MPO: REACH SVHC Compliance for Medical Device Makers
In a recent article for MPO, Nigel Syrotuck, Mechanical Engineer at StarFish Medical, breaks down REACH SVHC compliance for teams working with material suppliers and compliance questionnaires. He notes that while REACH and RoHS are well covered elsewhere, SVHCs rarely get a clear explanation, even though the term shows up constantly in supplier documentation.
Syrotuck explains that SVHC stands for Substance of Very High Concern for Authorization, and that it’s just one element of the broader REACH directive. He walks through the three lists a chemical can land on: the Candidate List (SVHCs), the Authorization List, and the Restriction List, and clarifies that each carries a different level of regulatory consequence.
The article highlights the practical significance of the 0.1% w/w threshold, using a capacitor as an example of how an “article” is defined for compliance purposes. Syrotuck notes that substances below this threshold can be disregarded, while those above it in any single article trigger action.
Importantly, the piece clarifies that crossing the 0.1% threshold does not automatically make a product non-compliant. Instead, it triggers a specific communication obligation under Article 33 of the REACH Regulation, requiring suppliers to disclose the substance’s identity to industrial and professional recipients within 45 days, free of charge. Syrotuck adds that SVHCs can still increase supply chain risk, since substances can later be escalated to the Authorization or Restriction Lists, and some customers may simply prefer SVHC-free alternatives.
Syrotuck’s broader takeaway is that SVHC and REACH requirements evolve as ECHA updates its lists, and that building a regular review cycle into a materials documentation process is the most reliable way for medical device teams to stay ahead of changes.
Explore the full discussion by visiting the complete MPO article.
About StarFish Medical
StarFish Medical is a full-service medical device design, development, and specialty manufacturing company headquartered in Victoria, British Columbia, with additional offices in Toronto and Irvine, California.
StarFish Medical works with founder-led start-ups and global enterprises across North America that need to navigate the complexity of building and launching regulated medical technologies. The company combines product design and development with quality and regulatory expertise and manufacturing readiness to help teams move from early concept through commercialization and scaled production. Its experience includes diagnostics, drug delivery, surgical, therapy, and remote devices.
Founded in 1999, StarFish Medical has grown into Canada’s largest full-service medical device design, development, and commercialization partner. It operates as part of StarFish Holdings, which also includes ViVitro Labs, a global cardiovascular device testing company with facilities in Victoria and Marseille, France. In 2020, StarFish Medical led a multi-company Canadian team that updated the Winnipeg Ventilator to address COVID-19 supply chain and operational challenges.
Empowering Medtech Innovation®. starfishmedical.com
Contact Patrick Dean, Director of Marketing, for media inquiries.
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