Man­u­fac­tur­ers have had to bear the expense of pur­chas­ing Euro­pean stan­dards and their updates for many years, regard­less of their size or turnover, but that is set to change. The Euro­pean Court of Jus­tice (ECJ) has ruled in a land­mark judg­ment that Euro­pean har­monised tech­ni­cal stan­dards should be pro­vid­ed free of charge to all, as they form part of EU law.

Reg­u­la­tions, direc­tives, and asso­ci­at­ed rules, includ­ing amend­ments, are acces­si­ble in the Offi­cial Jour­nal of the Euro­pean Union. Guid­ance is also pro­vid­ed on the Euro­pean Commission’s web­site. How­ev­er, the glitch aris­es from stan­dards used in New Approach reg­u­la­tions that apply to var­i­ous indus­tri­al sec­tors, includ­ing med­ical devices. Charges are imposed despite their sig­nif­i­cance to man­u­fac­tur­ers as a tool for demon­strat­ing com­pli­ance with regulations.

A har­mo­nized stan­dard is one that man­u­fac­tur­ers can use to demon­strate com­pli­ance with the Gen­er­al Safe­ty and Per­for­mance Require­ments (GSPR) of an EU reg­u­la­tion. For the field of med­ical tech­nol­o­gy, these tools are essen­tial for com­pli­ance with the Med­ical Devices Reg­u­la­tion (MDR) and the In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (IVDR). Man­u­fac­tur­ers have the option to devi­ate from a har­monised stan­dard, but if they do, they must find anoth­er jus­ti­fi­able method to demon­strate con­for­mi­ty with the GSPRs.

So far, the ECJ rul­ing does not clar­i­fy whether there will be a cost for inter­na­tion­al stan­dards har­mo­nized by the EU. 

Source: Medtech Insight (an Infor­ma product)

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website