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Mr. Peep Peterson Minister of Health and Labour Suur-Ameerika 1 10122 Tallinn Estonia Brussels, 26 October 2022 Re: Impiementation of the EU Medical Device Regulation 74512017 (MDR) — Urgent Need for Legislative Action Dear Minister Peterson, As industry Ieaders of the medical technology industry, we would like to reiterate our serious concerns regarding the current impiementation status of the Medical Devices Regulation 2017/745 (MDR). Unless immediate action is taken, Europe faces a scenario where a high number of existing medical devices, upon which patients, hospitais and other health institutions rely, wiII fail to be re-certified on time and therefore risk to permanently disappear from the market. At the same time, certification of new and improved products is also delayed, resulting in delayed patient access to the benefits of innovation. We therefore caII upon you to urgently support and introduce measures of legislative nature (i.e., via formal amendment of the MDR) to safeguard the continuity of patient care across Europe and the world. After more than five years of impiementation, the MDR regulatory system stiil Iacks sufficient certification capacity needed to certify 1) Existing devices that have been on the market for years and that are required to undergo re certification under the Regulation by no later than 26 May 2024 and 2) New or significantly changed devices. There are around 25,000 certifications under the former Medical Devices Directives covering hundreds of thousands of existing devices. As of today, only a small fraction of these former certifications has been replaced with the needed MDR certifications. To make things worse, more and more of these former certifications are expiring, with two thousand expiring now in 2022, double that amount in 2023, and more than seventeen thousand expiring in the first four months of 2024. The ongoing COVID-19 pandemic and the war in Ukraine have exacerbated this situation by creating supply chain disruptions, issues with conducting on-site audits and with clinical investigations. Since the EU Employment, Social Policy, Health and Consumer Affairs Council meeting of June 2022, national regulatory authorities in the Medical Devices Coordination Group have proposed 19 (non legislative) measures via the paper MDCG 2022-14, which are designed to free up some Notified Body capacity. .)UCaIm)nIsteerium SAABUNUD Although we welcome this rapid work, it is our unequivocal assessment that these 19 solutions are insufficient. They only partially address the structural issue of Notified Body capacity, and they fail to directly address the growing emergency of expiring certifications. They also fail to provide a workable regulatory pathway for new devices whose technological innovation can bring needed solutions to Europes pressing healthcare challenges. Legislative solutions are therefore needed as soon as possible, in addition to the non-legislative work conducted thus far. Specifically, we urge the EU institutions to take legislative action to: (1) Extend the validity of the Medical Devices Directive and Active Implantable Medical Devices Directive Certificates: to maintain access to existing devices. These extensions should be given in a similar manner to the January 2022 amendment of the in vitro Diagnostic Medical Devices Regulation, i.e. with different deadiines for each device