No pause on compliance11 May 2020
Eudamed, a database to monitor the safety and performance of devices, has been postponed by the European Commission until May 2022, which coincides with the implementation date for the In Vitro Diagnostics Regulation (EU IVDR). While the date for the Medical Devices Regulation (EU MDR) was intended to remain at May 2020, the coronavirus pandemic has led it to be delayed one year until 26 May 2021. Abi Millar finds out what is required to ensure compliance.
In late 2019, it emerged that Eudamed – the new medical devices database for the European market – was being delayed by two years. Originally set to launch in May 2020, the database will now become operational on 26 May 2022. This will give companies with Eudamed projects more time to prepare their systems. While the delay has been welcomed in some quarters, it isn’t as simple as sitting back and breathing a sigh of relief. Companies will still have to meet the May 2021 deadline for the Medical Device Regulation (EU MDR), which was pushed back a year due to the novel coronavirus pandemic in order to prevent the disruption of medical supplies. Though the specifics are open to interpretation, those basic facts are clear.
Eudamed2 comes into force.
The European Commission proposes new regulations on medical devices and in vitro diagnostics.
The European Commission names the four issuing agencies for UDIs.
The original launch date for the new Eudamed database.
The current date for the new Eudamed to start, after its postponement, now coinciding with the EU IVDR.
According to the European Commission, which recently updated its page on Eudamed, “The Commission concluded that it will only be possible to make Eudamed operational once the entire system and its different modules have achieved full functionality and have been subject to an independent audit. Therefore, Eudamed’s launch will be done together for medical and in-vitro medical devices, at the original date foreseen for in-vitro medical devices – that is, May 2022.”
The delay to MDR has given a bit of breathing room for businesses, but preparations will still need to be made sooner rather than later. Although you may not be able to upload documents into Eudamed, you should still prepare these documents as the MDR requires. The In Vitro Diagnostics Regulation (EU IVDR) is also unaffected by the change, since its implementation date was always scheduled for May 2022. The only difference is that it’ll now coincide with Eudamed.
The number of individual organisations that will be involved in the new Eudamed, according to the latest estimates.
Origins of the database
What this actually means in practice may require some unpacking. To understand what Eudamed and the MDR are all about, it’s worth going back to 2012, when the European Commission proposed new regulations on medical devices and in vitro diagnostics.
Prior to that point, medical device regulations had remained unchanged for two decades, and the Medical Devices Directive (MDD) had begun to seem past its best. It hadn’t kept pace with the fast-evolving nature of medical devices, not least the arrival of software as a medical device (SaMD). There had also been a number of highprofile safety incidents (such as hip replacement recalls and the ruptured breast implant crisis) that highlighted the need for regulatory reform.
The new regulations should stand to improve the safety and transparency of the medical devices landscape. To take just one example, all medical devices will now need to undergo an independent safety and performance assessment before they can be marketed in the EU. What’s more, the manufacturer’s responsibility doesn’t stop once the device has been approved. Compared with the MDD, the EU MDR is less focused on the pre-approval stage and more on the entire life cycle of the product.
Another big change is the fact all medical devices will need to be assigned a unique device identification (UDI) code at the individual item level. The code will be applied to the label, the packaging and in some cases the device itself. This will enable full traceability for all devices sold throughout the region.
In June 2019, the European Commission named four issuing agencies for the UDIs. These are Informationsstelle fur Arzneispezialitaten, the Health Industry Business Communications Council, ICCBA and GS1. All of these (aside from Informationsstelle fur Arzneispezialitaten) also have accreditation to assign UDIs in the US – a big step towards global standardisation.
“GS1, an international standards organisation, has been accredited as an issuing agency for UDI in Europe and will support the EU regulators in ensuring the successful implementation of the UDI system as defined by the EU Medical Device and In-Vitro Medical Device regulations,” says Ulrike Kreysa, senior vicepresident of healthcare at GS1. “Global GS1 standards will enable manufacturers to comply with these requirements, which will enter into force in [May 2021]. By using GS1 standards, manufacturers will be able to create and maintain compliant UDIs in Europe, but also in other countries in the world like in the US, China, Korea and Turkey.”
