The speculation on EUDAMED timing has been addressed by the European Commission’s (EC) announcement on 30 October 2019 that EUDAMED will be delayed two years from the original date of 26 May 2020 to 26 May 2022. Download EUDAMED Delay Fact Sheet from Reed Tech.
The EUDAMED launch on May 2022 will support both Medical Devices and In-vitro Diagnostic Devices. In addition, the EC confirmed that the Date of Application (DoA) of the Medical Device Regulation (MDR) will remain unchanged at 26 May 2020. With this in mind, there are certification processes required for MDR that are not delayed and need supporting documentation and product data, including Basic UDI-DI. Continued diligence in implementing EU UDI should remain a priority as internal needs and future EUDAMED reporting drive the need for accurate UDI data availability.
Both providers and manufacturers should continue to move forward in testing, gaining expertise and preparing submissions. Reed Tech is continuing EU EUDAMED testing and our clients are being supported in their preparation and test submissions as EUDAMED is available.
We have successfully performed submission tests with 1,500+ records to date (associated with 15 Basic-UDIs with over 100 UDI-DI devices each). The EC has not closed EUDAMED testing and in fact, initiated the second round of EUDAMED testing in early November 2019, after the EUDAMED delay announcement.
1. What Implications Need Attention During the Delay
MDR requirements, other than EUDAMED reporting, come into force on the DoA, 26 May 2020. Numerous 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 UDID-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.
If you haven’t started EU preparation, accept the break and use this time to your advantage! Transitioning to EU MDR/IVDR is a huge task and will require time and effort. There are multiple EU MDR/IVDR implementation steps including: understanding the regulations, determining your requirements, identify your gaps, creating/executing a plan, preparing procedures/data/systems, preparing MDR documentation, engaging a Notified Body and securing assessment approvals, registering your organization and devices, updating labels, etc.
2. How can Reed Tech Help in EU MDR/IVDR Preparation during the Delay?
Reed Tech provides valuable help in preparing for EU MDR/IVDR prior to the MDR DoA and through the two year EUDAMED delay.
- Guidance and Expertise – to help you shape your UDI data management strategy for EU, FDA, other regulators, and business partners worldwide
- Training – to assist your understanding of the EU datasets
- Multiple datasets for MDR devices, MDR SPPP, and Legacy MDD devices
- Two-level hierarchal structure for Basic UDI-DI “model group” attributes and UDI-DI device attributes
- Large number of attributes, over 100 EU attributes compared to 64 FDA attributes
- Unique EU attributes with almost all differing from the FDA GUDID dataset
- Data Collection Tools – to allow you to collect EUDAMED data and discover gaps efficiently via Reed Tech data templates
- System Test Environment – to exercise and verify successful data transfer and import functionality from your system to the Reed Tech system
- Data Cleansing Platform – to support your early efforts in ensuring your data meets the EUDAMED data validation rules
- Structured UDI Repository – to manage, control, and store your UDI values and attributes in a secure environment from inception to support:
- Assignment of BUDI-DI for MDR documentation and device assessment
- Collection of BUDI-DI, UDI-DI, and corresponding attributes for business activities, including MDR Class III Labeling requirements
- EUDAMED Test Submissions – to support your EUDAMED testing when EC opens up EUDAMED to public testing
- Global UDI System – to support your compliance preparation with emerging global regulators in parallel with the EU regulations
Looking beyond EU UDI, Reed Tech continues to work on UDI solutions supporting additional global regulatory requirements (e.g., South Korea, Saudi Arabia, China and others.) Contact us for more information and explore how Reed Tech can help you meet your global Medical Device UDI data management challenges and requirements.
- Official Statement: EC Notice of MDR EUDAMED Delay
- The MDR includes a section [Article 123(3)(d)] that addresses the situation of EUDAMED being delayed.