Medical devices competent authorities

In the case of IVDs that require the involvement of a Notified Body, data on performance characteristics, the results of performance evaluation and device certificates issued by the Notified Body must be included in the submission. The Competent Authorities are responsible for entering the following information in a European medical device databank, EUDAMED ... 

As described previously, persons responsible for placing medical devices on the EU market are only required to notify the Competent Authority in the state where... 

The responsibilities of Competent Authorities in terms of market vigilance are set out in the Articles of the device directives, whereas the obligations for manufacturers are contained in the Armexes. MEDDEV guide 2.12-1 provides detailed practical guidance on how the medical device vigilance system should operate within the EU, the European Economic Area (EEA) and Switzerland. This guidance was significantly... 

The Competent Authority to which the incident was originally reported usually takes on the role of monitoring and evaluating how the incident is dealt with. When all actions are complete, including any necessary Field Safety Correction Actions, the manufacturer must submit a final report to the Competent Authority. Under a safeguard clause. Competent Authorities may take unilateral action to remove a device from their market, if they believe that it poses an unacceptable health risk, but the Commission must be informed of such actions. In less-urgent situations, concerns may be referred to the Committee for Medical Devices for consideration. 

Active Implantable Medical Devices Directive 90/385 EEC Article 8 (Competent Authority Vigilance procedure), Annex II 3.1 (manufacturer s vigilance and reporting duties)... 

The Irish Medicine Board (IMB) (www.imb.ie). who is the Competent Authority under the Medical Devices Directive for Ireland,... 

The duties of EU manufacturers with respect to adverse-event notification and evaluation have been regulated in the Product Safety Directives, but for the operation of a vigilance system to enhance patient safety, there are only guidelines and no law. In practice, this means that EU manufacturers are obliged to notify any adverse event to the competent authority of their country (e.g., the medical device agency of the National Health Inspectorate). The... 

The EU mandate clearly gives the national Competent Authority (MHRA) powers to define the classification of a medical device ... 

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