Archive: EUDAMED ready to take IVD Information
EUDAMED looks ready to take IVD information when directive comes into force next yearEUDAMED, the European medical devices regulatory database, is now up and running and should be ready to receive information on in vitro diagnostics when the IVD Directive takes effect in June next year. There are also indications that the new nomenclature needed for IVDs will be ready in time.
This is good news for the IVD industry since, in the absence of a European database, manufacturers would have had to notify their product details separately to the competent authorities of each member state where their products are sold. The database provides a single point of entry for most products. With the database up and running, manufacturers will inform one member state, which will then be responsible for entering the details on the database. The competent authorities are optimistic that the target date for IVDs will be met.
DIMDI, the German organization which won the contract to develop and begin testing the European Commission sponsored database in 1996, is waiting for the Commission to give its final approval to the datasets needed to run the IVD section of the database. Rather than having products registered individually, they will be divided into some 50 to 100 groups. DIMDI needs this approval by the end of the year and will then integrate the datasets in a short time.
EUDAMED has been set up to meet the registration requirements in the medical device Directives, including the IVD Directive. It is a database allowing manufacturers to register, through their competent authorities, Class I (low-risk) and custom-made devices and to provide details for notified bodies' certificates for Class II and III devices. For all IVDs, manufacturers have to provide information to the authorities by category, in terms of common characteristics of technology and/or analytes.
All EU member states, with the exception of Greece, the Netherlands and Portugal, have sent information on devices to the database. It is still early days, however, as of the 55,000 datasets contained, some 40,000 are from users of custom-made devices, mainly based in Germany. The remaining 500 are from authorised representatives, and 15,000 from manufacturers.
DIMDI is working to provide a smooth link between two different nomenclature systems: the UMDNS that is currently being used for inputting information; and the GMDN terms which should be ready in English by next March or April. This will obviate the need for manufacturers and authorities to resent medical device information in the new nomenclature and will ensure there are not delays in setting up the IVD database.
The Commission expects that industry will ultimately have access to EUDAMED. Although this is not planned in the short-term, there is no reason why access should be limited to competent authorities. However, there may be some aspects which would have to remain confidential.
It would be plausible to expand access in this way. The pharmaceutical equivalent is split, so that insurance companies, for example, have access to one set of information, and competent authorities to another.
DIMDI has applied to the Commission to take over the running of the system on a permanent basis, but financing issues are delaying a decision.
The German organization aims to be a one-stop shop for regulatory data. It is developing a classification database which should help the authorities verify how similar products have been classified in Europe and is inviting regulators to help build up this data. It has recently been contracted by the German ministry to develop a database for evidence-based medicine.
DIMDI would like to integrate a vigilance database into its services. If asked by the Commission, they would make a proposal to do this. The organization already runs the German medical device vigilance system.
There has recently been considerable speculation as to the practicality of developing a common language for vigilance purposes and some experts predict it will be years before this is completed. DIMDI, meanwhile, is optimistic that English could be used as a common language - as is already the case for the German medical device vigilance system.
BACK TO OVERVIEW