EU EUDAMED Update
Updates continue to be issued from both the European Commission and industry concerning EUDAMED in light of the current COVID-19 pandemic. The latest information sets new expectations about the availability of modules and expected activity. The outlook is positive for manufacturers, with ample time to plan and prepare UDI data. The latest timeline indicates the following:
- 2020 December: The EUDAMED Actor module is assumed to be a voluntary, production deployment this coming December. At that time, economic operators will be able to interface with EUDAMED and acquire the needed registration SRN (Single Registration Number) for certificates. Since we last reported in May, this is good news. Before this announcement, it was assumed the EUDAMED Actor module would be delayed to 2021 March.
- Expected By 2021 May: EUDAMED Device/UDI Registration, Certificates and Notified Bodies modules (after the Actor module, as soon as functional). At this time, it is anticipated that manufacturers will be able to begin submitting UDI information to EUDAMED.
- 2021 May: MDR DoA (Date of Application)
- 2022 May: IVDR DoA (Date of Application)
- 2022 May: EUDAMED Launch (all modules complete and released)
- 2022 May-2023 Nov: EUDAMED Device Registration period of 18 months for Legacy, MDR, and IVDR devices
As conditions change, further information and guidelines are expected from the European Commission.
Reed Tech Solutions
Reed Tech customers are currently getting acquainted with the UAT and live production environments for SingleSource™ for Medical Devices-EU UDI, released 2020 May. Customers now have the ability to import, validate and view EUDAMED UDI data along with access to data collection templates and other guidelines. With development continuing as new guidance documents are released, customers will gain valuable experience in understanding the nuances of EUDAMED as compared to other global regulators.
To date, Reed Tech has successfully completed all test scenarios supported by the EUDAMED machine-to-machine playground environment – including the submission of over 2,750 UDI records. In discussions with customers and others, we find that the majority of manufacturers are continuing forward in their efforts, using the extra time to their advantage.
Some of the critical activities that can be achieved in advance of the EUDAMED go-live are below. Many MDR clauses address transition issues and new regulations that do not involve reporting information to EUDAMED. Some of these requirements are listed below:
- Assign Basic UDI-DI – Manufacturers must create and assign Basic UDI-DI values to their MDR-compliant products to support MDR-compliant documentation prior to placing the product on the market [MDR Article 29(1), (3)].
Note: To ensure self-certified Class I devices continue to be placed on the market without interruption after the MDR DoA, the BUDI-DI assignment and technical documentation should be done well before the MDR DoA.
- Place UDI on Labels – Manufacturers must place UDI on MDR device labels according to device class [MDR Article 123(3)(f)].
- Place UDI on Products – If the reusable MDR device requires direct marking, manufacturers must place UDI directly on the product according to device class [MDR Article 123(3)(g)].
- Transition from MDD to MDR Certificates – Directive certificates (MDD/AIMDD) cannot be issued or renewed by Notified Bodies after the MDR DoA; only MDR certificates are able to be issued after MDR DoA [MDR Article 120 (1)].
- Prepare for MDR-Compliance – Manufacturers are required to create MDR-compliant documentation, e.g., Declaration of Conformity, Technical Documentation, Summary of Safety and Clinical Performance (class III or implantable), etc. to support self-certification and conformity assessments by a Notified Body before placing a MDR device on the market.
More Assistance and Information
Reed Tech provides valuable assistance and expertise in preparing for EU MDR/IVDR prior to the MDR DoA and through the two year EUDAMED delay. If you have questions on EU datasets and EUDAMED test submissions, contact us for more information. Email: MedDevice@ReedTech.com
For more on Unique Device Identification (UDI), visit the Knowledge Center