The enforcement of the harmonised legislation on medical devices is the responsibility of the authorities in EU countries.
The Medical Devices Directives establish specific procedures that the national authorities must follow when considering whether or not:
When justified, the European Commission ensures that such procedures are applied throughout the EU. In addition, EU countries are entitled to set requirements on health grounds regarding the withdrawal from the market or the placing on the market of a given product or group of products ('particular health monitoring measures'). Ideally, such measures should be adopted as EU measures.
The purpose of the Medical Device Vigilance System is to improve the protection of health and safety of patients, healthcare professionals, and other users by reducing the likelihood of reoccurrence of incidents related to the use of a medical device.
The Medical Devices Directives provide that adverse incidents are evaluated and, where appropriate, information is disseminated in the form of a National Competent Authority Report (NCAR).
This serves to prevent repetition of such incidents through the adoption of appropriate field safety corrective actions.
The provisions on vigilance of the Medical Devices Directives are complemented by general guidelines on vigilance intended for facilitating and harmonising the implementation of the EU Directives on Medical Devices by manufacturers and competent authorities.
Eudamed2 is the European Databank on Medical Devices. Its purpose is to strengthen market surveillance and transparency in the field of medical devices, by providing national competent authorities with fast access to information. It also contributes to a uniform application of the Directives.
Depending on the applicable directive, Eudamed2 contains data :
An important tool for Eudamed2 is the Global Medical Device Nomenclature (GMDN).
The development of the GMDN originated with a mandate to the European Committee for Standardisation (CEN) for the development of a structure for a medical device nomenclature. This resulted in the European standard EN ISO 15225 'Nomenclature - specification for a nomenclature system for medical devices for the purpose of regulatory data exchange'.
It has since been further developed into a CEN technical report.
Maintenance of this work was taken over by the GMDN Maintenance Agency, which further developed the Nomenclature. It represents a comprehensive, regularly updated web-based nomenclature, accessible to manufacturers upon payment of a license fee. GMDN presents the best practice for Eudamed2 purposes.