Post-Market Activities

The Human Products Monitoring Department manages compliance and vigilance cases that arise as a result of placing the medical device on the market.

(1) Vigilance
Article 8 of the Active Implantable Medical Device (AIMD) Directive 90/385/EEC, Article 10 of the Medical Device Directive 93/42/EEC and Article 11 of the In-vitro Diagnostic Medical Device 98/79/EC outlines the obligations of Member States upon the receipt of incident reports, from manufacturers or other sources, concerning any medical device. Further details can be found in the IMB Guide to the Vigilance System for Medical Devices.

(2) Compliance
The purpose of compliance is to ensure that the provisions of medical devices legislation are complied with after devices are placed on the market or put into service. It aims to ensure that non-compliant devices are removed from the market.

(3) Certificates of Free Sale
Certificates of free sale for general medical devices, active implantable medical devices and in-vitro diagnostic medical devices are issued by the Compliance Department of the IMB.

The Irish Medicines Board - www.imb.ie

Post-Market Activities