EUDAMED Requirements of Legacy Device Registration in UDI Module

EUDAMED Requirements of Legacy Device Registration in UDI Module

October 18, 2023 | UDI

MDR 2017/745 and IVDR 2017/746 EU laws establish an EU identification system for medical devices based on a Unique Device Identifier (UDI) and oblige medical device manufacturers to disclose the UDI/Device information of all devices/products they place on the market. Legacy devices that will be registered in EUDAMED will need two other unique access keys (IDs) to replace the Basic UDI-DI and UDI-DI for the sake of the workability of EUDAMED.

For this purpose, a EUDAMED DI will be assigned to the device instead of the Basic UDI-DI and a EUDAMED ID will be assigned by EUDAMED instead of the UDI-DI allowing the system to work and to keep the design of EUDAMED as close as possible to the MDR design. These EUDAMED DI and EUDAMED ID will be unique for a given legacy device.

Requirements to Register a Legacy device in UDI Module

EUDAMED DI Information

1. UDI-DI if already assigned to the legacy device 2. Authorised representative for the current device 3. Basic UDI DI (applicable only for non-EU manufacturers). 4. A summary of the device’s features 5. Device name, Risk class, model

Details about the Device’s Identification

1. Previously supplied UDI-DI or the EUDAMED ID produced based on the 2. EMDN code. 3. Trade name, if available 4. Choose the language 5. A reference number/catalogue number

Certificate Details

1. Certificate type 2. NB number 3. Certificate number 4. Date of expiration 5. A revision number if one is available.

Note: For Legacy Devices, the initial status is ‘On the market’. If the device is ‘No longer on the market,’ an update of the status can be performed on the Device.

Device Specifications

1. Sterilization before use 2. Devices labelled as single or sterile 3. Storage/handling conditions 4. Critical warnings or contra-indications

Device Information

1. SRN number if the device was designed by another legal or natural person 2. Clinical Investigation reference for the current UDI-DI/EUDAMED ID if required and a Member State

Once this informationis entered in module, click on “Submit” to submit it directly or “Preview” to view before submitting: A pop-up window will appear asking you to confirm your submission. Once you confirm, you will be brought to a new window confirming the submission of your Legacy device.

Timeline for Submission

Currently, legacy devices should be understood as devices and are placed on the market after the MDR’s date of application -26 May 2021- and until 26 May 2024 if:

They are class I devices, for which an EC declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure under the MDR requires the involvement of a notified body.
They are devices covered by a valid EC certificate issued prior to 26 May 2021.

The registration of legacy devices in EUDAMED will be only required when the system will be fully functional and only in two particular cases:

By the end of the transitional period (24 months after publication in the Official Journal of the European Union) if an equivalent device is not made compliant and registered as a MDR device by that date.
In case of serious incident or field safety corrective action concerning a legacy device, such device must be registered in EUDAMED at the moment of the serious incident/field safety corrective action reporting in the Vigilance module. The Vigilance module will be available when EUDAMED is fully functional.