The EU MDR 2017/745 establishes an EU database to enhance overall transparency related to economic operator, registration, clinical investigation, vigilance, market surveillance reporting by the deadline of November 26, 2022. The EUDAMED database will cover all finished good medical devices and only excludes custom-made devices from data entry.
The new regulations on medical devices (EU MDR) and on in vitro diagnostic medical devices (IVDR) establish a much wider EUDAMED database than the existing one under the current directives (Eudamed2). Currently, the EC database on medical devices, Eudamed2, is a secure web-based portal. It is a central repository for information on market surveillance exchanged between national competent authorities and the Commission. Its use is restricted to national competent authorities, it is not open for consultation and is not publicly accessible.
However, the new medical devices regulations (EU MDR) contain important improvements including a much larger EUDAMED database. The new EUDAMED will be multipurpose. It will function as a registration system, a collaborative system, a notification system, a dissemination system (open to the public), and will be interoperable.
Commission’s Present Situation on The Implementation of The EUDAMED Database
The European Commission is delaying the launch of Eudamed for both medical devices and in-vitro diagnostics to May 2022, it was confirmed recently that Eudamed cannot be made operational until the entire system and its different modules have achieved full functionality and are subject to an independent audit. The date of application of MDR still remains May 2020, which effectively means that device manufacturers can postpone their entering of data into the Eudamed database.
Structure of New Eudamed:
As per Functional specifications for the European Database on Medical Devices, first draft version the 4.1, MDR Eudamed Information system would consist of two components.
The public site of Eudamed will have part of the information to be publicly accessible, it is not clear, what exact information will be available and accessible to the public. Restricted site of Eudamed, grants access to different modules and it has role-organization based access, which means a display of the information or modules will be customized by user roles and actor types. As connectivity is concerned with national and economic operators’ systems allows the export of the data from the central database to a local database. It also offers bulk upload functionality for economic operators and notified bodies. Decentralized user administration will allow actors to manage their own users.
The below table outlines the additional information requiring submission into Eudamed database as per annex VI.
|Economic Operator||Contact information and SRN for manufacturer, authorized representative, or importer/distributor|
|Regulatory Contact||Company regulatory representative or third-party submitter in charge of submission|
|Unique Device Identifier (UDI)||Basic UDI-DI; May also need to include UDI-PI (the production identifier) in the form of an expiration date, manufacturing date, lot number, or serial number; Basic UDI-DI shall appear on the Declaration of Conformity|
|Regulatory approval details||Includes the approval certificate number and Notified Body details|
|Country availability||Member State where device will be placed on the market in the EU (availability for class IIa, IIb, and III devices)|
|Device risk classification||I, IIa, IIb, III|
|Single use Notice||Denote if device is a reprocessed single use device (labeled as single use device or list maximum number of reuses).|
|Drugs/Possible Contaminants||Presence of medicinal drug/product, human blood/plasma derivative, tissues/cells of human/animal origins, latex, or phthalates|
|Clinical Investigation||Identification number of clinical investigation(s), if applicable|
|Intended purpose||Intended purpose if other than medical|
|Public statement on safety||Summary of safety and clinical performances (class III or implantable devices only)|
|Device status||On the market, no longer placed on the market, recalled, field safety corrective action details, or other|
|Quantity||Quantity per package|
|Medical Device Nomenclature Code||Internationally recognized medical devices nomenclature is available free of charge and made available by the EU regulatory commission – Italy’s National Classification of Medical Devices (CND) mapped to Global Medical Device Nomenclature (GMDN) codes|
|Product Identification||Product trade name, description, and number (catalogue/reference code)|
|Clinical Product Size||Volume, length, diameter, or other measurement|
|Storage and Handling Condition||Details on how the device should be stored and handled|
|Sterility||Details on sterility or need for sterilization prior to use|
|Electronic IFU||URL for additional information such as eIFU (optional)|
|Vital Safety Information||Critical warnings, precautions, or contra-indications, if applicable|
The new Eudamed database is much larger than the existing Eudamed2 database. With extended timelines of Eudamed implementation, it will be interesting for manufacturers to go through the transition period after EU MDR comes into the effect in May 2021 and to be prepared for the Eudamed launch.
Myth: The EC will reverse its decision not to use GMDN codes.
Myth: The EC is going to provide us with all the support we need, our IT teams can just contact them.
Myth: We can apply to our Competent Authority in advance for a SRN.
Myth: The SRN will be the same format as our VAT number.
Length 15 characters
Format: ISO Country Code-Actor Type-9 digits
Actor type example: Manufacturer: MF, Importer: IM
Full code: IE-MF-000000001
One of the greatest, time sensitive, bottlenecks was always going to be actor registration. Under the initial March 2020 go-live plan, competent authorities (CA) were always going to be under severe pressure to complete validations.
The main benefit is the manufacturers, system / procedure pack producers, authorized representatives, and importers, will be able to register and receive their SRN well in advance of the May 2022 deadline. They will be under no pressure to get the SRN, required to be able to get their devices and vigilance issues registered in Eudamed. The EO’s will be able to register, and wait with no time pressures, comfortable in the knowledge the CA’s are working on their registration validation.
This is even better news for the Non-EU manufacturers who were even more disadvantaged with registration process. Non-EU manufacturers could not register until their authorized representative had completed their registration. A non-EU manufacturer has a double validation, firstly by their authorized representative and secondly by the CA.
The EUDAMED is just one examples of many new demands being placed by the new European Medical Device Regulation. It can be difficult to make sense of it all but there are ways we can help.
We’d be glad to help!!
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