legacy devices. Below are the key highlights:
#### **1. Scope of Legacy Devices**
The guidance reaffirms the definition of legacy devices and specifies the conditions under which they can remain on the market. It emphasizes that legacy devices must have valid MDD/AIMDD certificates and must not undergo significant changes in design or intended purpose, as such changes would require full MDR certification.
#### **2. Post-Market Surveillance (PMS) and Vigilance**
Legacy devices are subject to MDR requirements for PMS and vigilance. The updated guidance outlines the specific obligations for manufacturers, including:
– Establishing and maintaining a PMS system 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 guidance also provides examples of best practices for implementing PMS and vigilance systems for legacy devices.
#### **3. Economic Operators and Registration**
The MDCG guidance highlights the responsibilities of economic operators (e.g., manufacturers, authorized representatives, importers, and distributors) in ensuring compliance with MDR requirements. It also clarifies the registration obligations for legacy devices in the European Database on Medical Devices (EUDAM