Part 7 in a 7-part series on the EU’s Medical Device Regulation
The European Database for Medical Devices (EUDAMED) was conceived 20 years ago in 1998, originally as part of the In Vitro Diagnostics Devices Directive (IVDD) and included the Medical Devices Directive (MDD).
Under the new MDR that replaces the MDD, the European Commission recognized that to fully support the more stringent requirements for filing, reporting, and continuing surveillance, it would need to greatly expand the capabilities of the database for monitoring and data collection.
EUDAMED beefed up to support MDR
The redesigned system is expected to go live in March 2020 and is intended to consist of seven databases that will track:
- Economic operators
- Unique Device Identification (UDI)
- CE marking
- Quality Certifications
- Clinical and performance studies
- Vigilance data and market surveillance
By comparison to the FDA’s searchable database MAUDE, the EUDAMED2 as it is being referred to by the EU Commission, is expected to be much more complex.
EUDAMED has been processing device, certificates, NCARs (National Competent Authority Reports), and clinical investigations data since 2011.
The EUDAMED2 is the engine driving the new MDR and expands the list of users to members of the Medical Devices Coordination Group, Notified Bodies, Economic Operators (manufacturers, authorized representative, importers, and sponsors), Experts, Non-European Competent Authorities, and the public including medical institutions and the media.
Device makers required to register for EUDAMED2
Under Article 10 General Obligations of Manufacturers, if you are a medical device maker seeking to sell your products in the European Union, you must register with EUDAMED2, pass Competent Authority validation, and then provide device-specific data, UDIs, packaging, OEM, and much more to MDR EUDAMED.
Until the go-live in May 2020, device makers will need to prepare their data for inclusion in the EUDAMED2 database.
There are specific requirements for data entered into EUDAMED2 that may require significant effort and resources with which to comply. For example, Under Article 27 Unique Device Identification System there are extensive requirements, such as, the material needed for a UDI must include identifier information specific to the manufacturer and the device.
Another challenge EUDAMED2 poses is that you will need to decide how to provide your data to EUDAMED. You can provide the data manually, via XML upload, or via machine-to machine (M2M) exchange. Each method has additional complexities that will need to be considered.
Internationally Harmonized Nomenclature
According to Article 26, to facilitate the functioning of EUDAMED2, an internationally recognized medical device nomenclature should be available free of charge to manufacturers and other natural or legal persons required by this Regulation to use that nomenclature. Guidance for nomenclature requirements is available on the European Commission website (MDCG 2018-2).
Under the law, the European Commission has mandated that names and codes be publicly available in the UDI database in EUDAMED2, be free of charge, and be internationally recognized at the time of the date of application of the Regulations.
Maintenance of this work has been over by the GMDN (Global Medical Device Nomenclature) Maintenance Agency, which further developed the nomenclature and will review, determine, and validate rules. The goal is to ensure that the web-based nomenclature system will be regularly updated and will adequately support the functioning of the EUDAMED2 database, support the functioning of the new Regulations as a whole, and remain accessible to manufacturers.
Before your data submission is accepted into EUDAMED2, your Competent Authority will validate that your data is correct and accurate. Then, your organization will need to add and manage your EUDAMED2 users, how many staff will have access, what information they will be allowed to access, and whether they have rights for editing, adding, uploading, and versioning your organization’s data.
If you are looking for help with how the EU’s MDR affects your organization, Kapstone Medical has the experience and expertise to assess your product portfolio, quality management system procedures, and design history files. Contact us for more information.
Sources: Euro-Lex Document 32017R0746; European Commission Medical Devices, Current Directives