October 4, 2019
Last month, AssurX hosted a webinar entitled “Who Moved my MDR? Assessing Organizational Readiness” with Richard Houlihan, CEO of Eudemed.eu and leading consultant and international speaker on MDR technical management. We discussed the EUDAMED registration process, quality standards, and design control, and how organizational data needs to be submitted for a smooth registration process. EU MDR reinforces that electronic data and documentation will significantly change the type, quality, quantity, and accessibility required for compliance.
Below are the 10 most common questions from the webinar:
1. What is EUDAMED?
The European database on medical devices (EUDAMED) is a secure web-based portal. It is a central repository for information on market surveillance exchanged between competent national authorities and the Commission. Its use is restricted to competent national authorities; it is not open for consultation and is not publicly accessible. EUDAMED is the core of MDR. It will go live on March 26, 2020.
2. When should we register for EUDAMED?
Prepare for a slow process. 80,000 companies are expected to request logins to register. If a company has more than one role, e.g., manufacturer, importer, and distributor, it will need multiple registration applications.
Companies are advised to obtain an EU login before the March 26 deadline. Applications will be taken in the order received. Please keep in mind companies outside the EU must also be validated by a competent authority, which may be different from the one they have worked within the past.
3. What’s the best way to upload data into EUDAMED?
There are three ways of getting data into EUDAMED; a web interface, bulk upload, or machine-to-machine (M2M) data exchange.
The web interface is best for a company with maybe one or two products because it is a web interface that can be several pages long, with approximately 70 elements of data to provide. The fields have to be manually entered, which makes the system prone to error. For companies with more than a handful of devices and/or extensive data, this is not a realistic approach to MDR data management. The web interface might be better suited for limited updates after the majority of data have already been uploaded to the site using bulk upload or a machine-to-machine (M2M) data exchange.
Bulk upload or M2M options are the best options for organizations with multiple products. Both of these require XML, and there is quite a bit of complexity in putting those data uploads together. Keep in mind, XML has its specific validation form in addition to business rules. It needs to be set up correctly, which can be a resource-heavy undertaking. It will likely require consultation with a third-party vendor.
Another essential aspect to remember is that EUDAMED data will be public. Although we don’t know the level of public access or how quickly it will be available, it is assumed that within 12 hours of upload, most of the data will be publicly available. Therefore, anything uploaded requires close attention to detail and irreproachable accuracy.
4. What about products already in the MDD (legacy devices)?
There are no exceptions. Legacy devices on the market after the MDR application date must be in EUDAMED. Companies will have an 18-month window to add devices after the application date (by November 2021). However, if there is a vigilance issue or the item is put on the market after March 26, 2020, then the data must be entered immediately. For example, a Manufacturer Incident Report (MIR) form cannot be submitted without the device being in EUDAMED. Get your data prepared as part of EU MDR data management best practices so it can be added immediately after you receive an SRN (Single Registration Number).
5. What is required to maintain devices in EUDAMED?
Although the initial upload into EUDAMED is extensive, maintenance is relatively minimal, depending on the product and quality/regulatory vigilance. Changes to packaging, market expansion, and post-market updates will all require updates. After two (2) years, companies must update to show the device is still on the market. These changes and updates can be managed with smaller uploads or directly via the web interface.
6. Is there a difference between the FDA’s UDI and the EU UDI?
Although UDI system requirements are following the principles laid down in the IMDRF UDI guidance, there are a number of differences between the two systems. A complete breakdown of these discrepancies can be found at MedtechEurope.org.
One significant note is that the UDI nomenclature features guidance from the Medical Device Coordination Group (MDCG), not the Global Medical Device Nomenclature (GMDN), which was the guidance preferred by the United States. MDCG plans to use Italy’s Classificazione Nazionale Dispositivi Medici (CND) codes as the basis for the EUDAMED device database nomenclature. GMDN was unable to provide guidance information free of charge to the industry. At this time, any rumors that GMDN will be back in again are not reliable. However, CND codes will be mapped to GMDN for ease of use.
7. When should I worry about UDIs for products within MDD during the “gray period” between May 2020 and May 2024?
The labeling requirement for MDR is exact: the UDI must be there. However, there is no exact deadline as to when to have the UDI on the MDD labels because it was not a requirement in MDD. A best practice in all aspects of EU MDR data management is to get your master data in place as soon as possible.
8. When is the SSCP required to be submitted?
Summary of Safety and Clinical Performance Report (SSCP) is applicable for High-Risk devices (Class III and implantable devices). The initial (draft) submission goes to the Notified Body for validation and uploading to EUDAMED, so the answer depends on your product. The SSCP report is a public document that should include labeling and instructions.
9. If a manufacturer has different manufacturing sites, can multiple sites obtain a single SRN, or does each site require its SRN?
Different sites do not require separate registrations, only different entities or legal companies.
10. From a QMS standpoint – what do I need to be concerned about?
From an organizational perspective, knowing where your design control processes are and how they are implemented is essential. Ensuring that your R&D and clinical systems can electronically access that information is crucial. Many times, this is still documented on paper, and it will quickly get complicated when you start talking about bulk uploads, and XML uploads from machine-to-machine. The more manual effort in the process, the less efficiency, which is best resolved with an integrated, modern QMS solution. Looking at QMS through the EU MDR data management lens, only a fully integrated QMS system will streamline the data, and it will be more factual to present the process and IT data to management.
Conclusion
It is critical to focus on EU MDR regulation itself and what is required. Nevertheless, don’t lose sight of what your organization needs to comprehend the regulation and execute the requirements (i.e., EU MDR data management). Be familiar with the timelines and plan appropriately, so there is sufficient prep time for the necessary IT changes and enhancements to meet EU digital expectations.
AssurX continues to connect with industry experts and prepare our customers for EU MDR. More directives are anticipated to impact how businesses will get their products to market and keep them in the market.
