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In many places, the restriction of PFAS in medical technology is still considered a minor regulatory issue. However, this is a misconception. PFAS (per- and polyfluoroalkyl substances, a group of several thousand chemicals with extremely stable carbon-fluorine bonds that hardly degrade in the environment) are at the center of an ongoing EU regulatory process. The ECHA (European Chemicals Agency, the EU authority for chemical safety) is tasked with deciding on a restriction under the REACH Regulation (Regulation on the Registration, Evaluation, Authorization, and Restriction of Chemicals).
The scientific committees are expected to finalize their opinions by the end of 2026, after which the European Commission will make a decision. There is currently no blanket immediate ban in place. For medical technology companies, however, this is no reason to relax: material substitution, regulatory approval, and workforce planning must begin now. This is because there is already a shortage of skilled professionals capable of providing technical support for the substitution process.
Fluoropolymers (fluorine-based plastics such as PTFE, FEP, or PFA) are widely used in medical devices because they combine properties that are difficult to achieve simultaneously with other plastics. PTFE (polytetrafluoroethylene, also known as Teflon), for example, is highly chemically resistant, has low friction, and is easily sterilizable. These properties make fluoropolymers attractive for catheters, guide wires, tubing systems, seals, implantable components, fluidic systems in diagnostic devices, and barrier films in packaging.
However, a material change is not merely a purchasing decision. Replacement materials must be tested for biocompatibility, aging behavior, sterilization resistance, particle formation, and extractability. Additionally, material changes may constitute a significant product change as defined by the MDR (EU Medical Device Regulation) and trigger new approval procedures.
PFAS substitution is therefore a portfolio and resource project, and this inevitably makes it a personnel project as well. Companies that need to transition multiple product lines simultaneously require capacity in the areas of development, testing, and approval. In many companies, however, this capacity is already tied up in ongoing MDR projects.
In our consulting practice, we regularly observe that the need for specialized professionals in ongoing transformation projects is often underestimated. Three core profiles have emerged for PFAS substitution.
Materials scientists and polymer chemists evaluate substitute materials, conduct material testing, and oversee the manufacturing transition. Knowledge of biological safety assessment according to ISO 10993 (the international series of standards for the biological evaluation of medical devices), sterilization validation, and plastics processing is required.
Regulatory affairs specialists are needed well before market launch. They ensure compliance with regulatory requirements and coordinate approval procedures. Their responsibilities include assessing REACH requirements, communicating with regulatory agencies and notified bodies (accredited testing organizations that evaluate medical devices on behalf of EU authorities), and maintaining technical documentation.
Project managers with dual expertise in engineering and regulatory affairs coordinate the areas of R&D, quality management, procurement, manufacturing, and external partners. Their particular value lies in identifying conflicting objectives at an early stage.
These profiles are currently in particularly short supply. Companies are competing for skilled workers with genuine medical technology experience. In some cases, they are also competing with semiconductor and chemical companies, which face the same challenge of finding substitutes. Candidates with a combination of polymer science, regulatory affairs, or validation expertise have a significantly stronger negotiating position.
Companies that identify PFAS dependencies early on can secure a competitive advantage. They can identify critical products and supply bottlenecks before their competitors do, build their own material expertise, reduce risks associated with relying on a single supplier, and reserve testing and approval resources well in advance.
At the same time, however, there are also typical risks. For example, while substitute materials may pass laboratory tests, they may fail under sterilization or aging conditions. Regulatory authorities underestimate the impact of material changes, and the necessary documentation is often lacking. Concurrent product changes place a simultaneous strain on the research and development, quality management, and regulatory affairs departments.
For medical devices that are invasive or can be implanted, particularly long grace periods are under discussion. Current proposals call for up to 13.5 years, including a transition period. This is a relevant planning parameter, but it does not automatically alleviate the burden. PFAS substitution affects not only research and development (R&D), but also the areas of quality assurance (systematic quality assurance), the supply chain (from raw material procurement to the final product), purchasing, production, and product management.
The following steps are recommended for companies:
In our industries, we observe that the targeted development of key positions is often initiated too late. For candidates, however, there are clear paths to specialization: polymer science and fluorine-free material systems, regulatory affairs under REACH and MDR, extractables and leachables analysis (analysis of substances released from materials under real or simulated conditions), and cross-functional project management.
The restrictions on PFAS are not yet final, but the direction is already clear. For the medical technology sector, this means a substitution process spanning several years that will simultaneously place demands on materials development, testing, regulatory approval, and the supply chain. The bottleneck lies less in the availability of substitute materials than in the skilled professionals who can evaluate, validate, and ensure regulatory compliance for them.
Companies that combine inventory management, prioritization, and workforce planning now will gain a head start that will be nearly impossible to catch up with later. Furthermore, PFAS are likely not an isolated case but part of a broader trend toward the group-based regulation of persistent substances. For professionals, this means that those who specialize now will position themselves in a structurally growing field.
If you are looking for qualified and motivated specialists and executives for your company, we can support you with our specialized network. We are particularly adept at finding the right candidates for positions at the intersection of materials development, regulatory affairs, and quality management in the context of the PFAS transition. For over 15 years, the recruitment consultants at BESTMINDS have been filling vacancies in the medical technology, healthcare, life sciences / pharma, energy / utility, and IT / media sectors with a wealth of expertise and dedication. We find the right candidates for you in a fair, loyal, and discreet manner. Contact us for a no-obligation initial consultation so that we can fill your vacancies promptly and effectively.