risk class. (2) AIIow conditional!temporary MDR certification: to maintain access to existing devices, substantially changed and new devices, for example by allowing time to finish compiling further data/evidence needed to meet MDR requirements (3) Abolish the MDR Article 120(4) ‘warehousing’ deadiine: to aHow the continued sale of existing devices beyond the May 2025 end-date, provided that they are manufactured before the 26 May 2024. This wiII allow to avoid needless disposal of devices aiready placed on the market. We strongly encourage you to swiftly embrace these measures, but also to continue working to strengthen the role of Europe as an attractive region of the world for investments in medical technology innovations. This could be achieved by setting as a priority timely patient access to best-in-class breakthrough technologies which address unmet medical needs through clear regulatory pathways. Taking into account this situation, we, the signatories of this letter, caII on you to work on concrete legal solutions that allow us to comply in time with the new MDR requirements. We stand ready to collaborate, to individually meet with you and discuss solutions that address the many complex challenges. Best regards, Please note: we are sending this same letter to fellow Ministers across the European Union Karim Mansour Senior Vice President, Heatthcare, EMEA Antonio Sanchez Migatton 3M Administrador Sotidario Juan Antonio Matachana Aramburu Akus innovation in Anaosthesia Consejero-Oetegado/Chief Executive Oftlcer Antonio Matachana Rick Aguitera President / Chief Executive OfIlcer Aaren Sclentlfic mc. Mauro Beccaro Mag. Ruth Fischer Managing Director Chief Executive Offlcer. AL.CHI.Ml.A SRL Unternehmensteitung Apomedica Pharmazeutische Produkte GmbH Jorge Fernandez Sophie DutiLloy Administrador President, International VC Franchise Stefan Krupp AB Medica Group Alcon Management S.A. Managing Director Arthrex EMEA Arthrex GmbH // Maja Weiss Dr. Germano Natali Chief Executive Offlcer Chief Executive Offlcer ABENA HELPI d.o.o. Alfasigma Espata, S.L. Etena Civantos EVP Management ARW Technoiogles / / Peter Butterfietd Chief Executive Offlcer »7or4J Sunita Mochintva AHiance Pharma p(c Managing Director Danny Forde ACE Medical Ltd Director of External Retations & 4ki Business Devetopment Atlantic Therapeutics Cks Fred nk J nsson Chief Executive Offlcer Alteco Medical AB Chris Smith President Geoffrey Stevens Acumed iberica 4 Senior Vice President EMEA & Asia Pacific AtriCuro Europe B.V. ATROPYN Ltd Nina Settberg Chief Executive Offlcer Adnane Belhaj Addi MedicaLAB Chief Executive Oftcer Maria Da Costa Das Dores amb consult sas Chief Executive Officer Atropyn Ltd GS3tI701 ‘‘. tM1I() tI,KTA Pascal Juery t A4O)’IG) Chief Executive Officer AhatAtper Kilinc — Agfa-Gevaert Group President Emilio Barta Anadolu T.p Vicepresidente Finanzas y Control Europa Attindas Hygiene Partners, Spaln b2294I2M •rur PEDoJo SAIAIAR A4*447M) — Pedro Jose Salazar Sategui Chief Executive Officer Antoni Cartes Bosch AJL Ophtalmic SA Chief Executive Offlcer Dieter Krines Ancar VP and General Manager, Europe Avanos Medlcal  Stefan Meyer Regional President CommerciaL Eva Galik and Wolfgan Hansen Peter Bulte Operations EMEA Co-Chief Executive Offlcers Chief Executive Offlcer Bayer Consumer Care AG, Bitop AG AVIZOR Consumer HeaLth (7 • Louise Meiners Torsten Kullrnann Managing Director Roland Goette bon OptlcVertrlebsgesellschaftmbH