IVDR – In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (EU) 2017/746

Reg­u­la­tion (EU) 2017/746 – also known as the In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (IVDR) was adopt­ed on May 25, 2017 and thus replaced the In Vit­ro Diag­nos­tic Med­ical Devices Direc­tive (IVDD). The Reg­u­la­tion became ful­ly applic­a­ble on May 26, 2022. There are mas­sive changes com­pared to the IVDD con­fronting man­u­fac­tur­ers with numer­ous challenges.

The pro­vi­sions for per­for­mance eval­u­a­tion have been revised. The cor­re­spond­ing doc­u­ments are sub­ject to enhanced scrutiny.

Major Reg­u­la­to­ry Changes

For instance, there is a new clas­si­fi­ca­tion sys­tem with new risk class­es. An esti­mat­ed 80% of pro­duc­ers will find their prod­ucts grouped in high­er risk class­es under the IVDR thus need­ing a Noti­fied Body to remain in com­pli­ance. There is also an extend­ed ver­sion of the Essen­tial Require­ments, now called the Gen­er­al Safe­ty and Per­for­mance Prin­ci­ples or Require­ments (SPR). More­over, the pro­vi­sions for per­for­mance eval­u­a­tion have been revised. The cor­re­spond­ing doc­u­ments are sub­ject to enhanced scrutiny.

The gen­er­al process for IVDR com­pli­ance is reflect­ed below.

IVDR Com­pli­ance Process

1. Appoint your Euro­pean Autho­rized Rep­re­sen­ta­tive
   → Ask for our quotation!
2. Iden­ti­fy all EU Directives/Regulations applic­a­ble to your prod­uct (such as IVDR, WEEE, EMC etc.)
   → We will assist!
3. Select and per­form the con­for­mi­ty assess­ment pro­ce­dure applic­a­ble to your prod­uct 
   → We will guide you through!
4. Check your device against the Gen­er­al Safe­ty and Per­for­mance Require­ments (annex I)
   → We will pro­vide a checklist!
5. Iden­ti­fy the applic­a­ble har­mo­nized stan­dards for your prod­uct 
   → We will pro­vide a list!
6. Pre­pare a Tech­ni­cal File (annex II and III) and imple­ment a Qual­i­ty Man­age­ment Sys­tem 
   → We will assist!
7. Select a Noti­fied Body (except for class A) and sign your Dec­la­ra­tion of Con­for­mi­ty 
   → We will pro­vide lists and forms!

Major Aspects of the IVDR

Below you will find a col­lec­tion of impor­tant aspects under the In Vit­ro Diag­nos­tic Reg­u­la­tion (EU) 2017/746 (IVDR) includ­ing short expla­na­tions and links towards graph­ics, down­loads, pre­views on doc­u­ments etc. If there is any­thing we can help you with please don’t hes­i­tate to con­tact us!

Clas­si­fi­ca­tion Rules under the IVDR

The IVDR intro­duces a risk-based clas­si­fi­ca­tion sys­tem sim­i­lar to the MDR. Risk class­es range from A to D (A being the low­est and D the high­est risk class). Class B, C and D prod­ucts require the involve­ment of a Noti­fied Body. 

• Check the pre­views in our sup­port­ive infor­ma­tion sec­tion IVDR
• In addi­tion you might read our arti­cle “Noti­fied Body Selec­tion and Change”
• Vis­it the mdi Europa online library
• Con­tact our team

Tech­ni­cal Doc­u­men­ta­tion under the IVDR

Tech­ni­cal Doc­u­men­ta­tion require­ments under the IVDR fol­low a cer­tain pat­tern. mdi Europa set up a check­list and tem­plate to assist man­u­fac­tur­ers in the com­pi­la­tion of their Tech­ni­cal Files. You are also invit­ed to make use of our exten­sive expert net­work should you require in-depth sup­port. Please get in touch for fur­ther information!

• Check the pre­views on Tech­ni­cal Doc­u­men­ta­tion in our sup­port­ive infor­ma­tion section
• Con­tact our team

Gen­er­al Safe­ty and Per­for­mance Requirements

The SPR under the IVDR include many aspects that must be care­ful­ly con­sid­ered. mdi Europa set up a check­list that will help man­u­fac­tur­ers to com­ply with the IVDR. Please get in touch for fur­ther information!

