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“Updated MDCG Guidance on MDR Implementation for Legacy Medical Devices: Key Details”

# Updated MDCG Guidance on MDR Implementation for Legacy Medical Devices: Key Details

The European Union’s Medical Device Regulation (MDR) 2017/745 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 and are still being 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 on MDR implementation for legacy medical devices.

## **What Are Legacy Devices?**

Legacy devices are medical devices that were CE-marked under the MDD or AIMDD and continue to be placed on the market during the MDR’s transitional period. These devices are allowed to remain on the market under specific conditions, as outlined in Article 120(3) of the MDR. However, they must comply with certain MDR requirements, such as post-market surveillance (PMS), vigilance, and registration obligations, even though they were not originally certified under the MDR.

The updated MDCG guidance provides detailed instructions on how manufacturers, notified bodies, and other stakeholders should manage legacy devices during this transitional period to ensure compliance and patient safety.

## **Key Updates in the MDCG Guidance**

The updated MDCG guidance introduces several important clarifications and recommendations for the implementation of MDR requirements for legacy devices. Below are the key details:

### **1. Extended Transition Periods**
The MDCG guidance reflects the extended transition periods introduced by the MDR amendments in early 2023. These extensions aim to prevent market disruptions and ensure the continued availability of critical medical devices. Legacy devices with valid MDD or AIMDD certificates can remain on the market until the new deadlines, provided they meet specific conditions, such as ongoing compliance with PMS and vigilance requirements.

### **2. Post-Market Surveillance (PMS) and Vigilance**
Legacy devices must comply with the MDR’s PMS and vigilance requirements, even if they were certified under the MDD or AIMDD. The updated guidance emphasizes the following:

– **PMS Plans:** Manufacturers must develop and maintain PMS plans in accordance with MDR Article 84. These plans should include proactive and systematic processes for collecting and analyzing data on device performance and safety.
– **Periodic Safety Update Reports (PSURs):** For Class IIa, IIb, and III devices, manufacturers must prepare PSURs as outlined in MDR Article 86. The guidance provides templates and examples to help manufacturers meet this requirement.
– **Vigilance Reporting:** Legacy devices are subject to MDR vigilance reporting requirements, including the reporting of serious incidents and field safety corrective actions (FSCAs).

### **3. Economic Operators and Registration