EVP, President EMEA aXcentrnedlcalGmbH Fpr,iiato di talmente da SILVANO ERTASINI - Data. 13/tO/2022 OS:242 Emil Billback Orla Connaughton chtef Executive officer Silvano Bertasini Founder Et VP Regulatory and Bonesupport AB Amministratore Delegato e Clinical Affairs General Manager Aztec Medical Ltd. Beckman Coulter Srl Rudolf Mad Manag,ng Dtrector Dr. Meinard Lugan Nick Soubry S0h11 GmbH u. Co. KG, Member of the Board B. Braun Chief Executive Officer erre c Familienholding Verwaltungs SE Belgian Optlcal Supply B. Braun SE 1 Eric Thepaut Anders Göransson President EMEA Chief Executive Officer Xavier Garcia Ordonez Chief Executive Officer Boston ScIentifc Bactiguard AB Better Care / . . Giusto Bonandrini Nico(as Coudurier Chief Executive Offlcer Joan Pares Chief Executive Offlcer Burke Li Burke S.p.A. Chief Executive Offlcer Biocodex Bama Import Medlca Garth Barnard Asier Albtzu Managing Director Joseph C. Papa General Manager Cantor+Nissel Limlted, UK Chief Executive Otflcer Biolan Health Bausch+Lomb Jorge Sahlieh - International Direct Markets President Ignacio Bailön Villoria Cardinal Health Cristiano Franzi Chief Executive Offlcer SVP & President EMEA Bioner Baxter Healthcare SA Dr. Alexander UhI Justus Felix Wehmer Chairman of the Executive Board / Member of the Board / Chief Financial Offlcer Chief Executive Offlcer Carl Zelss Medltec AG BIOTRONIK SE & Co. KG  — Michael Yarrow Par-Ola Larsson Karim Bitar Managing Director VD-Chief Executive Officer Chief Executive Officer CarpoNovum AB Dermal Labo,atorles Limited Convatec Pic - Ines Riedel Chief Executive Officer Alex Moussa Bill Doherty Catgut GmbH Senior Vice President and General Executive Vice President EMEA Manager of EMEA Cook Medicai Dexcom mc. c.,.’ .... ,ö .I•. J O Christoph Miethke O L Chief Executive Offlcer Bart Meermans Christoph Miethke GmbH @ C0.KG President & Chief Executive Offlcer Cooper Consumer Health SAS Marc Julien Chief Operating Offlcer DiabeLoop Michael Robinsohn Holly Sheffield General Manager Europe President CooperSurgical, mc. Church & Dwight coopersurgical Fernando Davico ChiefVice President Sales, EMEA, APAC & LATAM for DiaSorin SpA DiaSorin S.p.A. Ahmet Ozcan Debbie Olive Sole Representative President EMEA CIDSpa Coopervision 4j L Massimiliano Boggetti — Chief Executive Officer Jashwant Sharma, MD Jacob Paul Diesse Diagnostica Senesa S.p.A. Owner and President Chief Executive Officer ClMATechnoiogy,mnc. Corin Group — Alberto Aguilar Montoro Davin Wain Chief Executive Officer Santiago Rubin de Celis Managing Director DigitaiAnatomics Managing Director Cuxson Gerrard & Co Ltd. V CimbIs Orthodontlcs / - / Maria Daniela Rinaido General Manager Jarmila Melinec JesösCastariön Rodriguez D.R.M.S.L.R. Prokuristka Director General DIPROS d.o.o. Chnica y Controi 07 V Robert McGregor Hans Winklmann Eduardo Jorge Baguero Managing Director Geschaftsfuhrender Gesellschafter / Director General Contamac Ltd Chief Executive Offlcer Direx Danumed Mcd izlntechnik GmbH  Sofia Svanteson Nikos Vasileiou VO Vasileiou & ASS Co founder, Elsa Science AB Bsc Optometrist Pedro A. Monta nes Gutierrez EYEART Laboratorles Karageorgiadis Chief Executive Offlcer Diseho y Aplicaciones del No Tejido %--t Juliän Rodriguez Fernändez 4p— Mario Renou Chief Executive Offcer Managing Director Stephan Kohorst Eyetech CLM Ltd Emergencla 2000 Executive Partner Dr. Ausbfittel Ei Co 4fl /‘ / Miguel Lopes da Cunha / Pål Ryfors Chief