Drafts for the new Machi­nery and AI Ordinance

Effects on ope­ra­tors of pro­duc­tion faci­li­ties and tech­ni­cal equipment

Machi­nery Direc­ti­ve 2006/42/EC (MRL) (PDF) was in clear need of revi­si­on. Many of the revi­sed defi­ni­ti­ons make the Direc­ti­ve more com­pa­ti­ble with the new legis­la­ti­ve frame­work. Like­wi­se, in my view, an expan­si­on of the risk-based approach bey­ond the health and safe­ty requi­re­ments pre­vious­ly con­tai­ned in Annex I of the MD into the area of digi­ti­sa­ti­on and net­wor­king was more than neces­sa­ry to encom­pass the incre­asing legal uncer­tain­ties in the mar­ket rela­ting to the­se ele­ments of any modern manu­fac­tu­ring struc­tu­re. The­se regu­la­ti­ons are pri­ma­ri­ly aimed at manu­fac­tu­r­ers of machi­nery and the other pro­ducts cover­ed by the new ordi­nan­ce. We have alre­a­dy pro­vi­ded details of the regu­la­ti­ons in our news covera­ge.

By con­trast, the­re is sur­pri­sin­gly litt­le dis­cus­sion of the impact on ope­ra­tors of the new Machi­nery Ordi­nan­ce and, becau­se it is inte­gral to the defi­ni­ti­on of arti­fi­ci­al intel­li­gence sys­tems, the AI Ordi­nan­ce. It can be assu­med that many com­pa­nies use machi­nes in their manu­fac­tu­ring faci­li­ties, inte­gra­te them into alre­a­dy exis­ting sys­tems and/or also col­la­bo­ra­te in Indus­try 4.0 net­works.

The­se com­pa­nies are regu­lar­ly not addres­sees of the MD and will also not fall under the new Machi­nery Ordi­nan­ce. Howe­ver, it is fre­quent­ly over­loo­ked that, even in the curr­ent­ly appli­ca­ble ver­si­on, the ques­ti­on of signi­fi­cant modi­fi­ca­ti­ons to a machi­ne has a long histo­ry of deba­te bet­ween legis­la­tors, acci­dent insu­rance pro­vi­ders and ope­ra­tors. The term has been the sub­ject of two dif­fe­rent inter­pre­ta­ti­ve papers by the Fede­ral Minis­try of Labour and Social Affairs and its respec­ti­ve pre­de­ces­sors in Ger­ma­ny in the last 15 years alo­ne. The objec­ti­ve was to enable ope­ra­tors to assess a tech­ni­cal modi­fi­ca­ti­on to a machi­ne. If a modi­fi­ca­ti­on was then so serious that the manufacturer’s ori­gi­nal con­for­mi­ty assess­ment was no lon­ger com­ple­te, the ope­ra­tor beca­me the manu­fac­tu­rer of a new machi­ne with all the resul­ting obli­ga­ti­ons.

The­se regu­la­ti­ons of the Fede­ral Ministry’s 2015 inter­pre­ta­ti­ve paper (only in Ger­man) curr­ent­ly form, at least in Ger­ma­ny, the basis for an operator’s decis­i­on as to whe­ther modi­fi­ca­ti­ons initia­ted to an exis­ting machi­ne must lead to a reas­sess­ment of the product’s con­for­mi­ty.

The new Machi­nery Ordi­nan­ce defi­nes a sub­stan­ti­al modi­fi­ca­ti­on in the draft text, which is curr­ent­ly only available in the ori­gi­nal Eng­lish lan­guage:

”’sub­stan­ti­al modi­fi­ca­ti­on’ means a modi­fi­ca­ti­on of a machi­nery pro­duct, by phy­si­cal or digi­tal means after that machi­nery pro­duct has been pla­ced on the mar­ket or put into ser­vice, which is not fore­seen by the manu­fac­tu­rer and as a result of which the com­pli­ance of the machi­nery pro­duct with the rele­vant essen­ti­al health and safe­ty requi­re­ments may be affec­ted”.

Befo­re loo­king at the impli­ca­ti­ons of this defi­ni­ti­on, I think it is worth loo­king at the defi­ni­ti­on of arti­fi­ci­al intel­li­gence sys­tems. The defi­ni­ti­on is broad and iden­ti­fies three ways in which soft­ware can be unders­tood as an arti­fi­ci­al intel­li­gence system:

  • any type of machi­ne learning
  • logi­cal structures
  • sta­tis­ti­cal methods

If you look at the cur­rent pro­duc­tion land­scape, you will find the lat­ter two defi­ni­ti­ons on at least most of the machi­nes used the­re. If we then com­bi­ne the defi­ni­ti­on of sub­stan­ti­al modi­fi­ca­ti­on and that of arti­fi­ci­al intel­li­gence sys­tems, it very quick­ly beco­mes clear that any use of moni­to­ring sys­tems on machi­nes, sen­sor tech­no­lo­gy, pre­dic­ti­ve ana­ly­tics as part of pre­dic­ti­ve main­ten­an­ce, auto­ma­tic sort­ing of defec­ti­ve parts, defect detec­tion based on opti­cal inspec­tion sys­tems – all con­sti­tu­te a sub­stan­ti­al modi­fi­ca­ti­on and an arti­fi­ci­al intel­li­gence sys­tem.

The fre­quent con­se­quence is the­r­e­fo­re that a con­for­mi­ty assess­ment pro­cess again beco­mes neces­sa­ry, not by the manu­fac­tu­rer, but by the ope­ra­tor. As a rule, the lat­ter will not be able to make this assess­ment for the machi­ne its­elf, and even less so for the added soft­ware, which is clas­si­fied as arti­fi­ci­al intel­li­gence in the AI Ordi­nan­ce.

Whe­ther, under the­se cir­cum­s­tances, ope­ra­tors will still be able to deploy expe­di­ent sys­tems like the ones men­tio­ned abo­ve wit­hout a lot of effort and expen­se is, in my opi­ni­on, less likely than befo­re.

Whe­ther the objec­ti­ve of the Machi­nery Ordi­nan­ce will real­ly have a bene­fi­ci­al effect may be doub­ted. Deli­be­ra­ti­ons are under­way on the Machi­nery Ordi­nan­ce as well as on the draft AI Ordi­nan­ce. Atten­ti­on should be paid to the broad defi­ni­ti­on of a sub­stan­ti­al modi­fi­ca­ti­on as well as the broad defi­ni­ti­on of an arti­fi­ci­al intel­li­gence system.


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