The Euro­pean Union reached a pro­vi­sion­al polit­i­cal agree­ment on the text for the pro­posed revi­sion of the EU’s Prod­uct Lia­bil­i­ty Direc­tive (PLD) in Decem­ber last year. The pro­posed updates to the direc­tive aim to align it with advance­ments in tech­nol­o­gy by broad­en­ing its scope to incor­po­rate soft­ware, for exam­ple AI.

In addi­tion, for intri­cate cas­es, the bur­den of proof will be placed on prod­uct providers, rather than con­sumers, to sim­pli­fy the process of fil­ing claims. These changes will enable con­sumers to make claims more efficiently.

Under the exist­ing PLD, a claimant needs to prove that the prod­uct is faulty and that the dam­age was caused by that fault, known as the casu­al link. Under the agreed revised PLD, for sci­en­tif­i­cal­ly or tech­ni­cal­ly intri­cate cas­es, where it is prob­lem­at­ic for the vic­tim to prove lia­bil­i­ty, con­sumers can rely on the pre­sump­tion of the link between the defect and damage. 

Also, under the exist­ing PLD, cus­tomers have to file a claim with­in ten years, oth­er­wise that right is gone. This is espe­cial­ly dis­tress­ing for med­ical con­di­tions, where symp­toms are slow to appear. In the agreed revised PLD, the expiry date has been extend­ed to 25 years. This will prove dif­fi­cult in real­i­ty because staff changes, and com­pa­nies will lose estab­lished knowl­edge. Med­ical device com­pa­nies will have to pro­duce a sys­tem to doc­u­ment in the present, that a device is not defec­tive, for the future. 

Con­sumers now have an eas­i­er process for mak­ing claims, which has led to a change in the bur­den of proof on com­pa­nies. As a result, many cas­es will like­ly be resolved out of court to pre­vent com­pa­nies from fac­ing poten­tial finan­cial or rep­u­ta­tion­al dam­age. Set­tling such claims goes against the basic prin­ci­ples of the med­ical devices and IVD med­ical devices reg­u­la­tions (MDR and IVDR) because the aim is not to inves­ti­gate the root cause of the dam­age but to evade a pro­longed legal process. As a result, the qual­i­ty, safe­ty and effec­tive­ness of the device are not eval­u­at­ed dur­ing the procedure. 

Source: Medtech Insight (an Infor­ma product)

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

Browse web­site by key­word “Leg­is­la­tion Documents”