MEDIMARK EUROPE LAST NEWS:
New announcement from the EC Commission on April 11, 2022:
The EUDAMED UDI/Devices module updated technical documentation is available
https://ec.europa.eu/health/medical...
UDI/Devices registration
Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices introduce an EU device identification system based on a unique device identifier (UDI) allowing easier traceability of medical devices. This requires that manufacturers submit in EUDAMED the UDI/Device information of all devices they place on the EU market. Manufacturers can already enter UDI/Device information in the system on a voluntary basis.
The European Commission is not in a position to require the use of the UDI/Devices registration module until EUDAMED is fully functional according to the Medical Device Regulation. Therefore, additional national requirements on registrations cannot be excluded.Relevant documents and links on UDI/Device registration are published below.
Infographics
• Basic UDI-DI and UDI-DI concept
• Categorisation of devices
• Registration process User Guide
• UDI/Devices User Guide for Economic Operators UDI/Devices Data setsOverview of the MDR UDI and device data sets and IVDR UDI and device data sets to provide for their registration in EUDAMED
Technical documentation
• EUDAMED UDI/Device data dictionary V2.7- This document clarifies the data to provide in EUDAMED for the UDI device registration module
• UDI Device Business rules v2.7- This document contains the constraints, limitations and business rules that drive the implementation of EUDAMED
• UDI Device enumerations v2.7- This document contains the value lists for drop down elements and lists where a limited set of values can be selected
• DTX service definition for economic operators v2.7
• Economic Operators DTX notes v2.7
• EO - XML samples v2.7UDI Helpdesk
The UDI helpdesk provides support to economic operators in the implementation of the obligations and requirements introduced by the new UDI system, including UDI assignment, labelling and registration of devices.This helpdesk also provides support as regards the use of the European Medical Devices Nomenclature (EMDN).
European Medical Device Nomenclature (EMDN)
The EMDN is the nomenclature to be used by manufacturers when registering their medical devices in EUDAMED.
The EMDN is fully available in the EUDAMED public siteFor more information on the EMDN, see also EMDN Q&A
Registration of legacy devices
Currently, legacy devices should be understood as devices, which, in accordance with Article 120(3) of the Regulation (EU) 2017/745 (MDR), 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 under Directive 93/42/EEC, 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 in accordance with Directive 90/385/EEC or Directive 93/42/EEC 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 of the notice referred to in Regulation (EU) 2017/745 Article 34(3)) 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.
You will find more information about legacy devices in the links below:
• MDCG 2019-5 Registration of legacy devices in EUDAMED
• MDCG 2021-25 - Application of MDR requirements to "legacy devices" and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC
• Management of Legacy devices in EUDAMED
• Infographic – Legacy device identifiers Guidance
Guidance on the application of legislation particularly in the Unique Device Identifier (UDI) and EUDAMED sections
Useful links
• Unique device identifier
• EUDAMED public
• EUDAMED restricted