The approval process for med­ical devices fol­lows a cer­tain pat­tern: Author­i­ties select legal­ly and tech­ni­cal­ly inde­pen­dent, com­pe­tent bod­ies called Noti­fied Bod­ies to inde­pen­dent­ly check that man­u­fac­tur­ers are con­form­ing to the Direc­tives and Reg­u­la­tions requirements. 

Not all Noti­fied Bod­ies can check all tech­nolo­gies and not all mem­ber states have Noti­fied Bodies

It is impor­tant to note here that not all Noti­fied Bod­ies can check all tech­nolo­gies and not all mem­ber states have Noti­fied Bod­ies. Noti­fied Bod­ies must be able to demon­strate that they have the clin­i­cal, sci­en­tif­ic and tech­ni­cal com­pe­tence to check the tech­nolo­gies for which they are designated.

A small Range of Exceptions

NOTE: There is a small range of med­ical devices (low risk – class I) and the major part of in vit­ro diag­nos­tic (IVD) med­ical devices (low risk – oth­er IVD) that do not need this up front cer­ti­fi­ca­tion! Please note that under the In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (EU) 2017/746 (IVDR), 80-90% of IVD med­ical devices will require a Noti­fied Body under the new clas­si­fi­ca­tion sys­tem. 

A list of Noti­fied Bod­ies is avail­able on the web­site of the EU Com­mis­sion. You find a col­lec­tion of use­ful links at the end of this article.

As an addi­tion­al con­trol enti­ty, com­pe­tent author­i­ties mon­i­tor the work of the Noti­fied Bod­ies. They are also free to check and ver­i­fy a man­u­fac­tur­ers’ com­pli­ance with the EU leg­is­la­tion at any time as part of their mar­ket surveillance.

The Euro­pean Com­mis­sion is not your enemy

Final­ly, to improve coop­er­a­tion, the Euro­pean Com­mis­sion helps to orga­nize the exchange of expe­ri­ences between the author­i­ties respon­si­ble for mar­ket sur­veil­lance in order to coor­di­nate uni­form imple­men­ta­tion. This cre­ates a con­tin­u­ous loop of author­i­ty over­sight of med­ical devices and IVD med­ical devices.

The Med­ical Devices Reg­u­la­tion (EU) 2017/745 (MDR) and IVDR move this prin­ci­ple one big step for­ward: The Reg­u­la­tions are direct­ly imple­ment­ed into nation­al law. On top of that, the new ver­sion of the EUDAMED data­base will enhance super­vi­sion mech­a­nisms and col­lab­o­ra­tion among stakeholders.

List of use­ful links con­nect­ed to the Approval Process