Document DvrQnQjkV17jx8vZ1v083eaLN

MEETING WITH DG GROW Medical Devices: EU Investments in R&D Challenges and opportunities THE EU CHEMICAL STRATEGY aims to achieve a toxic-free environment with a high level of protection of human health & the environment |coci } Key messages + The medical devices industry is aligned with the css oabnjdecetnivviersonmoefnta high level of protection of human health + Tgheenemraetdeica1l00debviilcleison inrdeuvesnturey ewimtphloypsrod3u0c0tKiownorkfearcsi.lities in + EGuurropienvaensdtmeinntvsestin8%inonfovastailoens vsoalveumeliviensReb. E"uTrhoeprea eavreeryabyoeuatr 5(0105/m9i)llion radiological inaging procedures in "Euhrboopuet 2 milion patients receive radiation therapy every year in + We71a0r.e000piToVnDeetresstsinarceiprecrufloarrmedeceovneormyyseacnodndsuinbsEtuirtoupteion of + cOuhremidceavliscesofccoonntcaeirnn linited volumes of hazardous sbausbtstapnecrefsormwahnenceno alternatives are available to achieve + Tomovation needs a pragmatic legislative approach adapted COCIiRr|COCIR 00. COCIR is the European Trade Association representing the medical imaging, \4 Ta |2 > sonore te + Radiotherapy Sm + HealthiCT + Electromedical + tn Ewope, around 500000 workers are a ------ Ain soto --ba) ---- | LE.ad than 250people. + The global market for medical equipment is wEourrotphe,1a0n0dbilolfionthwisith2a0robuinldion28fobrillCiOoCn IiRn ae | C= oS. ELE Ba ew cocir"see) Co MEDICAL IMAGING and THERAPY DEVICES [( Sx -- al! Ce) TI _ voTsOmMoOnGReAmPsHsYon L FT ft _-- toy WS $(aSwy a 1) acctienaton OP am ED) i 00 `cociQn | 0C0-O7 CR Complex products wi.th long supply chai. ns te a Fo Ci Typical MRI unit weighs abo 10utot ns == 32,76,00000asssuebm-balsiseesmblies * 120,000 component parts = More than 1,000,000 "articles" ) A $e inte Ei re oRae Meta ul U = ra TypiRcoaolts1u1p,0p5l0 yuppclherasinacthoassth5e wtoord7 levels #10different languages . High value devices, low unit sales numLsbuipeptlrieesrspurchasing leverage even on 1 evel \ =]1 FR So W=a] o am = = 2 0 ioe EoAy Sarit INNOVATION MEANS SAVING LIVES + With an annual growth rate of 5% and investments in R&D representing umErpaetiao n8t%aonodfvstnaeliaevsthevoFlaCunmTde,asrmeveadirmcaaln Industry sectors in Europe and globally. rman pert The medical sector is also the first in Saving he es o mprng he + New technologies contributes to woquralldi.ty of life for people around the Pe | VJ u AY Ex n) )q WdsiRE)) a 5 3 (A3 SAEg] Et BS A Hy x > I, ud LA ro. av Ra ES oy a I PN -- = -- 4 E VL reS m ten NL Lee |coci} INNOVATION IS A COMPLEX AND LONG PROCESS [Sre----_ [sgpeene<, tthieon7s0o5f7 scanner, / ~J 7 years design cycle for imaging 20 years for IVDs 11 years for radiation therapy 10 years of market availability o%0 THE EU CHEMICAL POLICY AND INNOVATION IN THE MEDICAL DEVICES SECTOR |goci<eD cocir | THE EU CHEMICAL POLICY SEE CE ET Wl asta BOMcheckznet = & Lo ry +*e} Bomcheck: The most effective way to lo comply with the SCIP database Urseegdulbatyedthsouusbasntdasnceosf minanmuiflalcitounrerosf epanrdtssuppliers to track Multiple emails to each supplier Centralised system : = == == =n | pal Ele Flr 80%ofthe 6 million submisstiotnhse SCIP database