An initiative that is expected to eventually create a more reliable global marketplace and reduce the presence of illegal medical devices or in vitro diagnostics (IVDs) could inherently, albeit not intentionally, be precluding manufacturers from achieving compliance.

Despite previous delays, the European Union (EU) continues to move closer to setting a deadline for the formal implementation of the European Database on Medical Devices (EUDAMED), the information technology (IT) system that is intended to serve as the central regulatory database for medical devices and IVDs throughout the EU.

Established in 2010 by the European Commission (EC) through its Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), EUDAMED’s protocols haven’t necessarily followed a linear path in defining the criteria for satisfying product registration compliance.

Initially expected to be fully functional by July 1, 2025, as a replacement for the Medical Device Directive (MDD) created in 1993, EUDAMED is now essentially operating on a wait-and-see approach as stakeholders await notice of its status to be published in the Official Journal of the European Union (OJEU).

From that point, full compliance will become mandatory 6 months later, according to Dr. Oliver Eikenberg, PhD, quality assurance/regulatory affairs manager at Pure Global, an artificial intelligence (AI) and data-powered life sciences services provider based in Jersey City, NJ, that specializes in regulatory consulting for medical device and in vitro diagnostics (IVD) companies.

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“The expectation is that it will be published soon and that EUDAMED compliance will be mandatory at the beginning of next year,” he said. “That’s the timeline. And this is what is bringing a specific pressure to manufacturers to enter into EUDAMED before they realize that they don’t have the data or the resources – and that could lead to panic.”

As of May, EUDAMED is also transitioning to a phased implementation model instead of the previous approach of a module-by-module activation system.

With many manufacturers located outside of the EU assuming that EUDAMED is a local requirement that’s relevant only to EU-based companies, Dr. Eikenberg is urging industry leaders to avoid a costly misconception and to recognize that EUDAMED applies to all medical device and IVD manufacturers who want access to the EU market, regardless of where the company is based.

Delaying action on the industry side will increase the risks of bottlenecks, resource strain, and disrupted market access, while those that adapt as early as possible will see better opportunities for streamlining compliance, gaining regulatory confidence, and positioning themselves competitively within the EU market.

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MD+DI recently spoke with Dr. Eikenberg to gain insights into how earlier EUDAMED registration can lead to long-term operational and reputational gains, operational resilience, and a need to rush to compliance.

Why is there confusion throughout the industry today related to EUDAMED and whether or not it is applicable to all medical device and IVD manufacturers who want to access the EU market?

Eikenberg: This is a very important topic that we’re raising because it has been silent for too long. Based on the final steps to implementation, there’s more pressure on manufacturers and on all stakeholder parties who are required to register within EUDAMED. Although the idea of the EUDAMED system can be found in older directives, we did not have all of the IT elements available that we do today. So that is why the EUDAMED system was never completed.
The European member states have their own databases, and the input information is slightly different based on international laws. This creates some hurdles. Typically, if you are registered in one European country, you do not necessarily need to register for most devices in the other countries.

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But, for reasons such as reimbursement issues, some types of devices would need to be registered for different European member states. And this all has created a lot of confusion. And it has raised a lot of questions based on the classification of some devices based on the way they should be marketed.

This is not a fit for the future because we want to have one central system, similar to other countries, if we are to consider Europe as one nation. What this means is that all of the differences that exist between the national European member states’ legislation should disappear in the coming years, and everything will be registered into EUDAMED.

This has been the idea for several years, although it has not yet become mandatory. But we’ve now turned into a more mandatory phase. Why? The reason is very simple. Because every type of system and every type of software must be validated before it’s functional.
As of 2017, we are now moving to the EUDAMED system, which is now under the MDR and IVDR.

Manufacturers who are compliant with the regulations have a strong benefit. You need to have a Single Registration Number (SRN), you need to have a Unique Device Identification. If you don’t, you will not get a CE certificate.

Why do you think there is some confusion and misconceptions about the timeline and compliance?

Eikenberg: As an assumption, I believe that many manufacturers are not fully tracking all the updates and timelines that are made available by the medical device coordination working groups and being published by the EC.

And they have seen over time that this has all been frequently delayed. Some organizations might not have realized that this is really ready to become mandatory. They may believe that the member states’ regulations will still be sufficient, especially for legacy devices.

But it’s important to understand that this is a changing system and that this is a new system. Under EUDAMED, the system will be more accurate, be more precise, and be aligned with the MDR and the IVDR.

What are the modules that make up the EUDAMED system?