Executive Offter Chief Executive Otlcer Fapomed Dispositivos Mdicos S.A. - Episurf Operations AB Jean-Philippe Massardier Prsident DirecteurGöneral DTF Medical / Diifusion Technique (2 Franaise Dr. Angela Sauerwald Dr. Marc Vollenbroeker VP Product Safety, Clinical and Managing Director Regulatory Affairs Farco-Pharma GmbH Essity Hygiene and Health AB OJlåAC.1Å&flSfl Jeremy Eakin MIETrAkuINANLx) Chief Executive Offlcer flIRFCT0R - Eakln Healthcare huRNE S pA Dott. Gino Zabban Ferdinando Mietta Amministratore Unico Managing Director FARMAczABBANS.p.k - EUROCLONE S.p.A. JesusTobosoRamön / Director General ‘••) Eckermann lmplant Leyre Ruele Ibarrola Viflceflzo Maglione Chief Executive Ofllcer Chief Executive Offlcer Eversens FARMACEUTICI DAMOR S.p.A. Marc Oczachowski President & Chief Executive Officer -“ O Ld,v EDAPTMS /— Foto,’,, o DennisHöjer Dr. Ladislav Grad Chief Executive Officer Chief Executive Ofhcer -- •.. ‘ FOTONAd.o.o. •:‘ - EvimeriaEMRAB Lenart Girandon Chief Executive Offlcer EDUCELL d.o.o. Egon Wiest Dr. Katarzyna Mazur-Hofsaess \ Jean-Luc Lemercier Director ewlmed GmbH Chiet Executive O(flcer Care Enablement & Member ot the Managemeni Board Fresenlus Medlcal Care AG Ei Co. KGaA Corporate Vice President EMEACLA & JAPAC Edwards Llfesclences SA Jos Sagarminaga - Managing Director Exactech lberica Blorn Gross Head of Finance & HR Fuhrmann GmbH Gonzalo Maroto Giuseppe Campora Country Manager Chief Executive Oftlcer Elekta Eye Pharma SpA  HlII.RomS.pA. Ferran Soler Pedrerol Javier Schmidt Reparaz Strategic Business & PM BU Manager Chief Executive Officer Maurizio Fumagalli Medical Systems Division Grupo Kalma Amministratore Delegato FuJifiim Hiil-Rom S.p.A. FoBeni Managing Director Maurizio Foroni Gruppo Bioimpianti SrL Legal Representative Jan Langenbach G21 S.rJ. Managing Director HMT Medlzlntechnlk GmbH A’ \(/ Andrew Sette WernerTscrian Dr Roaflno Tupynamua rvllgeec(.. D t VP 1 n tI R egu lat ory Chairman of the Board of directors Geschaftsfuhrer / Chief Executive Officer Galifa Contactllnsen AG Hoffrlchter GmbH HaemonetI S.A. Stefan Kremer 1Ojflo/f4, / - Dipl..WrtscI.Ing., MBA vorstand / CO Rob Walton Stefan Kremer President & Chief Executive Officer for Filippo Lanzi Board Member / COO Europe, Middle East and Africa President of EMEA & LatAm Region Human Optlcs GE HealthCare Haleon - t ‘‘-“.‘ William Lee, PhD PiotrHammer President “ Chief Executive Offlcer ICARESMedIcus,Inc. Monica Renata Lorenza Sordi Hammem’ied Medical Poiska sp. Chief Executive Officer 20.0. SKA General Medlcal Merate S.p.A. 02S093385 RJCARDO D ANDE$ R B8395OS6} “‘ ‘—“ Johan Falemark Ricardo de Andres de Francisco Director General jji VD,President, PDG lcu Mcd Ical Iberia Dr. Matthias Schmidt Chief Executive Offlcer Gimmi GmbH /4 /1r -— Nicole Petermann President Francisco Javier Nicols Linares Heraeus Medlcal GmbH Administrador Unico Robert Olsson Igrobe Rodar 2001 GysAB 1 Jög Wieczorek ;1L ‘) Chief Executive Offlcer Annette Brodin Rampe HERMESARZNEIMITTELGmbH Chief Executive Offlcer ImaglneCare AB Guy D’haeseleer EMEA Business Leader, Gore & Associates Gore Oscar Martinez Jordan Jens Sass Managing Director Chief Executive Offtcer & Shareholder Herslll lmplantcast GmbH  Ezio Poretti Chief Executive Offlcer Luis Gerardo Mateos Garnica Kardia SRL Lechoslaw F. Ciupik Director General Ch ief Executive Oflicer/Prezes Zar2adu inmet Gamick LfC Sp. Z 0.0. V4±ttw. Karl-Christian Storz Jan De Witte Managing Director