𝗣𝗙𝗔𝗦: 𝗧𝗵𝗲 ‘𝗙𝗼𝗿𝗲𝘃𝗲𝗿 𝗖𝗵𝗲𝗺𝗶𝗰𝗮𝗹𝘀’ 𝗛𝗮𝘂𝗻𝘁𝗶𝗻𝗴 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 ⚠️
Per- and polyfluoroalkyl substances (PFAS), or family of “forever chemicals”, that make medical devices more durable, biocompatible, and resistant to degradation, are on the chopping block.
Yesterday, BSI conducted a webinar on PFAS and their impact on the MedTech industry in Europe. We'll link to our own PFAS resources in the comments of this post. Clearly, there are growing regulatory restrictions in Europe and public health concerns are putting manufacturers in a difficult position. Regulators are moving fast, and the device industry is facing a massive challenge.
𝗪𝗵𝗮𝘁’𝘀 𝗮𝘁 𝘀𝘁𝗮𝗸𝗲?
– 𝗕𝗮𝗻 𝗼𝗿 𝗕𝘂𝘀𝘁? Europe is pushing for a full ban, while the US is rolling out a patchwork of state and federal crackdowns. Exemptions for medical devices? Maybe... but unclear.
– 𝗦𝘂𝗽𝗽𝗹𝘆 𝗖𝗵𝗮𝗶𝗻𝘀 𝗨𝗻𝗱𝗲𝗿 𝗙𝗶𝗿𝗲 – 3M, DuPont, and other PFAS giants are pulling out due to legal pressure. Even if regulators allow PFAS in medical devices, will manufacturers even be able to source them?
– 𝗡𝗼 𝗘𝗮𝘀𝘆 𝗥𝗲𝗽𝗹𝗮𝗰𝗲𝗺𝗲𝗻𝘁𝘀 – PFAS-free alternatives must withstand extreme sterilization, resist biological degradation, and maintain clinical safety and performance standards. Finding a substitute isn’t just hard, it’s a significant regulatory challenge.
– 𝗗𝗲𝘃𝗶𝗰𝗲 𝗦𝗵𝗼𝗿𝘁𝗮𝗴𝗲𝘀 𝗜𝗻𝗰𝗼𝗺𝗶𝗻𝗴? If bans move forward without transition periods, some critical devices may disappear from the market. The industry is caught between compliance and patient care.
– 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗠𝗶𝗻𝗲𝗳𝗶𝗲𝗹𝗱 – Any material swap could trigger MDR/FDA recertification, new clinical evaluations, and years of testing. A single material change could cost millions and delay market approvals.
– 𝗖𝗼𝗻𝗳𝗼𝗿𝗺𝗶𝘁𝘆 𝗔𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁 𝗖𝗼𝗺𝗽𝗹𝗲𝘅𝗶𝘁𝘆 – Even minor material changes can trigger substantial design modifications, requiring new clinical evaluations, biocompatibility testing, and regulatory submissions. For MDR-certified devices, this can be a time-intensive and costly process.
𝗪𝗵𝗮𝘁 𝗰𝗮𝗻 𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗲𝗿𝘀 𝗱𝗼 𝗻𝗼𝘄?
✔ Audit supply chains – Where is PFAS hiding in your products and processes?
✔ Talk to regulators – Engage with notified bodies before the wave hits.
✔ Find alternatives, start testing – The clock is ticking, and last-minute changes mean costly delays.
✔ Prepare for turbulence – This shift isn’t just compliance; it’s a fundamental industry shake-up.
The PFAS storm isn’t a question of ‘if’—it’s ‘when’. 𝗧𝗵𝗼𝘀𝗲 𝘄𝗵𝗼 𝗽𝗿𝗲𝗽𝗮𝗿𝗲 𝗻𝗼𝘄 𝘄𝗶𝗹𝗹 𝗹𝗲𝗮𝗱 𝘁𝗵𝗲 𝘁𝗿𝗮𝗻𝘀𝗶𝘁𝗶𝗼𝗻. Those who wait risk losing market share, product lines, and regulatory approval.
𝗛𝗼𝘄 𝗰𝗮𝗻 𝗥𝗤𝗠+ 𝗵𝗲𝗹𝗽?
We'll link to many of our PFAS resources in the comments! Please reach out to us directly if you're a manufacturer who needs to act – we can help.
#MedTech #PFAS #RegulatoryAffairs
