Document 8RZ8dryZ7z8m281Gvoj1BKoM5

Ref. Ares(2023)3666686 - 26/05/2023 Contents Who we are Role of medical technologies Vision for the Chemicals Strategy for Sustainability and the revision of REACH Case studies 2 About MedTech Europe The Europeantrade association for the medical technology industry including diagnostics, medical devices and digital health. OUR MEMBERS SClRaTng EassO ociationE s EE OO A iar About medical technology Medical technology is any technology used to save and improve lives of individuals suffering from a wide range of conditions. 02 There are more than 500,000 products, services and solutions . currently available . aa RMT ee LEE ai Role of medical technologies ---- Essential to the proper runonfiEurnopeg's hospitals, testing laboratorie and medical clini In Vitro Diagnostics (IVDs) Detect, manage, and correct conditions, allowing us to get back to our Rn & Medical Devices (] PE (MDs) ` , MedtechEure Vision for the Chemicals Strategy for Sustainability and the revision of REACH 10 Sustainability as the way forward We support the goals of the Green Deal, and the Chemicals Strategy for Sustainability Sectors like ours must do their part to contribute to the goals of more sustainable use of chemicals and reducing its environmental footprint We are committed to meeting these goals, whilst preserving access to medical care and technologies that save, extend, and maintain quality of life Need of a balance between: 9achievable objectives 9fair expectations 9conditions and timelines that correspond to the realities in which the medical technology industry operates 9product performance should not be compromised by phasing out essential hazardous substances 11 simplification EES Ropsiseney i nes [rel C-r~ [a-- SpipEnoE . Siemans | eouserconn| "omer om pi Lom PCorPnciiepctt,etGalial[| [["pheirfnorlmlanycle, | Mneeeednmeddtioebralin)g |frsopeeciiiatouideteord| VJEosimCvlnCieeTnd | iBrntensiievetotreing, fl oMieLEarpetSdsoiasSver rpirveen [p[iepyisveedrtlilel (Rgereeiot)y fe lvoreetnnl [| "in:te pets MedTech Evopo Case studies 15 TT _--_-- Case study -- Microplastics The IVD sector contributes 270 kg/year of microplastics released to the environment (that is, less than 0.1% of all microplastics use) Redesign involves extensive development, testing, revalidation and regulatory approval of the design changes under the IVR. This is a process that can take up to 5-12 years for Proposfyed REACH Restriction on [EQITHEIEVECE Clg + Ceaocmhplpiraondcuectcosts for companies in the sector, would be equal to 8,683 billion over 20 years, if conditional derogations would notapply. microplastics RACOpinion trae une2020,poge55 painniscathlatSaordeWpraessteentonFeuesveadnttirseslueeassoe pwiapwesa.Y MfionroIrcEornotpraibsuitcess Tdenrciovsemertoimc pcrtohdeurcutssoesr kemedicinalproductsandmedicaldevices andInvitro agnosticmedical devices,Releases 3 MedTech Evope EEE ie sea Case study -- OPE/NPE REACH LAUT EERIE Ba An estimated 700 tonnes/ annum of OPEs used by other industries. The IVD industry was estimated to use 40 tonnes For an IVD test reagent it is not possible to know if an alternative will work until feasibility testing is complete (1-2 years) - per product In some cases, some MedTech Europe members are re- designing hundreds of reagent products, tying up the R&D tefaormupsto 12years MedTechEurope Case stud--y Lead and lead components ae P p[v, ee . A (= B fa r Ee i Be] MedTechEurope oF [----T--1--8 SLL - : r. | Eh | Concluding remarks Tosaressthe: challenges the sectorhsfacedwith REACH fCuhteurmeicoapportunities with more sustainable use of > spofte hemedicc altechi logese sector > time 8resources neededtofindaematives > lo1wbrqiunagnptritoideusctussemdcoomcpaamprleadncoethwietrheseoguractesonneeded Wsepirnrocoaglepganceyeragppysr:oaech or spelconsiderationfor + RDperosotdrruiccttidoenssigannsd.3nAdutnhtritaotloengsacyonplryoduacpepslyantdopanreew + SCfoobnrniidetawuraoptrnoodnu(cwthtdeheer.seignUssme,ac/hsdcueafslfiilcnyi'enptoetsyisem.ee)ioSgfraaknmeteeddneftosor ehtogies and sectors legion % MedTech Europe I Thank you! i A--" www.medtecheurope.org ww MedTechEvope E-- E ----