PFAS Compliance in Medical Devices: A Regulatory Imperative for Manufacturers

Understanding PFAS in Healthcare

Per- and polyfluoroalkyl substances (PFAS) have long been integral to the performance of medical devices due to their resistance to heat, chemicals, and biological interactions. They are found common in catheters, surgical instruments, and diagnostic systems.

However, increasing scrutiny from global regulatory bodies—particularly in the EU through initiatives like REACH Annex XV—is driving the industry toward PFAS elimination due to their environmental persistence and potential health risks.

Compliance Challenges for Medical Device Manufacturers

PFAS regulations are evolving rapidly, requiring manufacturers to:

• Identify PFAS usage in device materials and components
• Assess substitution potential without compromising product performance
• Manage compliance across global supply chains
• Document and report usage accurately
• Stay aligned with dynamic regulatory frameworks like REACH, TSCA, and EPA mandates

Saraca’s PFAS Compliance Framework for Medical Devices

At Saraca, we help manufacturers future-proof their medical devices with a strategic, data-driven approach to PFAS compliance.

1. PFAS Detection & Material Assessment

• Chemical Composition Analysis: Precise identification of PFAS across device BOMs using analytical and documentation-based methods.
• Regulatory Mapping: Aligning findings with EU REACH proposals, TSCA inventory updates, and global regulatory limits.

2. Alternative Material Evaluation

• Technical Feasibility Studies: Assessment of PFAS-free substitutes and their impact on device performance and patient safety.
• Design Compatibility: Evaluating how material changes affect mechanical, thermal, and functional specifications.

3. Supplier Coordination and Data Management

• Supplier Data Collection: Facilitating transparency in PFAS-related declarations and validations from component vendors.
• Documentation Alignment: Supporting manufacturers in creating traceable, audit-ready compliance records as per ECHA and other regulatory standards.

4. Risk Analysis & Public Consultation Support

• Impact Assessments: Assisting with the social, economic, and technical evaluations required for regulatory submissions.
• Commentary Preparation: Supporting Annex-XV public comment drafts with structured, data-driven inputs.

5. Testing & Verification

• Lab Partnerships: Collaborating with accredited laboratories for PFAS concentration testing and material validation.
• Compliance Checks: Ensuring new materials or redesigns meet safety, regulatory, and performance benchmarks.

Why Choose Saraca for PFAS Compliance?

• Domain expertise in regulated medical devices
• Cross-functional teams covering engineering, regulatory, and materials science
• Experience in navigating global compliance frameworks
• Support for full lifecycle compliance—design, documentation, testing, and reporting

Contact Saraca to assess your device portfolio and begin your PFAS compliance journey today.