Spain’s only Noti­fied Body, based at the Span­ish Agency of Med­i­cines and Med­ical Prod­ucts (AEMPS) reg­u­la­to­ry agency, which is des­ig­nat­ed under the EU Med­ical Devices Direc­tive (MDD) and In Vit­ro Diag­nos­tic Med­ical Devices Direc­tive (IVDD), is not accept­ing requests for cer­ti­fi­ca­tion of med­ical devices under the MDD for new cus­tomers as and from 1 June 2019 and appli­ca­tions for cer­ti­fi­ca­tion of new prod­ucts from exist­ing clients from 31 July 2019. 

For Span­ish com­pa­nies that have not already start­ed work on com­pli­ance with the new Med­ical Devices Reg­u­la­tion (EU) 2017/745 (MDR), this is a big blow. They will now have the obsta­cle of look­ing for a Noti­fied Body that has the facil­i­ty to take on a new client and the added dif­fi­cul­ty of func­tion­ing in a for­eign language. 

Despite the Euro­pean Com­mis­sion being con­fi­dent that the new Reg­u­la­tions can be imple­ment­ed on time, two Noti­fied Bod­ies are already restrict­ing activities

AEMPS has not been des­ig­nat­ed under the MDR and it is not clear if it even applied. As yet, only 2 Noti­fied Bod­ies have been des­ig­nat­ed-BSI UK and TÜV SÜD. BSI UK mean­while made sim­i­lar restric­tions regard­ing time­lines for MDD cer­tifi­cate exten­sions. So despite the Euro­pean Com­mis­sion being con­fi­dent that the new Reg­u­la­tions can be imple­ment­ed on time, two Noti­fied Bod­ies are already restrict­ing activ­i­ties in an effort to com­plete its work­load relat­ed to the cur­rent MDD by the date of full appli­ca­tion of the new MDR. 

The MDR, which ful­ly applies from 26 May 2020, has a dero­ga­tion exten­sion or grace peri­od (arti­cle 120.3), which com­pa­nies can use to con­tin­ue plac­ing cer­tain devices cer­ti­fied under the MDD on the mar­ket until 26 May 2024 at max­i­mum. The prod­ucts that can avail of the grace peri­od can only do so if there are no major changes in their design and intend­ed pur­pose. They must also meet the require­ments of the MDR con­cern­ing post-mar­ket sur­veil­lance, vig­i­lance and reg­is­tra­tion of eco­nom­ic oper­a­tors, instead of the cor­re­spond­ing oblig­a­tions in the Directives.

Source: Medtech Insight (an Infor­ma product)

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