…for many man­u­fac­tur­ers of prod­ucts for gen­er­al lab­o­ra­to­ry use like pipettes, cen­trifuges, ther­mo­cy­clers or glass micro­scope slides.

Some man­u­fac­tur­ers are in the mis­tak­en belief, that their device is reg­u­lat­ed by Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR). Oth­er man­u­fac­tur­ers would sim­ply like to mar­ket their device as an IVD for mar­ket­ing pur­pos­es. In both cas­es they declare their “gen­er­al lab­o­ra­to­ry use” device as an IVD, try to cre­ate the Tech­ni­cal Doc­u­men­ta­tion, sign the Dec­la­ra­tion of Con­for­mi­ty and affix the CE mark. How­ev­er, many of them over­look the fact that their device does not fall under the scope of the IVDR at all. In doing so they encounter numer­ous prob­lems dur­ing the con­for­mi­ty assess­ment, espe­cial­ly when draw­ing up the per­for­mance evaluation.

These man­u­fac­tur­ers clas­si­fy the device as Class A by refer­ring to IVDR clas­si­fi­ca­tion rule 5a and b, read­ing only the first part: “The fol­low­ing devices are clas­si­fied as class A: a) prod­ucts for gen­er­al lab­o­ra­to­ry use, … b) Instru­ments (…)“. But they over­look the sec­ond part of those rules: “… a) intend­ed by the man­u­fac­tur­er to make them suit­able for in vit­ro diag­nos­tic pro­ce­dures relat­ing to a spe­cif­ic exam­i­na­tion. b) intend­ed by the man­u­fac­tur­er specif­i­cal­ly to be used for in vit­ro diag­nos­tic pro­ce­dures”. How­ev­er, this sec­ond part is absolute­ly essen­tial: It deter­mines if your device falls defin­i­tive­ly under the scope of the IVDR or not.

Here is an exam­ple: If your device is an ELISA ana­lyz­er but it is not specif­i­cal­ly intend­ed to be used for in vit­ro diag­nos­tic pro­ce­dures and could for exam­ple be used by vet­eri­nar­i­ans to run an ELISA with ani­mal spec­i­mens, it is not an IVD per def­i­n­i­tion by the IVDR. How­ev­er, if the ana­lyz­er is intend­ed to per­form and ana­lyze one or more spe­cif­ic enzyme immunoas­says, the require­ments for Rule 5b are met and you indeed have devel­oped an in vit­ro diag­nos­tic med­ical device (MDCG 2020-16).

We rec­om­mend three steps to make sure, that your device is an in vit­ro diag­nos­tic med­ical device:

Step 1: Com­pose the intend­ed pur­pose of your device with great care. Describe exact­ly to which spe­cif­ic IVD examination(s) your device is relat­ing. To include every rel­e­vant aspect, use IVDR Annex I, 20.4.1 c) as a check­list for the intend­ed purpose.

Step 2: Check if your device is intend­ed for a med­ical pur­pose, such as the diag­no­sis of a dis­ease or injury of a human being. Use the MDR def­i­n­i­tion for ‘med­ical devices’ (MDR, Arti­cle 2 ‘Def­i­n­i­tions’) and the IVDR def­i­n­i­tion for ‘in vit­ro diag­nos­tic med­ical devices’ (IVDR, Arti­cle 2 ‘Def­i­n­i­tions’). Regard­less of whether it is a PCR cycler, ELISA ana­lyz­er or sequencer: if your device is intend­ed for the exam­i­na­tion of spec­i­mens from the human body but with­out a spe­cif­ic IVD appli­ca­tion, your device is “only” for gen­er­al lab­o­ra­to­ry use and not an in vit­ro diag­nos­tic med­ical device. Your device defin­i­tive­ly has a med­ical pur­pose, if you can prove that its use results in diag­nos­tic infor­ma­tion for an indi­vid­ual patient.

Step 3: Make sure, that your device is used to exam­ine spec­i­mens derived from the human body. If you can think of your device being used by lab­o­ra­to­ries con­duct­ing vet­eri­nary diag­nos­tics or envi­ron­men­tal or food analy­sis, go back to your intend­ed pur­pose and refine it.

So, pre­pare the intend­ed pur­pose of your device with great care!

Any uncer­tain­ties and ambi­gu­i­ties in the clas­si­fi­ca­tion of your device result from the intend­ed pur­pose being incom­plete or vague­ly draft­ed. So, pre­pare the intend­ed pur­pose of your device with great care! The intend­ed pur­pose is the foun­da­tion on which your Tech­ni­cal Doc­u­men­ta­tion (your house) is built. If it shakes, it will not only be very dif­fi­cult to build the house, but also to keep it sta­ble dur­ing use and pre­vent it from col­laps­ing. In con­trast, you will great­ly ben­e­fit from a pre­cise­ly for­mu­lat­ed intend­ed pur­pose. The clear­er you are about what claims you want to prove, the eas­i­er it will be for you to cre­ate your doc­u­ments (per­for­mance eval­u­a­tion, lit­er­a­ture search strat­e­gy, PMS doc­u­ments). So, take a step back and check the intend­ed pur­pose crit­i­cal­ly. You and your device will ben­e­fit great­ly from this!

This arti­cle was writ­ten by Dr. Car­men Peeß, Astra­Con GmbH.

To receive fur­ther infor­ma­tion on this sub­ject, please notice the fol­low­ing arti­cles and con­tent on our website