New Approach Outline for the Continued Development of EUDAMED
On Friday, March 13th, the Medical Device Coordination Group (MCDG) published a new guidance document titled: ‘Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR)’. In quoting the document, “This paper sets out a joint Commission and Member States plan, including concrete priority and contingency actions which are considered essential in order to have an operational system in place by May 2020. Contributions and calls from stakeholders have been considered.”
The document goes on to describe the plan for EUDAMED development and availability. Specifically, it states that “the development of EUDAMED will continue based on the functional specifications made public in March 2019. Following the release of the actor module by 26 May 2020, Commission services will continue finalizing the first set of modules, i.e. UDI/devices registration, the notified bodies and certificates modules, for subsequent deployment when functional.”
Reed Tech successfully completed all Feb 2020 Testing Scenarios …. More to come
At Reed Tech, this information does not come as a surprise, due to our ongoing active work on EUDAMED UDI Data Exchange Playground testing. Reed Tech has been able to successfully perform all test scenarios requested by the Commission. The latest round of testing concluded in February 2020 and included:
- Registration of MDR and IVDR Basic UDI-DI (Basic UDI-DI with UDI-DI)
- Registration of SPP (Systems & Procedure Packs)
- Adding new UDI-DI to existing Basic UDI-DI
- Updating Basic UDI-DI
- Updating UDI-DI
- Replacing marketing information previously submitted
In addition to performing the machine-to-machine tests, Reed Tech has been verifying results in the EUDAMED Playgound User Interface and reporting any unexpected behavior to the Commission.
Although the Commission has additional development to complete for the UDI module, including introducing additional priority features and addressing critical bugs, it is clear they are on a path to complete the UDI module in the not too distant future. Questions, however, remain regarding when and who will determine that the UDI module is functional, and how will it be deployed (pre-production, production, and other workflow concerns).
What should medical device manufacturers do now for EU UDI preparation?
MDR requirements, other than EUDAMED reporting, will come into force on the DoA, 26 May 2020. 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