• Check the pre­views in our sup­port­ive infor­ma­tion sec­tion IVDR
• For fur­ther infor­ma­tion, please get in touch with our team

Top-Lev­el Guid­ance from Euro­pean Institutions

Euro­pean insti­tu­tions pub­lished a num­ber of top-lev­el doc­u­ments to sup­port the IVDR tran­si­tion process, e.g. a Fact­sheet for Man­u­fac­tur­ers and an Imple­men­ta­tion Mod­el for the In Vit­ro Diag­nos­tic Med­ical Devices Regulation. 

We pro­vide our cus­tomers with all the required infor­ma­tion and guid­ance. To get a glimpse at some of the doc­u­ments, please use the fol­low­ing link(s). You are also invit­ed to make use of our exten­sive expert net­work should you require in-depth sup­port. For more infor­ma­tion, please get in touch with our team.

• Vis­it com­plete down­load sec­tion in the mdi Europa online library
• Con­tact our team

Unique Device Iden­ti­fi­ca­tion (UDI) under the IVDR

Under the IVDR regime, each man­u­fac­tur­er is oblig­ed to imple­ment a UDI sys­tem. The Basic UDI-DI must be includ­ed in the Tech­ni­cal Doc­u­men­ta­tion, Dec­la­ra­tion of Con­for­mi­ty and Noti­fied Body cer­tifi­cate. Basic UDI-DI and UDI-DI will be used for the reg­is­tra­tion in EUDAMED. 

In addi­tion, the UDI has to be reflect­ed on the label­ing. The Euro­pean Com­mis­sion and Med­ical Device Coor­di­na­tion Group (MDCG) issued some guid­ance doc­u­ments, e.g. on Basic UDI-DI and UDI-DI attrib­ut­es, on Basic UDI-DI and UDI-DI Changes and on UDI Core Elements. 

You may find these and oth­er use­ful doc­u­ments and links in our Library sec­tion. You are also invit­ed to make use of our exten­sive expert net­work should you require in-depth sup­port. Please get in touch for fur­ther information!

• View mis­cel­la­neous PDF files regard­ing UDI in the mdi Europa down­load section
• Vis­it our link sec­tion regard­ing the MDR/IVDR
• Con­tact our team

EUDAMED

Under the IVDR, EUDAMED serves as a cen­tral data­base for the reg­is­tra­tion of eco­nom­ic oper­a­tors and prod­ucts, but also for vig­i­lance report­ing and per­for­mance stud­ies. It is vital to choose the right part­ner to com­ply with the cor­re­spond­ing requirements. 

• Vis­it our com­plete link sec­tion regard­ing MDR/IVDR
• For fur­ther infor­ma­tion, please con­tact our team

Per­for­mance Eval­u­a­tion under the IVDR

A major chal­lenge of the IVDR refers to the updat­ed and spec­i­fied require­ments on per­for­mance eval­u­a­tion. This process is defined as a con­tin­u­ous process that is intend­ed to pro­vide suf­fi­cient clin­i­cal evi­dence to demon­strate that the intend­ed clin­i­cal ben­e­fits will be achieved and that the device is safe. mdi Europa has devel­oped a tem­plate to sup­port your per­for­mance eval­u­a­tion process. 

• View our down­load sec­tion of guid­ance doc­u­ments IVDR
• Check the pre­views in our sup­port­ive infor­ma­tion sec­tion IVDR
• For fur­ther infor­ma­tion, please con­tact our team

Post-Mar­ket Sur­veil­lance under the IVDR

PMS and in this con­text, Post-Mar­ket Per­for­mance Fol­low-Up (PMPF), is assigned an impor­tant role under the IVDR. Post-mar­ket data must be used to update essen­tial doc­u­ments, e.g. risk man­age­ment and per­for­mance eval­u­a­tion. Man­u­fac­tur­ers are required to pro­duce the cor­re­spond­ing doc­u­ments in accor­dance with the IVDR, e.g. the PMS Plan and Report/ Peri­od­ic Safe­ty Update Report (PSUR).

mdi Europa may pro­vide valu­able assis­tance on these points. Please get in touch for fur­ther information.

• View our down­load sec­tion of guid­ance doc­u­ments IVDR
• Check the pre­views in our sup­port­ive infor­ma­tion sec­tion IVDR
• For fur­ther infor­ma­tion, please con­tact our team