You are a med­ical device man­u­fac­tur­er and have CE marked your prod­ucts under the In Vit­ro Diag­nos­tic Med­ical Devices Direc­tive 98/79/EC (IVDD)? Then you must tran­si­tion to the IVDR in the future to keep your prod­ucts on the Euro­pean mar­ket. Below you will find a brief syn­op­sis of the 11 most impor­tant changes includ­ing links to guid­ance and templates.

1. Shift from pre-approval to a life-cycle approach

The IVDR pro­motes a shift from pre-approval to a life-cycle approach. Risk man­age­ment and the con­nect­ed process­es on PMS and per­for­mance eval­u­a­tion must be con­duct­ed con­tin­u­ous­ly through­out the product’s life cycle.

2. Clas­si­fi­ca­tion changes

Con­trary to the list-based sys­tem under the IVDD, the IVDR pro­vides for a risk based clas­si­fi­ca­tion sys­tem with class­es from A to D (A being the low­est and D the high­est risk class).
Please see here for an overview of the IVDR clas­si­fi­ca­tion rules.

3. Super­vi­sion

The IVDR brings a stronger super­vi­sion of man­u­fac­tur­ers by Noti­fied Bod­ies. Man­u­fac­tur­ers of all risk class­es except for class A will require a Noti­fied Body cer­tifi­cate to CE mark their prod­ucts. An esti­mat­ed 80-90% of man­u­fac­tur­ers will thus be required to take this step where­as it was nec­es­sary only for 10-20% of com­pa­nies under the IVDD. This is clear­ly one of the most dra­mat­ic changes for the indus­try.
Please also read our arti­cle “Noti­fied Body Selec­tion and Change”.
You are wel­come to con­tact us should you require our sup­port to iden­ti­fy your Noti­fied Body.

4. Clear­er rights and respon­si­bil­i­ties for eco­nom­ic operators

With the IVDR roles of eco­nom­ic oper­a­tors (man­u­fac­tur­er, autho­rized rep­re­sen­ta­tive, dis­trib­u­tor, importer) have been nar­row­ly defined. Each eco­nom­ic oper­a­tor must ensure that the cor­re­spond­ing role is ful­ly under­stood and agree­ments are set up accord­ing­ly.
Please see here for the fact­sheets issued by the Euro­pean Commission. 

5. Trace­abil­i­ty / EUDAMED

The IVDR requires man­u­fac­tur­ers of all class­es to imple­ment a UDI sys­tem for enhanced trace­abil­i­ty. UDI com­po­nents will also be used for the reg­is­tra­tion in the new upgrad­ed EUDAMED data­base. EUDAMED will replace nation­al reg­istries that have been oper­at­ed under the IVDD.
For guid­ance issued by the Euro­pean Com­mis­sion on these top­ics, please vis­it its website.

6. The new Gen­er­al Safe­ty and Per­for­mance Requirements

The new Gen­er­al Safe­ty and Per­for­mance Require­ments (SPR) will replace the Essen­tial Require­ments (ER). The SPR are much more com­pre­hen­sive than the for­mer ER and also bring new or amend­ed require­ments, e.g. on label­ing. In addi­tion, man­u­fac­tur­ers are required to com­plete the cor­re­spond­ing check­list in much more detail.
You find a pre­view of a SPR check­list in our Sup­port­ive Infor­ma­tion Sec­tion for the IVDR.

7. Per­for­mance eval­u­a­tion and clin­i­cal evidence

The IVDR nar­row­ly defines the per­for­mance eval­u­a­tion, 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 set up a tem­plate that will guide you through the entire process.
You find a pre­view of the per­for­mance eval­u­a­tion tem­plate in our Sup­port­ive Infor­ma­tion Sec­tion for the IVDR.

8. Tech­ni­cal file structure

Annex II and III of the IVDR pro­vide details about the required con­tents of a tech­ni­cal file. Noti­fied Bod­ies and com­pe­tent author­i­ties made clear that they expect manufacturer’s doc­u­men­ta­tion to be pre­pared read­i­ly search­able and in line with the revised struc­ture.
You find a pre­view of tech­ni­cal file check­lists in our Sup­port­ive Infor­ma­tion Sec­tion for the IVDR.

9. Per­son Respon­si­ble for Reg­u­la­to­ry Compliance

Man­u­fac­tur­ers must employ a per­son in their orga­ni­za­tion who is in charge of the company’s reg­u­la­to­ry com­pli­ance. This per­son has to pos­sess a defined set of qual­i­fi­ca­tions or expe­ri­ence respec­tive­ly.
Please see here for the cor­re­spond­ing guid­ance document.

10. Lia­bil­i­ty

Man­u­fac­tur­ers are required to pro­vide suf­fi­cient finan­cial cov­er­age for poten­tial lia­bil­i­ty claims. The EU Autho­rized Rep­re­sen­ta­tive will become liable for the manufacturer’s prod­ucts as well. 

11. Own Brand Label­ing (OBL)

The con­cept of OBL will be obso­lete under the MDR as there will no more dif­fer­ence between the Orig­i­nal Equip­ment Man­u­fac­tur­er (OEM) and the OBL com­pa­ny. 
We rec­om­mend our arti­cle OEM – Pri­vate Label­ing.

Source: IVDR

Do you require fur­ther assis­tance in your tran­si­tion process? 

Please have a look at our Library.
Read our in-depth infor­ma­tion on page “IVDR”.
Or get in touch with us direct­ly for fur­ther advice.