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.


Stay up-to-date

We use your email address exclusively for sending our newsletter. You have the right to revoke your consent at any time with effect for the future. For further information, please refer to our privacy policy.