A Notified Body is an independent certification organization that is “notified” by a European Member State’s Competent Authority to determine if a product or system meets applicable requirements for CE marking.
Each Member State has its own Competent Authority in charge of market surveillance and for designating and monitoring the independent Conformity Assessment Bodies. The procedure to designate the Conformity Assessment Bodies is called “notification” hence the name “Notified Body.”
Most medical device manufacturers who seek to sell their devices in Europe must work with Notified Bodies. Only non-sterile class I devices without measuring function do not require the involvement of a Notified Body. The manufacturer of such devices marks them under his sole responsibility with the CE-mark without a number. All other devices require the certification by a Notified Body before the manufacturer can put the CE mark in combination with the number of the Notified Body on the device.
The main tasks of the notified body are to provide conformity assessment services according to the Directives. Their activities include:
-
Confirmation of the qualification and the classification of the medical device
-
Assessment of the technical documentation
-
Assessment of the manufacturer’s quality system
-
Assessment of critical subcontractors
-
Issuance of CE certificates
Assessment of technical documentation aims to verify compliance of the device with applicable essential requirements while assessment of the quality system aims to verify that the manufacturer has established and maintains a set of policies, procedures and practices to demonstrate its ability to provide medical devices that consistently meet applicable regulatory requirements. Issuance of CE certificates enable the manufacturer to issue the necessary declaration of conformity and place the devices on the market.
The list of Notified Bodies, their scope of notification, and the list of Competent Authorities can be found on the NANDO website (New Approach Notified and Designated Organisations).
Notified Bodies are free to offer their conformity assessment services for which they are notified to any manufacturer established either inside the EU or in third countries. Manufacturers are free to choose any notified body that has been legally designated to carry out the conformity assessment procedure.
HTCert is a Notified Body for the Medical Device Directive 93/42/EEC (MDD).
