Understanding MDD CE Marked Devices as Legacy Medical Devices

In the realm of medical device regulation, the term "legacy device" often conjures images of outdated technology. However, it's essential to recognize that even devices bearing the CE mark under the Medical Device Directive (MDD) fall under this category as regulations evolve.

Also, below you will find the new EUDAMED guidance for legacy devices.

Defining Legacy Devices:

Legacy devices encompass a broad spectrum of medical technologies that have been in use and approved under previous regulatory frameworks, such as the MDD. These devices, while still serving critical healthcare needs, must adapt to meet the requirements of newer regulations like the Medical Device Regulation (MDR).

MDD CE Marked Devices as Legacy:

A device that has obtained CE marking under the MDD is considered a legacy device in the context of regulatory transitions. Despite their prior approval and conformity to MDD standards, these devices must undergo assessment and adaptation to comply with the more stringent criteria outlined in the MDR.

Implications of Legacy Status:

Understanding the legacy status of MDD CE marked devices is crucial for manufacturers, regulators, and healthcare providers alike. It signifies the need for proactive measures to ensure continued compliance, market access, and patient safety in alignment with current regulatory requirements.

As regulatory landscapes evolve, manufacturers of MDD CE marked devices must navigate the transition to MDR compliance. This process involves updating technical documentation, conducting additional testing if necessary, and collaborating with notified bodies to ensure adherence to MDR standards. Now, legacy devices must be registered in EDUAMED.

Conclusion:

In the dynamic field of medical device regulation, the classification of MDD CE marked devices as legacy devices underscores the need for ongoing adaptation and compliance efforts. By recognizing and addressing the implications of this status, stakeholders can work together to uphold the highest standards of safety and efficacy in healthcare delivery.

Check the updated document regarding EUDAMED registration below!