On 15 February 2021, the European Commission published the “Management of Legacy Devices in EUDAMED” document to explain how legacy devices are identified in EUDAMED, that is how the different Unique Device Identifiers (UDI) are created and assigned for these devices.
The information in this document expands the MDCG 2019-05 “Registration of legacy devices in EUDAMED” guideline, published in April 2019 to provide guidance on how to register legacy devices.
But what are legacy devices?
Legacy devices are defined as those Medical Devices, active implantable Medical Devices and in Vitro Diagnostic Medical Devices which are covered by a valid certificate in accordance with the 93/42/CEE (MDD), 90/385/CEE (AIMDD) or 98/79/CE (IVDD) Directives. Moreover, these devices are those which continue to be legally on the market after the date of application of the MDR (EU) 2017/745 (26 May 2021) and the IVDR (EU) 2017/746.
Registration of legacy devices in EUDAMED
Legacy devices are subject to EUDAMED requirements which are different from products with certificates issued in accordance with MDR and IVDR Regulations.
As explained in the “Management of Legacy Devices in EUDAMED” document, Manufacturers can register any legacy device in the EUDAMED database to facilitate Post-Market Surveillance (PMS) and manage adverse events.
Registration is mandatory if there is a serious incident involving the product, or if the device is subject to corrective safety action in the field which requires registration before a final supervisory report or a follow-up report is submitted.
Legacy devices shall also be registered in EUDAMED within 18 months after the date of application of the MDR or IVDR, or within 24 months following the publication of the notice referred to in Article 34, paragraph 3, of the MDR (notice reported to the European Commission that verifies the achievement of the full functionality of EUDAMED), if the database is not fully functional by the date of application of the MDR.
Identification requirements for legacy devices
Legacy devices are subject to MDR or IVDR registration requirements, with some exceptions such as the assignment of a basic UDI-DI (the main access key for device information in the EUDAMED database) and a UDI-DI (the numeric or alphanumeric code which identifies the Manufacturer and the device).
However, to ensure that all devices registered in EUDAMED have elements of identification, for legacy devices the following codes are required: EUDAMED DI that is the equivalent of the basic UDI-DI and EUDAMED ID which is the equivalent of the UDI-DI. These codes shall only be used in the EUDAMED database when entering data to register legacy devices.
In the document, there are examples of code assignments for identifying legacy devices in EUDAMED and the explanation of how legacy device registration takes place once it becomes compliant with the MDR or IVDR. Finally, information on the format of the EUDAMED DI code is provided in annex 1.
Do you want assistance in registering in EUDAMED?
Thema experts are available to proceed on your behalf or support you in the EUDAMED registration up until the notification to the Ministry of Health of the Member State where the economic operator submitting the application is based. The Ministry will then issue the SRN (Single Registration Number) upon the activation of the authorisation.
Visit the Italian and European ministerial registrations page to find out how we can help you or contact us to request advice.
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