Ins­truc­tions for use: digi­tal or analogue?

The ‘ins­truc­tions for use’ refer to infor­ma­ti­on pro­vi­ded by the manu­fac­tu­rer to inform the user about the inten­ded pur­po­se and cor­rect use of a pro­duct, as well as any pre­cau­ti­ons to be taken; Art. 2 No. 14 Regu­la­ti­on (EU) 2017/745 for medi­cal devices (MDR) (PDF). In par­ti­cu­lar, it is pro­hi­bi­ted to use texts, names, trade­marks, illus­tra­ti­ons and other pic­to­ri­al or non-pictorial signs on the label­ling and ins­truc­tions for use of pro­ducts that could mis­lead the user or pati­ent as to the inten­ded pur­po­se, safe­ty and per­for­mance of the pro­duct; Art. 7 MDR. The ins­truc­tions for use are pro­vi­ded tog­e­ther with the product.

Dis­cre­tio­na­ry natu­re of the ins­truc­tions for use

Accor­ding to Annex I MDR (PDF) (essen­ti­al safe­ty and per­for­mance requi­re­ments), Chap­ter III (Requi­re­ments for infor­ma­ti­on sup­pli­ed with the pro­duct), Sec­tion 23.1 (d), ins­truc­tions for use ‘are not requi­red for Class I and IIa pro­ducts in excep­tio­nal cases, if the safe use of the­se pro­ducts is gua­ran­teed wit­hout ins­truc­tions for use and unless other­wi­se spe­ci­fied else­whe­re in the MDR’.

The­r­e­fo­re, the fol­lo­wing applies:

• In prin­ci­ple, ins­truc­tions for use are required.
• The pos­si­bi­li­ty of dis­pen­sing with ins­truc­tions for use is an exception.
• This excep­ti­on can only app­ly to pro­ducts in risk clas­ses I to IIa.
• Ins­truc­tions for use are man­da­to­ry for pro­ducts in hig­her risk classes.

If the manu­fac­tu­rer wis­hes to invo­ke the dis­pensa­bi­li­ty of ins­truc­tions for use, i.e. an excep­ti­on, it must pro­ve that this is pos­si­ble in indi­vi­du­al cases wit­hout end­an­ge­ring the safe­ty of users, pati­ents or third par­ties, becau­se safe pro­duct use is gua­ran­teed even wit­hout ins­truc­tions for use. In addi­ti­on, ins­truc­tions for use may only be dis­pen­sed with if the pro­duct in ques­ti­on is used exclu­si­ve­ly by per­sons in the cour­se of their pro­fes­sio­nal acti­vi­ties and within the frame­work of pro­fes­sio­nal health­ca­re ser­vices. Use by other per­sons can­not reason­ab­ly be expected.

The ques­ti­on of whe­ther ins­truc­tions for use are dis­pensable must be con­side­red within the con­text of risk manage­ment. The risks that may be asso­cia­ted with the absence of ins­truc­tions for use must be asses­sed and eva­lua­ted. The decis­i­on to dis­pen­se with ins­truc­tions for use must be justified.

Digi­tal ins­truc­tions for use

Artic­le 3(1) of Regu­la­ti­on (EU) No 207/2012 (PDF) on elec­tro­nic ins­truc­tions for use for medi­cal devices (‘Regu­la­ti­on’) con­clu­si­ve­ly lists the pro­ducts for which elec­tro­nic ins­truc­tions for use are sufficient.

Spe­ci­fi­cal­ly, the­se are the fol­lo­wing products:

• acti­ve and inac­ti­ve implan­ta­ble medi­cal devices and access­ories inten­ded sole­ly for the implan­ta­ti­on or pro­gramming of a spe­ci­fic acti­ve implan­ta­ble medi­cal device;
• per­ma­nent­ly instal­led medi­cal devices;
• medi­cal devices and access­ories in which a sys­tem for dis­play­ing the ins­truc­tions for use is incorporated;
• stand-alone soft­ware.

If medi­cal devices other than tho­se men­tio­ned abo­ve are affec­ted, ins­truc­tions for use in ana­lo­gue form are still requi­red – unless ins­truc­tions for use can be dis­pen­sed with entirely.

The­re are also addi­tio­nal con­di­ti­ons for the pro­vi­si­on of elec­tro­nic ins­truc­tions for use ins­tead of paper ins­truc­tions for use. For exam­p­le, the risk assess­ment must show that the level of safe­ty when pro­vi­ding elec­tro­nic ins­truc­tions for use is at least as high as when pro­vi­ding ins­truc­tions for use in paper form. In addi­ti­on, the manu­fac­tu­rer must have a sys­tem in place that enables them to pro­vi­de the ins­truc­tions for use to the user in paper form free of char­ge and in a time­ly man­ner upon request. At the same time, addi­tio­nal requi­re­ments are impo­sed on chan­ge manage­ment and the time­line for main­tai­ning the digi­tal ins­truc­tions for use.

Con­clu­si­on and recom­men­ded action

Manu­fac­tu­r­ers of Class I and Class IIa pro­ducts may have the opti­on of dis­pen­sing with ins­truc­tions for use. The risks of doing so must be tho­rough­ly weig­hed up; the decis­i­on its­elf must be jus­ti­fied within the risk manage­ment pro­cess. The manu­fac­tu­rer is lia­ble for any poten­ti­al harm to users or pati­ents resul­ting from the wai­ver of ins­truc­tions for use.

The pro­vi­si­on of elec­tro­nic ins­truc­tions for use ins­tead of paper ins­truc­tions for use is only pos­si­ble in a limi­t­ed num­ber of cases. If a manu­fac­tu­rer deci­des to pro­vi­de the ins­truc­tions for use in digi­tal form only, addi­tio­nal spe­cial requi­re­ments must be observed.