You may already have asked your­self how Brex­it may affect your busi­ness. This is a very com­plex ques­tion as it strong­ly depends on the role of your com­pa­ny, your over­all struc­ture and many more aspects.

Base case and polit­i­cal situation

To pro­vide a more prac­ti­cal approach, mdi Europa has set up a brief case study to make clear what chal­lenges may lay ahead depend­ing on the nature of your enter­prise. Assume you are a UK based med­ical device man­u­fac­tur­er of a class IIa prod­uct – what aspects would have to be regard­ed? Please find below some considerations.

At this stage, it is not clear yet, if the Euro­pean Union (EU) and the Unit­ed King­dom (UK) will come to an agree­ment with regards to the terms and con­di­tions of Brex­it.  This, in fact, is one of the biggest chal­lenges.  Giv­en the slow progress of nego­ti­a­tions, a “no deal” or non-reg­u­lat­ed Brex­it is becom­ing a more and more real­is­tic option.  Experts broad­ly dis­cussed the out­comes for the Euro­pean med­ical devices indus­try and it is evi­dent that the con­se­quences may be threat­en­ing to any com­pa­ny that fails to pre­pare for this worst-case sce­nario.  For this rea­son, com­pa­nies should plan on the assump­tion of a “no deal” Brexit: 

Chal­lenges con­nect­ed to Autho­rized Representatives

UK based man­u­fac­tur­ers either need to set up a loca­tion in the EU or to appoint an EU Autho­rized Rep­re­sen­ta­tive (AR) in one of the remain­ing EU countries. 

One legal con­se­quence of a “no deal” Brex­it would be that the UK would be con­sid­ered a “third coun­try”.  This means that accord­ing to the EU leg­is­la­tion on med­ical devices (Med­ical Devices Direc­tive 93/42/EEC (MDD), Active Implantable Med­ical Devices Direc­tive 90/385/EEC (AIMDD), In Vit­ro Diag­nos­tic Med­ical Devices Direc­tive 98/79/EC (IVDD) and sub­se­quent­ly Reg­u­la­tions (EU) 2017/745 and (EU) 2017/746 on med­ical devices (MDR) and in vit­ro diag­nos­tic med­ical devices (IVDR)), your com­pa­ny would either need to set up a loca­tion in the EU or to appoint an EU Autho­rized Rep­re­sen­ta­tive (AR) based in one of the 27 remain­ing EU coun­tries (EU27 coun­tries) to keep up your sales activities. 

Chal­lenges con­nect­ed to sup­ply chain

More­over, a “no deal” Brex­it would strong­ly affect the sup­ply chain.  Accord­ing to the MDR and IVDR, “‘dis­trib­u­tor’ means any nat­ur­al or legal per­son in the sup­ply chain, oth­er than the man­u­fac­tur­er or the importer, that makes a device avail­able on the mar­ket, up until the point of putting into ser­vice” where­as “‘importer’ means any nat­ur­al or legal per­son estab­lished with­in the Union that places a device from a third coun­try on the Union mar­ket“ (Source: MDR, IVDR). 

If, by the time of Brex­it, the UK will be con­sid­ered a third coun­try, EU27 based dis­trib­u­tors will, for UK based com­pa­nies, become importers.  Roles and respon­si­bil­i­ties of dis­trib­u­tors and importers dif­fer and not all your EU27 based dis­trib­u­tors might be able or pre­pared to act as importers for your prod­ucts as well.  In addi­tion, it is not clear yet, in how far future tar­iff reg­u­la­tions or reg­u­la­to­ry dif­fer­ences may dis­rupt sup­ply chains. 

Chal­lenges con­nect­ed to Noti­fied Bodies

By the time the UK leaves the EU, UK based NBs will lose their accred­i­ta­tion and CE cer­tifi­cates issued by UK NBs will become void. 

Anoth­er big issue that comes with a “no deal” Brex­it con­cerns Noti­fied Bod­ies (NB) and CE cer­tifi­cates.  By the time the UK leaves the EU, UK based NBs will lose their accred­i­ta­tion and CE cer­tifi­cates issued by UK NBs will become void.  This means that man­u­fac­tur­ers who would like to con­tin­ue sell­ing their devices in the EU27 coun­tries after Brex­it, must des­ig­nate a NB who is locat­ed in one of these coun­tries and thus is able to issue a valid CE certificate. 

Vice ver­sa, it is advis­able to observe the reg­u­la­to­ry devel­op­ment in the UK.  Although the UK plans to fur­ther accept CE marked prod­ucts after Brex­it for a lim­it­ed peri­od of time, the UK will devel­op an own reg­u­la­to­ry regime with its own require­ments.  Cer­tain­ly, non-UK man­u­fac­tur­ers who want to sell their prod­ucts in the UK will need to appoint a “UK Respon­si­ble Per­son”, a role that is close­ly aligned to the EU Autho­rized Representative. 

Last, you should review the cer­tifi­cates of your (crit­i­cal) sup­pli­ers, sub­con­trac­tors and, if applic­a­ble, orig­i­nal equip­ment man­u­fac­tur­ers (OEM). Cer­tifi­cates from a UK NB issued for one of your sup­pli­ers, sub­con­trac­tors or OEMs will become void as well post-Brex­it – a EU27 based NB most prob­a­bly wouldn’t issue a CE cer­tifi­cate for you if your sup­ply chain does not com­ply with EU legislation. 

The points above list some of the main points that should be regard­ed. If you have any spe­cif­ic ques­tions relat­ed to this top­ic, please don’t hes­i­tate to get in touch!

Sources: Guid­ance on the reg­u­la­tion of med­ical devices in a no-deal Brex­it. Read full doc­u­ment “Fur­ther guid­ance note on the reg­u­la­tion of med­i­cines, med­ical devices and clin­i­cal tri­als if there’s No-Deal Brex­it on the UK Gov­ern­ment web­site.

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