Spain pub­lished a 36-page Roy­al Decree, PS 1/2023 in the Span­ish Boletin Del Esta­do on 21 March, which sum­maris­es how the country’s med­ical device reg­u­la­tions may dif­fer from require­ments in oth­er EU countries. 

The doc­u­ment is aimed at con­tend­ing with areas that are the respon­si­bil­i­ty of indi­vid­ual nation­al author­i­ties in the EU, for instance repro­cess­ing and in-house man­u­fac­ture. Oth­er sub­jects are also cov­ered, some of which could appear sur­pris­ing diver­gences from oth­er EU coun­tries. Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR) per­mits nation­al deci­sion-mak­ing, with­in cer­tain lim­its, on the fol­low­ing: a) reg­u­la­tion of sin­gle-use devices b) reg­is­ter­ing dis­trib­u­tors c) des­ig­nat­ing and mon­i­tor­ing noti­fied bod­ies d) mar­ket sur­veil­lance e) fees and f) sanctions. 

The doc­u­ment is cru­cial for any com­pa­ny con­duct­ing busi­ness in Spain. 

It includes prac­ti­cal tem­plates for: pre-mar­ket license appli­ca­tions, reval­i­da­tions or mod­i­fi­ca­tions; and reg­is­ter­ing the appoint­ment of the tech­ni­cal man­ag­er – at the loca­tions of a man­u­fac­tur­er, sub­con­trac­tor or importer of med­ical devices or ster­il­i­sa­tion prod­ucts. Only prod­ucts that abide by both MDR stip­u­la­tions and this decree are per­mit­ted to be mar­ket­ed in Spain. The MDR is already direct­ly trans­posed in Span­ish nation­al law, a new law trans­pos­ing Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR) is going through a pub­lic con­sul­ta­tion in Spain at the moment. 

Man­u­fac­tur­ers for whom the Span­ish mar­ket is rel­e­vant should dis­cuss this top­ic with their local contacts.

Source: Medtech Insight (an Infor­ma product)