The European Database for Medical Devices, or Eudamed, contains data on medical devices that have been collected and entered by Competent Authorities and the European Commission and can only be accessed by these same parties.

In the proposals for Regulations for medical devices and in-vitro diagnostics, a completely new version of Eudamed is proposed. This ‘MDR Eudamed’ is intended to provide more data, of higher quality and with a wider accessibility. In January of 2016 the European Commission hosted the first meeting of the ‘Future Eudamed Steering Committee.’ The Steering Committee exists of experts representing future users of the MDR Eudamed and is intended to provide a forum that can reflect on obstacles and solutions.

A databank with ‘everything’ for ‘everyone’…

The MDR Eudamed will not only be used by the National Competent Authorities (NCAs) and the European Commission. It will also be accessed by:

• Medical Devices Coordination Group (MDCG);
• Notified Bodies (NBs);
• Economic Operators (EOs - manufacturers, authorised representatives, importers, sponsors);
• Experts;
• Non-European Competent Authorities;
• And the public, including medical institutions and the press.

Depending on the type of user, only certain levels of the databank can be accessed. The end result should be that there is more transparency in what medical devices are distributed where and who is responsible for them.

The types of data in the current Eudamed are limited to Actors (NCA’s, EOs, NB’s), devices, incidents (NCARs), certificates and clinical investigations. The MDR Eudamed will also have:

• Unique Device Identifiers (UDI) and depending on how this will be organised Eudamed may issue a Device Identification in parallel;
• Economic Operators will be identified by a Single Registration Number (SRN);
• NB accreditation and designation (currently in Nando);
• Extended vigilance data, including post-market surveillance;
• Applications for conformity assessment by NB’s;
• Summaries of safety and clinical performance (new in the MDR);
• Performance studies for IVD’s, similar to clinical investigations;
• Market surveillance data.

Current users can register data and search Eudamed. They can download files and generate statistical reports. The MDR Eudamed will also allow other forms of reporting, and will be multilingual and allow for data exchange through web services. Last but not least, artificial intelligence will be used to monitor the quality of uploaded data, to analyse and report, and to create alerts.

Big challenges

The MDR Eudamed will be the engine driving the new Regulations. The system must be ready in time and then it must have the high level of quality and security required for its enormous task. If Eudamed fails, the new Regulations will fail. This puts serious pressure on the project. It appears this has been understood by the European Commission, who allowed for a fair budget and a high priority for this project.

But some of these challenges cannot be solved by budget alone. There are also political issues. For example, the system must allow for multilingual operation. Data fields with limited options can be made accessible in different languages, but free fields may cause problems. Member States will have to accept a ‘single language’ Eudamed up to some level in order to make it work. It is up to political decision making where this level will be.

Other challenges are:

• UDI needs to be unambiguous on what it is and identifies and it should be aligned with the current FDA UDI;
• Nomenclature and classification of events must be unambiguous and functional;
• The sheer number of users will require robust technology: 25,000 European manufacturers, possibly a similar number from outside the EU;
• There may be a million devices to be entered into Eudamed, with many mutations on a single day;
• Older versions of most of the records must be kept in Eudamed. This means that the total number of records will always be growing.

Timeline

Currently the European Commission expects the Regulations to be adopted in September 2016. This should not be considered a hard fact. The development team had to make a planning and consider a starting date. This is the best they have at this moment; it is not likely the Regulations will be adopted earlier, if they are adopted later this creates extra room in the planning. And in the case there is no agreement on the MDR, the project will be cancelled.

There is a three-year transition period for the MDR. The IVD Regulation may have a five-year transition period and is therefore less critical. The development team aims at finishing the project halfway the transition period to allow for extensive testing and early introduction to the stakeholders. Once the Regulation has become effective there is a 1.5-year period for manufacturers to comply.

So the MDR Eudamed may be ready for beta-testing by March 2018, operational by March 2019, formally functional in September 2019 and existing data entry will continue into March 2021. This may look like a long way away, but for the development team and the stakeholders represented in the Steering Committee this means that a lot of work has to be done now. Emergo will be in thick of this and through this blog you will be kept informed.

For additional information on European regulatory changes, see our whitepaper. A video overview of the European CE Marking process is also available.

Ronald Boumans is Senior Global Regulatory Consultant at Emergo. He serves as member of the Future Eudamed Steering Committee on behalf of Emergo and represents the European Association of Authorised Representatives.