Noti­fied Body Selec­tion and Change

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:

• Set up a team
  • Deter­mine indi­vid­u­als respon­si­ble for the selec­tion process
  • Team should include rep­re­sen­ta­tives at least from reg­u­la­to­ry and qual­i­ty department
• Pre­pare a com­pa­ny and prod­uct sum­ma­ry, includ­ing details like
  • a com­pa­ny description
  • the num­ber of employ­ees and rel­e­vant man­u­fac­tur­ing processes
  • sup­pli­ers and sub­con­trac­tors used
  • device descrip­tions of prod­ucts that are to be sold under the EU legislation
  • cho­sen con­for­mi­ty assess­ment procedure
  • desired sched­ule
• Based on the sum­ma­ry, you may devel­op a pref­er­ence list to pre-select 3-5 poten­tial NBs, e.g. based on
  • leg­is­la­tion and prod­uct types they are cur­rent­ly des­ig­nat­ed for
  • reg­u­la­tions and assess­ment meth­ods they are seek­ing re-des­ig­na­tion for
  • office loca­tions
  • lan­guage skills
  • required spe­cif­ic areas of expertise

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:

• detailed quo­ta­tion with ser­vices and fees
• ref­er­ences
• audit check­lists
• infor­ma­tion package
• appli­ca­tion package

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:

• The Noti­fied Body Oper­a­tions Group (NBOG) issued a guid­ance doc­u­ment that pro­vides impor­tant insights about the change process (VERLINKEN).
• It is pro­hib­it­ed to have two out­stand­ing appli­ca­tions with two sep­a­rate NBs.
• It is high­ly rec­om­mend­able to set up an agree­ment and plan between you, the out­go­ing NB and the incom­ing NB that details all aspects affect­ed by the change, e.g.:
  • inva­lid­i­ty of cer­tifi­cates of out­go­ing NB
  • dates of new certificates
  • oblig­a­tions regard­ing labeling
  • respon­si­bil­i­ties and timelines
• Against the points above and in coor­di­na­tion with the out­go­ing and incom­ing NB, you should make sure that old labels are not used longer than six months after the new cer­tifi­cate is avail­able – unless duly jus­ti­fied. The point in time when the switch to the new labels will take place, should be clear­ly defined.

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