Document ODJXrRdB7VYR1D3JYMdreNy1

PFAS in the medical technologies sector MedTech Europe's preliminary views on the Restriction prepublication , Chemicals Manager MedTech Europe 30 March 2022 Contents About the medical technologies industry Uses and role of PFAS in medical technologies PFAS Restriction dossier - preliminary views Conclusions 2 About MedTech Europe The European trade association for the medical technology industry including diagnostics, medical devices and digital health. OUR MEMBERS 140+ multinational corporations* *medical devices, diagnostics and digital health 50 medical technology associations 3 Specificities of the medical technology sector About medical technologies Over 500,000 products, services and solutions are available Medical devices (e.g. surgical equipment, hospital beds, contact lenses, (active) implantable devices) IVDs (e.g. reagents, assays, analytical instruments) Sectoral legislation MDR/IVDR Medical technologies are invasive and/or come into contact with the human body and are strictly regulated for their safety, design, performance, quality, risk management Certain requirements exist for the justification and labelling of chemicals used in medical technologies Complexity of technologies & supply chain Individual devices differ greatly in complexity; it is not uncommon for routinely used devices to have hundreds and thousands of components and parts E.g. laboratory/diagnostic machines for blood testing and analysis Supply chains of up to 30 tiers from materials to the final device exist The average depth is smaller (e.g., four to six tiers for a seemingly simple product like an elastic bandage) 4 PFAS in the medical technology sector Why PFAS Properties such as chemical and heat resistance, lubrication and biocompatibility PFAS is either a component of the final medical device or IVD, or a processing aid used during upstream manufacturing PFAS substances are often key to achieving the required high performance and durability of the products in the various use areas 5 Alternatives Without PFAS, these medical technologies would not be able to perform their intended purpose Sometimes, the alternative is another type of PFAS the functionalities of PFAS make them preferred over alternatives A non-PFAS would likely lead to e.g. discontinuation of life saving procedures (e.g. stenting, heart valve repairing and replacement, catheters, implants, and capital equipment used in related procedures) and IVD uses (e.g. instruments, IVD testing kits) increased incidence of puncture wounds increased incidence of device malfunction and the inability of the surgeon to sufficiently visualize the surgical site inability to manufacture critical medical technologies Examples of where PFAS can be found in Medical Devices and IVDs Medical Devices Ophthalmic endotamponades - in surgery to reposition a detached retina Blood contact invasive devices - e.g. grafts/covered stents, catheter tubings for infusion of medication and IV fluids and drug eluting stent (DES) - blood flow within/between arteries and veins and for DES to control drug release to inhibit the vessel re-narrowing Medication contact components - minimise drug-device interactions Surgical sutures: pledgets made of PTFE serve as suture abutments when suturing soft tissue. They are essential in heart valve operations Fluoropolymers, like PTFE and PVDF, are used in several components for the treatment of serious acute and chronic diseases In hernia meshes for rapid healing of hernia Cleaning of medical devices as cleaning solvents in vapor degreasing applications IVD Instruments & Reagents IVD testing kits for hemostasis products which detect blood coagulation Heat-transfer agent in IVD clinical chemistry diagnostic testing instruments, which is essential to the functioning of the instrument Surfactant properties in in vitro diagnostic assays, which allow measures of various parameters such as magnesium concentration in serum, plasma and urine Fluoropolymers like PTFE and PVDF are used in several components for analytical instruments In device part of an integral drug-device combination Other: Coating on the dispense tip, tubing and tubing connectors, distributors, seals and gaskets, syringe pump valves, O-rings and sealants 6 MedTech Europe's Preliminary Views on the Pre-publication Dossier MedTech Europe welcomes the (conditional) derogations proposed for the many essential medical technologies using PFAS Laboratory diagnostics are given a derogation, though some IVD uses fall out of the scope Multiple medical device derogations are `to be confirmed' after the public consultation Even if IVDs and medical devices obtain the necessary derogations, we rely on our suppliers to also have derogations, for the components, they supply us with No derogations are proposed for longer than 13.5 years, this creates the assumption that everything can be substituted and that is not the case, e.g. no alternative for PTFE The challenge with a long list of derogations for uses we stated as known, is that the list is not exhaustive The multiple regulatory initiatives running in parallel (PVC, BPA, PFAS, etc.) lead to substitution requirements that are heavy on R&D 7 Actions foreseen by the medical technology sector Collecting data in order to substantiate the `conditional' derogations. Assessing whether: There are missing derogations for IVDs and medical devices. There are missing derogations for components that our suppliers supply us with (e.g. lubricants, PCB, other electronics). Working with our value chain: end users to understand if there is more that can be done on the reporting requirements/ end-of-life management of PFAS-containing technologies e.g. in hospitals, laboratories. supply chain to understand what a realistic transitional period is needed for the components identified to be containing PFAS. partner associations globally to collect data and communicate the impact. 8 Concluding remarks PFAS are used in a range of critical medical technologies Due to the expected broad impact of the PFAS restriction, numerous technologies and services could be affected in parallel PFAS often have no alternative, and where there is, it tends to be another PFAS We are working to collect additional data to support the dossier submitters' work and ensure continued access to medical technologies We are engaging with our value chain: global network, end-users and supply chain to understand better how to strengthen communication and actions on PFAS-containing medical technologies When considering a transition to a potential nonPFAS alternative, it is important to consider patient well-being and the timeline and requirements under sectoral legislation 9 Thank you! @medtecheurope.org www.medtecheurope.org (\7'PM, edTech Europe from diagnosis to cure