She adds that the GS1 global system of standards is the most widely implemented in the world, and is used by all stakeholders in healthcare supply chains. “The GS1 identifiers are fundamental to enable an efficient and effective identification of medical devices from product conception through every step of the supply chain life cycle,” she says. “Improving patient safety is central to GS1 Healthcare’s mission and GS1 is committed to supporting stakeholders across the world in implementing UDI systems – in Europe and beyond.”
As to where Eudamed comes into this, devices that fall under Class IIa/b and Class III will need to have their UDI recorded and indexed into the Eudamed database. One of several databases introduced in the MDR, Eudamed will allow manufacturers, consumers, regulators and other interested parties to access the latest data on European medical devices. It will also include information about clinical investigations, post-market surveillance and many other areas.
An ambitious step forward
The new database will have several advantages over the existing Eudamed2, which came into force in 2011. That database, which acts as a central repository for market surveillance information, is only accessible to the European Commission and the national competent authorities. Since it can’t be accessed by other groups, medical device companies can’t verify their data or check how that data is represented. There have been problems with accuracy, as well as double entries and missing information.
The new Eudamed is a far more ambitious project. The latest estimates suggest it will be open to over 70,000 individual organisations, resulting in over 300,000 actual users. There will also be a public site, meaning the public will be able to research the latest data and make informed decisions before going ahead with procedures.
There’s a lot to do from an IT perspective. According to Eudamed.eu (a company established to assist organisations with Eudamed), the European Commission has a number of challenges on its hands.
The estimated number of actual users for the new Eudamed.
“Firstly, the EC has to prepare a robust application to cover all stakeholder and legislative requirements,” the company’s website reads. “They must also provide machine-to-machine data transfer capabilities, meaning medical device companies (after successfully registering) will be able to upload all the required data automatically to the EC system. This is not a small task.”
Although the European Commission hasn’t gone into much detail about the reasons for the Eudamed delay, it’s easy to see why these kinds of tasks might have taken longer than expected.
Of course, the delay won’t just buy time for the European Commission. It’ll also give medical device manufacturers more time to prepare. Richard Houlihan, the CEO of Eudamed.eu, has described the delay as a “nice surprise”.
“This is a real positive for the industry. Companies, with regard to their MDR Eudamed projects, should view this delay as an opportunity,” he said in a social media posting. “The industry representatives at the working groups have constantly stated that companies need 18 months from receipt of final specifications to prepare their systems. This delay gives that time.”
He pointed out, however, that there was no reason for companies to slow down or postpone projects, especially since there is a tendency to underestimate these projects’ complexity. This is broadly in line with advice given elsewhere. The consensus seems to be that manufacturers should keep moving forward in gaining expertise and preparing their submissions.
Some uncertainty ahead
At the time of writing, neither the European Commission nor the Medical Device Co-ordination Group (MDCG), which assists the Commission, have provided official guidance. The latest version of their rolling guidance plan reads, “Group yet to be established under MDCG; the Eudamed group will not issue guidance”.
One expert approached for this article said he was limiting his communication on Eudamed for the time being, as there are too many uncertainties. He hoped the situation would become clearer following an upcoming MDCG meeting, adding that “clients with UDI questions that cannot wait are recommended to be sensible”.
What ‘being sensible’ means will depend on the specifics of your project, but it is unlikely to mean shelving your current Eudamed plans. And it definitely doesn’t mean ignoring the new MDR deadline. With clearer guidance pending, it’s probably best to press ahead as usual and work out what you can stand to gain from those additional two years.
Eudamed2 - European databank on medical devices
Eudamed2 is the European databank on medical devices. Its purpose is to strengthen market surveillance and transparency in the field of medical devices, by providing national competent authorities with fast access to information. It also contributes to a uniform application of the directives.
Which information is stored in Eudamed2?
Depending on the applicable directive, Eudamed2 contains data:
- on registration of manufacturers, authorised representatives and devices
- relating to certificates issued, modified, supplemented, suspended, withdrawn or refused
- obtained in accordance with the Medical Device Vigilance System
- on clinical investigations.
Who can access Eudamed2?
Eudamed2 is a secure, web-based portal, which serves as a central repository for information exchanged between national competent authorities and the Commission, and is not publicly accessible. Its use has been obligatory since May 2011. The operational functioning and the added value of the databank have been evaluated and the Eudamed2 evaluation (380kB) results are publicly available.
Source: European Commission