The European Commission have released three guidance documents, which include two on the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) and the data from the unique device identifier (UDI) which needs to be included in the Eudamed database of devices and IVDs. The third document concerns the Eudamed device data dictionary.
The MDR document notes that, in addition to the manufacturer name and basic UDI-DI value, companies are required to indicate if the device is implantable or a reusable surgical instrument. The IVDR document states the requirement for information on whether the IVD is for self-testing, or if it’s a companion diagnostic, or a reagent, or intended to administer or remove a medicinal substance, or for professional testing.
The third document on the Eudamed device data dictionary is in the form of an Excel spreadsheet, and the European Commission have stated that the purpose of this document is “to give an understanding over the data that is to be provided to Eudamed and that can be communicated through Data Exchange process for the UDI/Device module. The document presents the different attributes related to UDI/Device that may be communicated through XML, their correspondence to the fields from EUDAMED User Interface, the description of each field apart and the Rules applying at the level of the Entity of for each specific field apart.”
To read the MDR guidance on UDI and device data sets to provide in Eudamed, please click here.
To read the IVDR guidance on UDI and device data sets to provide in Eudamed, please click here.
To read the guidance on the Eudamed device data dictionary, please click here.