CE marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation.

CE Marking of Medical Devices
The Medical Devices Directives set out essential requirements to ensure that a medical device will not compromise the health and safety of the patient, user or any other person, and that any risks associated with the device are compatible with patient health and protection. Devices that conform to these requirements are entitled to apply the CE Marking, which then allows the product to be freely placed on the market within the EU. There are three EU medical device directives, covering devices ranging from active implantable to in-vitro diagnostic devices.

Competent Authorities / Notified Bodies:
In each EU member state there is a Competent Authority whose responsibility is to monitor and ensure compliance with the Directives, and in Ireland the Irish Medicines Board (IMB) operates in this role.

The Competent Authority approves bodies to carry out the conformity assessment tasks. These bodies are called Notified Bodies. Since August 1994 NSAI has been the Notified Body assigned to carry out the tasks set out in Annex II, V and VI of the Medical Devices Directive (90/42/EEC) and Annex II and V of the Active Implantable Medical Devices Directive (90/385/EEC). On 31st July 2002, NSAI was officially designated as a Notified Body under the In-Vitro Diagnostic Medical Devices Directive (98/79/EC) by the IMB.

In order to assess a manufacture's quality systems in support of the above directives, NSAI uses ISO 13485:2003 Quality Management Systems, Requirements for Regulatory Purposes. This internationally recognized quality standard outlines particular quality management system requirements tailored to the manufacture of medical devices. ISO 13485:2003 also references the international guidance document ISO 14969:2004 - Quality management systems -- Guidance on the application of ISO 13485: 2003, developed to assists device manufacturers on the application of ISO 13485:2003.

Once a manufacturer has met the requirements of the directive, then the device may carry the CE Marking, and where NSAI, as a Notified Body is involved, the Notified Body number (0050) is to appear with the CE Marking. Continuing compliance with the requirements of the directives is assessed through regular surveillance audits by NSAI .

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