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October 2024
The Medical Device Coordination Group (MDCG) has issued comprehensive guidance on the application of the Medical Device Regulation (MDR) requirements to legacy devices—those placed on the market before 26-May-2021. This document clarifies the transitional provisions of Regulation (EU) 2017/745 on Medical Devices (MDR), providing essential details for stakeholders on meeting the new regulatory standards.
Key Points Covered in the Guidance:
Transitional Period Extension:
The transitional period for legacy devices has been extended until 31-Dec-2027 or 31-Dec-2028, depending on the device’s risk class and specific conditions.
Definition and Classification:
Clear definitions and classification criteria for legacy devices to ensure they align with MDR requirements.
Transitional Provisions:
Detailed explanations of how the MDR applies to legacy devices, including any exemptions or specific conditions.
Post-Market Surveillance:
Manufacturers, importers, and distributors must comply with post-market surveillance requirements, even for legacy devices, including monitoring device performance and reporting adverse events.
Obligations of Manufacturers, Importers, and Distributors:
Responsibilities include ensuring compliance with updated labeling, safety standards, and documentation requirements.
Surveillance and Reporting:
Clear guidelines on market surveillance responsibilities, including device traceability, UDI (Unique Device Identification) assignment, and reporting obligations.
Exemptions:
Details on any potential exemptions from full MDR compliance for specific devices, depending on their risk classification.
UDI Assignment and Market Surveillance:
Emphasis on the assignment of UDI and market surveillance activities to maintain traceability and safety.
This guidance ensures that manufacturers, importers, and distributors of legacy devices can meet the MDR requirements effectively, with clarity on the transitional periods, surveillance responsibilities, and compliance obligations.
Region: EU Harmonized (27 Markets)
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