have been sent through REE ] oo < COCIR oo2 BOMCHECK and NEW SUBSTANCES + When a new substance is added to the list of regulated ones anywhere in the world BOMCheck Team assess the uses. + + The substance is added All suppliers are notified to to tuhpedanteextthreeilredaescelaorfaBtiOoMncshien cBkOM(c3hmeocnkt.hs)T.he request is then propagated to the supply chain that still do not use BOMcheck. (in total 5k-10k) + Ittakes 6 months to start getting information on uses. + Some critical uses may be identified too late to request exemptions. + Despite using the most advanced tool, it is impossible to collect complete information on uses/applications in the short time normally given for consultations (3-6 months). o%0 coci+ro} oe. MN Substitutiitnigng subSubstances in the medical device sector .} Gomopfaheltecshnooygy i ure safety, + ToSruabnsiiiuaonndrehqiucirpeesoootromf iamne caned sresourcss, inform of engineers, resoarchars and technicians | == a Fs `EE = = [=] EE] EEr=h { E=s=l=} 5 E Cp53 Lipii) {-] = o E= A r -- F-- = Et tephtholotesin highvoltageCT cables = = CEE] Ek [==] <D CcoOcCiRr (Oo WHAT INNOVATION NEEDS et ET " memne restrictions not to TTT FIN em = Ss o0 ee COCIR 00; CASE STUDY --- ROHS EXEMPTIONS Innovation oz 7 -_ : . [Duration E a ; he) as E-- . x) <Q THE CURRENT CHEMICAL POLICY ENDS oo UP IN HIGH IMPACTS + one venetstn vinsted vo EERE 2.43 reduction olin on CC RE ial ------ Impact of RoWS 2010/2021 iin == = 00 *] PROPORTIONALITY IS CRITICAL (sa am dll Rsa.vsetisugticoan nwitthbleossnhearomfmulaalrternhatailvets,orw1hisamlvwraaysmmweenltcome, may however not an x) oe |SoeOSR ChemiLco al strategy for sustainability 1. cThoeicunrrent Chemical Polychanges to fast or complex medical 52 TihmpeacGtSSawsishesascmeesnlteorfaemetahosuErUeshiasmpiecraflorPmoedlyfor(nmdorustsuybasstanwcheosle Testiced ina shorter me) 0 cocivneel o==~N CONTINUING INNOVATION IN MEDICAL TECHNOLOGIES sIencnuorveatdiosnveninbyt:he medical devices sector cannot be 1. Longer transition times for new restrictions 2. Longer duration of exemptions/exclusions 3. Diendniovcaattieodncoasndt/bheenaelfthictaraendtoimpGaecttermaisnseessment on proportionality and mitigate undesired impacts However, what is really needed is: Limived to: An alternative solution to restrictions that can achieve the same environmental protection goals + Essential uses + Small quantities ++ TCoennthroorleldedScponednittionasnd USES '<Q |coci } Key messages + Tofheamehdiighcallevdeelvicoefspriontdeucsttiroynisofalhiugmannedhewailtthh thaendCSeSnviorbojnemcetnitves + TbhiellimoendicraelvendueevicweisthipnrdoudsutcrytioenmplfoaycsiliStOiKeswoirnkeErusr,opegenaendratienve1s0t0 8% of sales volune in RD Unhere are about 300 Ailiion sadiclogical imaging procedures in Europe V1i0b7o0u00"31m 5D tAeste' arepacients perfo=rmed everyasatsieocnond ithn Butope ine + Wo are pioneers in circular econony and substitution of chemicals + Gur devices contain Linited volumes of hazardous substances when + nIonnaolvtaetrionnatinveeesdsaraeparvaagmialtaibcleletogisalcahtiievvee baepsptroapcehrfoardmaapntceed to long & complex design cycles of medical devices 0 Oapkes : == Qraclas', obrigado Stic RTH