President & Chief Execulive Officer KARL STORZ SE & CO KG Integra LifeSciences Lluis Duocastella Chief Executive Officer Lue Vascuiar Devices Blotech Maria Elena Gumä Anja Sraj Chief Executive Offlcer Procurator QMR Katia Dental Fredrik Löf 1NTERDENT d.o.o. Chief Executive Officer Llfectean internationa AB A / Regina Kirchner-GottschaLk Managing Director Massimo Galafiore Luis Garraida KIRCHNER &WiLHELM GmbH + Co. KG Chief Executive Officer Chief Executive Officer Llmacorporate S.p.A. Intra-Lock iberia Markus Puchleitner Stephen Cox Head of Controlling and Sourcing, Chief Executive Officer, Co-Founder Proxy Hoider inVera Medicai Limited Kwlzda Pharma GmbH Manuel Rodriguez Chief Executive Officer. Technical Director Ftrnm gwtMrrwiP LIO w1w:o (aII.;uw CM Cr. iii Linear Chemicals o, fl Domenico Ganassini di Camerati President Aiberto Bueno Gallego istituto Ganassini S.p.A. di Ricerche Chief Executive Oflicer Biochimiche Laboratorios Saivat, S.A. / Gunilla Eriksson Gavin Wood Company Group Chairman, MedTech EMEA Johnson &Johnson fr Javier Camps Chief Business Offlcer Managing Director Llnk Sweden AB — Laboratorios Urgo Damien McDonald Chief Executive Ofllcer LivaNova Anna Rameback VD ,Journaiia AB Juan M. Diaz General Manager LeMaitre Vascuiar Spain Iberia J(c :-v/ - ‘ Wolfgang Sussle Chief Executive Qfflcer Martin Hovestadt Lohmann & Rauscher GmbH & Co. KG Geschftsfuhrer / Chief Executive Offlcer Jike Systemtechnlk GmbH Jesus Garcia Guijo Chief Executive Olllcer Lexei  PjRtOOYO.RH ..‘.s;FwAs& L Thomas Reins Eng. 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Dr. Silvia Heise-Grubner Geschäftsföhrerin Primary i Consumer Care Robert Heavyside MEDICE Arzneimitte( GrnbH President Dr. Stefan Koch Österrelch Medmont International Pty Ltd. Chief Executive Officer MCM Ktosterfrau Vertrjebs GmbH Rob ten Hoedt MikaeL Paulsson Executive Vice President & President, Tommaso Ascione Managing Director Giobat Regions Chief Executive Offlcer Medicinsk Bildteknik Sverige AB Medtronic Plc. MD TECH S.R.L TLJRE —— ) kL- -J-. Martin Lehner Chief Executive Offlcer Joaquin Carreras Gimenez Director General Andrea Zanardi Menarlni Diagnösticos MedI-Giobe Technologles GmbH Managing Director MEDA Pharma S.p.A. (a Viatris Company) Kevin J Mitchell Mats Weibull Managing Director Chief Executive Officer Dr. Alfred Stett Menicon Limited Monomak Medical AB Chief Executive Offlcer Okuvislon GmbH Jose Miguel Carvalho Barbosa Chief Executive Officer Multiorthos, Lda Atsushi Yamashita President Menicon SAS Miquel Angel Garcia Managing Director MSD Olympus Europa SE & Co. 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Laboratorio Farmacologico Paul Martingeli SyP Region Head Europe Sanofi Consumer Healthcare tAO!4flr ‘OO.6)(A S p * N,O, U*4),L,OO. fti.VtI*’I.IC Ma rco Perego Amministratore Unico e Legale Ralf Klein Rappresentante Geschäftsfuhrer/ Chief Executive Offlcer Paola Oddenino Permedica spa Radimed GmbH President SapiMedSPA vEid A&A) Mikael SaLg Carlota Fernändez Durn Svend Andersen Directora General Chief Executive Offlcer Executive Vice President & President Sapio Life Rekal Svenska AB Consumer Self-Care International Perrigo Lucile Biaise President-SLeep & Respiratory Care Friedrich Schmitz Thierry Herbreteau Resmed Geschftsfuhrender GeseLLschafter / Chief Group Chief Executive Officer Executive Officer Peters Surgical SCHMITZ u. Söhne GmbH & Co. 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