Document vBkVmDKpdLyymgx242zZEzz7E

| TDoG: MErNAVuIrReOlNCMioEbNaTnu Dordea aDinrdecGtroereCnirGcruolawrtEhconomy. sReervviiscieonEUofhtehaeltRhEcAarCeHsRyesgtuelmation: Ensuring the medical technology industrycan still Wpaer,ticauslasroimn-evitorfo tdheveickeesy(rIeVpDr)easenndtamteidviecsalofdemveidceisca(lMDd)efvoircpersofceosmsipoannalieusse,inhatvhee hEeUr,etion ad dveociidde aed tt o joir ntly wi riitmepm atoctyoe oun,tthn oeurEgUt enhtelaya lrtehqcl uaerset.ameetingtoproposeasolutionto TsthreatreegyvfiorsoSfiutsothaneinRabEiAliCtHy (RCSeS)g, uhals abortnoueigohofttnhf,oerwkaerydcahadlilsecnugsessiounndoveerrtthheeEeUssCehnteimailcaulsse Cthoantceaprte,pwriotvhentheessaeintmiatlofpohrassoecioeutty aofndthwehmeonstthhearremairuelnsoubsasftearnacletserbnyatoinvelsy.allowing uses Ashnalelfcfoicniseindterantdheeffofelcltoiwviengskcehyemisesuuens:der REACH, RoHS and CLP for medical devices + Medicaldevicesare regulated by EU sectoral regulations (MDR/ IVDR), both already considering the risk of the most harmful substances for humans and the environment for the whole lfe cycle. + MDs and IVDs are extremely complex systems with a direct impact on patients' health. Thespecificity of MDand IVDs is wanslated into extended timelines required to develop and validate product changes (up to 5 years) and new generation + Tpiromdeucitssn(euepdetod1.2iyneaorus)r. sector it takes a minimum 3 to years just to assess the suitability of alternatives in legacy products (testing, validation, recertification) and `even longer for new generation products. + Hazardous substances are often essentialto the functioning of these technologies yet are usually used in very low quantities, even as lowasonly a few gramsperyear fmoerdtihcealwdheovlieceEsU.toDbeerobgraotuigohntstofortheextmaernkdeetd. periodsoftime are essential to allow The pressure of the current system regarding hazardous substances, which cannot be aligned with the industrial reality of our sector, has already caused significant impacts on innovation and development of new technologies and it seems to be destined to get worse. CInomlminieswsiitohntphaertaibcoulvaer-lmyaenttthiiosnsedtpoaionftgst,heweerevuirsgieon,EUto iennsstuirtuetitohnast,foarndmetdhiecaEludreovpiecaens thefollowing is implemented: 1. RleesgtarciyctpiroondsuacntsdaAnutdhsoprairseaptairotns.only apply to new product designs and not to 2. cFoonrsnideewraptrioodnuctthededseisgingsn,csyculefoffmetidiimcceailisgtereacnhnntoetldofgoiressu.bstitutiontaking into 3. Tfhoartdeervoigdaetnicoencsollalteecrtdedotwhnrotuhgehltinhee. substitution process can beusedto apply une202 1 We, on our side, commit to implementing processes that ensure that for the most harmful substances - when technically, economically, and from a perspective of human health feasible, a) safer alternatives will be used in new product designs, and b) emissions from legacy products will be adequately controlled and gradually reduced. We sincerely hope our concerns will be taken into consideration to ensure the revised REACH regulation could achieve the stated goals while at the same time promoting innovation and accessibility of medical devices. Sincerely, SIEMENS Healthineers EMEA GE Healthcare Philips Standards Global Regulations & Boston Scientific Imaging Hardware Excellence IC/PI Systems 8 June 2022 2