What to do if your Notified Body has stopped its activity

The changes in the regulation of medical devices also impacts the activities of Notified Bodies. In the past few months, some of these organisations responsible for the CE marking of medical devices have stopped their activity, either voluntarily or by decision of the competent authority of their country. Manufacturers who have their medical devices CE marked by these Notified Bodies must find a new organisation and get a new CE certification.

This represents extra work for the remaining Notified Bodies, so the process can be long. In some countries, medical devices must be registered by the Competent Authority before they can be placed on the market in this country. Without specific European regulation in this situation, some Competent Authorities have decided to implement measures in order to keep the concerned devices on the market after the withdrawal of their Notified Body. In France, ANSM decided to grant an exemption for up to 12 months for the marketing of the concerned devices with valid CE certificates from a withdrawn Notified Body, if the manufacturer makes the request to ANSM and provides some documents and information. One of these documents is the proof that the certification process with a new Notified Body has been started.

The list of active Notified Bodies is available via this link:
http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13