Noti­fied Bod­ies have a cru­cial role in the CE Mark­ing process. Below you will find an overview of the role of Noti­fied Bod­ies and what is impor­tant when select­ing and chang­ing the provider.

What is a Noti­fied Body (NB)?

A NB is a third-par­ty orga­ni­za­tion that has been des­ig­nat­ed by a EU mem­ber state’s com­pe­tent author­i­ty to car­ry out tasks relat­ed to con­for­mi­ty assess­ment pro­ce­dures for the applic­a­ble leg­is­la­tion. In our case, the applic­a­ble leg­is­la­tion refers to Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR), Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR) and to the Med­ical Devices Direc­tive 93/42/EEC (MDD), the Active Implantable Med­ical Devices Direc­tive 90/385/EEC (AIMDD) and the In Vit­ro Diag­nos­tic Med­ical Devices Direc­tive 98/79/EC (IVDD).

It is vital to choose the right NB for your orga­ni­za­tion – chang­ing the NB may be chal­leng­ing and expen­sive in many ways.

The involve­ment is not nec­es­sary for med­ical devices of class I unless they have a mea­sur­ing func­tion or are sold in ster­ile con­di­tion or (only applic­a­ble for the MDR) are reusable sur­gi­cal instru­ments. For IVD prod­ucts, a NB is only required when the prod­uct is list­ed under annex II of the IVDD. Under the IVDR all prod­ucts need an NB unless the device falls into class A.

Selec­tion of a NB

It is vital to choose the right NB for your orga­ni­za­tion – chang­ing the NB may be chal­leng­ing and expen­sive in many ways. In addi­tion, the num­ber of NBs has decreased over the past years. With the MDR and IVDR becom­ing ful­ly applic­a­ble in May 2020 or May 2022 respec­tive­ly, this bot­tle-neck is expect­ed to increase. To date, only four NBs have been des­ig­nat­ed for the MDR and none for the IVDR. It is impor­tant to select an NB who will con­tin­ue to be des­ig­nat­ed under the MDR and IVDR.

Inde­pen­dent from the low avail­abil­i­ty of MDR and IVDR NBs at present, we out­lined some impor­tant prepara­to­ry steps to con­sid­er when select­ing an NB below:

Once you have pre-select­ed poten­tial orga­ni­za­tions, you may request addi­tion­al infor­ma­tion as list­ed below to final­ize your deci­sion. Please be aware that not all of these items might be avail­able upon request:

Change of the NB

The rea­sons for chang­ing a NB can be man­i­fold: For exam­ple, a man­u­fac­tur­er may acquire cer­tain prod­ucts that have been CE marked under a dif­fer­ent NB. Some­times, poor cus­tomer ser­vice and low avail­abil­i­ty in times of time­ly pres­sure is an issue. Cur­rent­ly, it cer­tain­ly is the unsafe­ty regard­ing the MDR/ IVDR and Brex­it that play a cen­tral role.

Notwith­stand­ing the rea­sons, chang­ing the NB is a high­ly for­mal process. Sev­er­al aspects should be con­sid­ered and followed:

Do you want to know more or require assis­tance in find­ing or chang­ing your NB? Please get in touch with us and find out how we can help you!

Sources: MDR, IVDR, MDD, AIMDD, IVDD, NBOG guidance