MDR: requi­re­ments for ins­truc­tions for use for medi­cal devices

Ins­truc­tions for use are part of the labe­l­ing of medi­cal devices and are sub­ject to strict regu­la­to­ry requi­re­ments, which will be tigh­ten­ed signi­fi­cant­ly with the ent­ry into force of the MDR (PDF) rela­ti­ve to the pro­vi­si­ons in pre­vious Directives.

Defi­ni­ti­on of “Ins­truc­tions for Use”

In accordance with the Medi­cal Device Regu­la­ti­on, the term “ins­truc­tions for use” refers to the infor­ma­ti­on pro­vi­ded by the manu­fac­tu­rer to inform the user of a device’s inten­ded pur­po­se and pro­per use and of any pre­cau­ti­ons to be taken.

The ins­truc­tions for use must be pro­vi­ded tog­e­ther with the device. By way of excep­ti­on, ins­truc­tions for use are not requi­red for Class I and Class IIa devices if such devices can be used safe­ly wit­hout any such ins­truc­tions and unless other­wi­se spe­ci­fied in the MDR. Manu­fac­tu­r­ers which do not plan on pro­vi­ding ins­truc­tions for use will have to con­front the ques­ti­on as to whe­ther their device can be used safe­ly even wit­hout accom­pany­ing ins­truc­tions for use as part of their risk manage­ment acti­vi­ties. It will be neces­sa­ry for them to iden­ti­fy and eva­lua­te poten­ti­al risks and to explain why ins­truc­tions for use are not of cri­ti­cal importance in this par­ti­cu­lar case.

If ins­truc­tions for use can­not be dis­pen­sed with, manu­fac­tu­r­ers may have the opti­on in cer­tain cases to pro­vi­de the ins­truc­tions in elec­tro­nic form. Regu­la­ti­on (EU) No. 207/2012 (PDF) on elec­tro­nic ins­truc­tions for use of medi­cal devices will con­ti­nue to app­ly in this regard for the time being, even under the MDR.

Mini­mum Con­tent of Ins­truc­tions for Use under the MDR

In accordance with the MDR, ins­truc­tions for use for medi­cal devices must con­tain cer­tain key infor­ma­ti­on. Asi­de from infor­ma­ti­on about the pro­duct (name/trademark, pro­duct ID) and the manu­fac­tu­rer (name, address, cont­act infor­ma­ti­on), infor­ma­ti­on about the fol­lo­wing is also required:

• inten­ded purpose;
• indi­ca­ti­ons and contra-indications;
• pati­ent tar­get group and inten­ded users;
• spe­ci­fi­ca­ti­on of the cli­ni­cal bene­fit to be expected;
• avai­la­bi­li­ty of the sum­ma­ry of safe­ty and cli­ni­cal per­for­mance (high-risk devices);
• the device’s per­for­mance characteristics;
• spe­ci­fi­ca­ti­ons which are requi­red for appro­pria­te use of the device;
• ste­ri­liza­ti­on, final assem­bly, cali­bra­ti­on, clea­ning and disinfection;
• neces­sa­ry qua­li­fi­ca­ti­ons for users;
• any recon­di­tio­ning procedures;
• sto­rage, trans­port, durability;
• com­bi­na­ti­on with other devices, inclu­ding accessories;
• main­ten­an­ce and repair;
• sym­bols and iden­ti­fi­ca­ti­on colors.

Design of Ins­truc­tions for Use

Ins­truc­tions for use are to be desi­gned in such a way as to satis­fy regu­la­to­ry requi­re­ments while at the same time being clear and under­stan­da­ble for the users spe­ci­fied in the device’s inten­ded pur­po­se. A struc­tu­red and con­sis­tent design are of essen­ti­al importance in this regard. In par­ti­cu­lar, it should be ensu­red that sym­bols are used in a con­sis­tent man­ner and that the infor­ma­ti­on per­tai­ning to inten­ded use, hand­ling, clea­ning, main­ten­an­ce, etc. is pre­sen­ted in a non-contradictory man­ner. Aspects which are not rele­vant for this spe­ci­fic device should be left out (e.g. no infor­ma­ti­on about recon­di­tio­ning if the device can­not be reconditioned).

The lan­guage in which the ins­truc­tions for use must be pro­vi­ded is deter­mi­ned by the mem­ber sta­tes. The gene­ral rule under the MDR is that ins­truc­tions must be pro­vi­ded in the lan­guages accept­ed in the mem­ber sta­tes whe­re the device is to be sold. 

Rele­van­ce of Ins­truc­tions for Use for Regu­la­to­ry and Lia­bi­li­ty Purposes

Manu­fac­tu­r­ers are requi­red to ensu­re that the ins­truc­tions for use of their devices con­form to the requi­re­ments of the MDR. If the ins­truc­tions for use fail to con­form to the pro­vi­si­ons of the MDR, par­ti­cu­lar­ly tho­se in Annex I Chap­ter III (Requi­re­ments Regar­ding the Infor­ma­ti­on Sup­pli­ed with the Device), this may result in the com­pe­tent super­vi­so­ry aut­ho­ri­ty orde­ring a mar­ke­ting or sales freeze.

Manu­fac­tu­r­ers could also face lia­bi­li­ty risks: after all, manu­fac­tu­r­ers could be held lia­ble not only for inju­ries ari­sing from the use of an unsafe or defec­ti­ve device, but also for inju­ries suf­fe­r­ed by pati­ents or users who used the device impro­per­ly becau­se the ins­truc­tions for use were con­fu­sin­gly for­mu­la­ted, wrong or incom­ple­te. This also appli­es with regard to erro­n­eous infor­ma­ti­on in trans­la­ted ver­si­ons of the ins­truc­tions for use. The lia­ble par­ty is the manu­fac­tu­rer in each case, regard­less of whom the manu­fac­tu­rer hired to trans­la­te the ins­truc­tions for use.