EU MDR compliance for Legacy Devices: An Overview
Legacy devices encompass a range of medical products including medical devices, active implantable medical devices, and in vitro diagnostic devices. These devices have been granted valid certificates under the Medical Devices Directive (MDD) or Active Implantable Medical Device Directive (AIMDD), with CE marking certificates issued according to Directives 93/42/EEC, 90/85/EEC, or 98/97/EC.
For more details on CE marking, you can also explore our service page on the CE mark for medical devices.
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Registration of Legacy Devices:
Mandatory registration of legacy devices in EUDAMED (European Database for Medical Devices) is required, especially in cases of serious incidents or the necessity for field corrective actions.
New Identifiers for Legacy Devices:
Legacy devices are assigned new identifiers – EUDAMED-DI and EUDAMED ID, replacing previously assigned UDI-DI.
New Guidance on EU MDR Compliance for Legacy Medical Devices:
The European Commission’s Medical Device Coordination Group (MDCG) has issued guidance on implementing and applying MDR requirements for legacy devices, including those placed in the market before May 26, 2021. This guidance addresses transitional provisions and distinguishes medical devices into Legacy and Old categories.
Requirements Set Out in Chapter VII of the MDR:
Chapter VII of the MDR outlines essential requirements for post-market surveillance, market surveillance, and vigilance, applicable to legacy devices. Notified bodies are responsible for ensuring appropriate surveillance and new requirements during the transition period.
Other MDR Requirements for Legacy Devices:
Additional MDR requirements, particularly those related to post-market surveillance, market surveillance, vigilance, and registration of economic operators and devices, must be met by legacy devices.
New Requirement for Old Devices:
While MDR requirements may not apply to old devices, competent authorities’ rights and obligations regarding market surveillance still apply, ensuring device safety and compliance with present regulations.
Conclusion:
MDCG’s new guidance aids manufacturers in classifying legacy devices according to MDR requirements before their placement in the European market. Legacy devices must adhere to MDR requirements based on their MDD classification. Active implantable devices under AIMDD are considered Class III devices during the transition period. Manufacturers must update periodic safety reports and ensure conformity with current rules. While this guidance may not apply to older devices, competent authorities still monitor their conformity with present regulations.
For Expert Assistance in EU MDR Compliance for Legacy Devices
Specialized EU MDR Compliance Services by Operon Strategist
Operon Strategist, a dedicated medical device regulatory consulting company, works in coordination with various regulatory bodies to provide clients with regulatory services, assisting manufacturers in obtaining CE marks for medical devices.
For expert guidance on EU MDR compliance and regulatory consulting services tailored to your medical devices, contact Operon Strategist today.