Eikenberg: There are six different modules: Actor Registration, Device Registration, Notified Bodies and Certificates, Clinical Investigations and Performance Studies, and Market Surveillance.

The initial idea was to get EUDAMED functional with all models as a total system. Over the years, the regulations have changed in a way that separate modules are audited.

What are examples of the types of responsibilities that manufacturers currently have, and what should they act on?

Eikenberg: My strong recommendation is to check your data and provide as much data as you can. The manufacturer has the sole responsibility to enter device data. There needs to be a significant change in awareness that this is not done by the EUDAMED system. This information is also collected under MDR and IVDR requirements, not under MDD and IVDD, which are old and imprecise documents.

And this is version-controlled, which means auditors can track information that is entered today at some other time in the future. They can identify specific categories of devices to see if there’s consistent information being entered. For example, information that is public on a website can be tracked to see if the information being entered into the EUDAMED system is consistent and complete. If it’s not, that will raise questions in the EUDAMED system that can be filtered and can be the focus of information that’s automatically tracked.

Everyone needs to think from the perspective of agencies and surveillance. There are surveillance tasks to identify risky devices or noncompliant devices. Those who are not entering consistent information will be tracked and identified.

This is why I recommend that manufacturers check their data, go to the EUDAMED system, and enter it. If you have questions, ask a consultant for assistance. By making sure this information is aligned, you reduce your business risk if you receive requests from the National Competent Authorities.

What’s the basic level of awareness that industry stakeholders need to have today with their processes regarding EUDAMED?

Eikenberg: You need to have a quality management process in place for EUDAMED. And this is not a simple recommendation. It’s an obligation to have this. And the European MDR and IVDR require this.

You need to have a EUDAMED process in your quality management system so that you can define: Who’s responsible for tasks and how will they be done? Are you tracking the EUDAMED updates from the EC? What will change for your type of device with the National Competent Authority?

If you don’t have somebody designated, you first need to define the responsibilities. And the appointed person then needs to align all content with information from the technical documentation. This is also version-controlled, so the content can be saved during this transitional period.

The first tracking from EUDAMED is expected to be done on the manufacturers who are not registered. They will first identify if the manufacturer information is matching with, for example, the EC representative data or other importer data.

There are videos and explanations available on the EC website on how to start the device registration.

What defines where stakeholders need to be with registration currently in the context of EUDAMED policies?

Eikenberg: There are two scenarios: 1) If you have currently registered in one of the member states, and in these databases, it’s still voluntary to use or to start with the active registration and the device registration that would become mandatory next year. 2) If you have not yet registered in any member states, I strongly recommend to not do that at this time and instead directly using the EUDAMED system. Because this is the only place where you will have evidence of a registration.
In the first scenario, you must also then make sure that at a specific point when you perform the EUDAMED registration that you de-register in the national databases. You should delete this registration when your actual registration ends, and device registration becomes active.

What is the overall concern currently about the potential for bottlenecks, and is there anything that can be done to potentially alleviate the threat?

Eikenberg: We have seen in the past with other deadlines that as this deadline approaches, activity significantly increases because many people are attempting to enter data before the deadline. That’s why I simply recommend to move ahead now and to not wait until the end of the year.

Every system requires a specific learning curve until there is more familiarity. So, get familiar with this. Get familiar with the information so that you have some time. If you wait until the deadline, you will experience more pressure, which could then lead to errors. And ask your questions now. There’s also a help desk.
If problems arise after you should have submitted something, or after a specific date would have passed, it might be more complex or might not be accepted due to noncompliance. Nobody knows at the moment what will happen, but that’s why waiting is not recommended.

What do you see as some of the more time-intensive tasks?

Eikenberg: In my view, it depends on how many devices you have. For example, some companies have very extensive catalogs of devices and device numbers. Of course, the more devices you have, the more time-consuming it might be to bring them all in.

There are some third-party companies that have specific software doing this type of work automatically, and this is a specific service that typically is not inexpensive. It really depends on if the company wants to invest in this type of service or not. It depends on if you have a small category of devices or if you have a longer list of devices.

And you can leave out any information that you still do not have, but you should keep notes for information to be clarified at a later point. It’s better to have entered 80% or 90% now instead of leaving out everything.

What do you see as the impact on future business operations, and what do you see as the overall changes that this system is going to have on industry?

Eikenberg: I believe that we will see much stronger market surveillance to identify non-compliant and illegal devices. From the patient’s perspective, it is a significant value, and it will add transparency. This might also then be linked with customs.