Legacy devices are those that were approved under the previous MDD but are still in use or available on the market. The regulation (EU) 2023/607 provides a lifeline for these devices, offering a mechanism for extending their certificate validity and ensuring continued market access. Manufacturers of legacy devices benefiting from the extension under Regulation (EU) 2023/607 are required to comply with the mandatory actions recently outlined by the Ministry of Health (MoH) within the Italian medical devices database within May, 26 2024, as the following:
Certificate Extension for MDD-Certified Devices
For devices that hold a CE marking under MDD certification, the regulation offers a pathway to extend certificate validity. Manufacturers must update their certification status in the dedicated section of the MoH database, selecting the “Extension of Certificate Validity – Regulation (EU) 2023/607” option. This process is critical for ensuring that legacy devices can remain on the market while transitioning to the new MDR requirements.
Class I Devices requiring the intervention of a Notified Body for MDR Assessment
For Class I devices, which are not covered by an MDD certificate and require a Notified Body’s involvement for MDR conformity assessment, face their unique set of challenges, manufacturers must use the re-processing function and update the device documentation accordingly. The system automatically determines the end date for placing the device on the market based on the specific case.
Regulatory Pharma Net is committed to assisting manufacturers in directly managing the necessary actions to ensure compliance for their legacy devices in the Italian MoH database.
Feel free to contact us at info@regulatorypharmanet.com