Before 1990 virtually all medical devices could be placed on the market in EU Member States without mandatory ‘approval.’ In the absence of mandatory approval, conscientious manufacturers chose to have their devices tested by independent test houses to voluntary standards. Over the years these test houses developed excellent reputations for their knowledge, understanding, integrity and impartiality in the testing of medical devices. Throughout the EEA, the expertise in assessing medical devices and the quality systems deemed necessary to control their design, manufacture and testing was deposited in these test houses.
Therefore, when the EU legislation was introduced, it was decided to grant the pre-market ‘approval’ of medical devices to these test houses. They were called Notified Bodies, and are ‘approved’ by the Competent Authority in the Member State where they have their headquarters.
A debate has raged over the merits and demerits of Notified Bodies since before 1990 and ever since. Even at that time, some Competent Authorities wanted to carry out pre-market approvals, create mandatory standards etc.
Device ‘approvals’ exist to ensure that the only those products reach the market which are ‘safe’ and can function to their intended purpose. The ‘approval’ procedure must strike a careful balance between being too stringent and preventing or causing delays for new or better devices reaching the market, and being too lenient and allowing unsafe devices reaching the market.

A list of EU Notified Bodies is available.