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Market surveillance and vigilance

Market surveillance and vigilance

Market surveillance

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:

  • a medical device is unsafe and should be withdrawn from the market ('safeguard clause')
  • a CE marking is unduly affixed to a device or missing ('wrongly affixed CE marking').

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.

Vigilance

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.

Statistics

EU pilot on trending

Currently incident reports from manufacturers are collected and assessed at national level.  To better and earlier detect an outstanding issue which may have major adverse effects for patients, it is important to collect and treat incident data at EU level directly to gather many more incident reports for the same devices in a shorter period of time.

The EU pilot on trending aims to establish an EU data repository which enables the development of new tools for signal detection and trending purposes. The registration of data related to incidents is extended. In particular, the use of various international nomenclatures is introduced and data for similar incidents are consolidated according to different periods of time.

To that end, an additional reporting form is introduced as well as a toolkit for users. The pilot phase starts from May 2015 and is foreseen to last until the end of 2015 at least.

Eudamed - European Databank on Medical Devices

Eudamed 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.

Which information is stored in Eudamed?

Depending on the applicable directive, Eudamed contains data :

  • on registration of manufacturers, authorised representatives and devices;
  • relating to certificates issued, modified, supplemented, suspended, withdrawn or refused;
  • obtained in accordance with the Medical Device Vigilance System;
  • on clinical investigations.

Who can access Eudamed?

  • Eudamed is a secure, web-based portal, which serves as a central repository for information exchanged between national competent authorities and the Commission. It is not publicly accessible.
  • Eudamed use is obligatory since May 2011.
  • The operational functioning and the added value of the databank have been evaluated and the Eudamed Evaluation (380 kB) results are publicly available.

Global Medical Device Nomenclature (GMDN) use in Eudamed

An important tool for Eudamed 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 Eudamed purposes.

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