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Directives 90/385/EEC, 93/42/EEC and 98/79/EC on medical devices stipulate that regulatory data collected in accordance with the Directives should be stored in a European database accessible to competent authorities. In particular, the database should contain the following:
data relating to registration of manufacturers and authorised representatives and devices, excluding data related to custom-made devices;
data relating to Notified Body certificates issued or modified;
data obtained in accordance with the vigilance procedure for incidents;
data relating to clinical investigations.
Such a databank has been developed by the European Commission in cooperation with the Member States under the name ‘European Databank for Medical Devices (Eudamed)' and is already being used by numerous Member States on a voluntary basis.
As concerns data existing collected by Member States before 1st May 2011, Member States shall only need to input data on registration of manufacturers, authorised representatives and devices into Eudamed. This Decision shall apply as from 1st May 2011.
More information on Eudamed:
The aim of Eudamed is to strengthen and facilitate market surveillance by providing competent authorities with fast access to information on medical devices, as well as to contribute to a uniform application of the regulations, in particular in relation to registration requirements.
The only expected impacts are the following:
Thanks to such rapid communication channels between market surveillance authorities, the risk for patients of a safety incident or malfunctioning will be reduced. In particular, rapidly sharing information on any known incidents will diminish the risk of recurring incidents elsewhere in the EU.
A change in administration and data inputting procedures is required at the national Competent Authority level.
When registering medical devices with the Competent Authority, manufacturers or importers will now be required to give their postcode, phone or email, and an internationally recognized nomenclature code for their devices, in addition to the already requested information. This shall not apply to registration of custom-made devices.
Such internationally recognised nomenclature for medical devices is necessary to allow a uniform description of the devices concerned and efficient use of that databank. Given that data can be entered in all official languages of the Community, a numeric code should be used so that devices can be easily searched. The Global Medical Device Nomenclature is such an internationally recognised nomenclature, but it is not the only option that can be used. Such nomenclatures are normally obtained at a cost from private agencies.
Who will be effected?
Competent Authorities, Manufacturers, Authorised Representatives, Notified Bodies and Importers of Medical Devices.
Any feedback on the Decision would be appreciated by 4th June 2010. Should you require any further information please do not hesitate to contact Mr. David Pulis at MSA on E: T: 2395 2000
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