VOC limits and indoor air quality standards like M1, EC1+ and the Nordic Swan Ecolabel are shaping what goes into products and how they're assembled. For medical device teams, that sits alongside requirements they already manage closely, such as ICH Q3C guidelines on residual solvents and California's Proposition 65.

What's actually changing

The regulatory shift in the Nordics isn't just about tighter limits. It's about direction. REACH enforcement is intensifying and regulations across Sweden, Denmark and Norway are all increasing transparency requirements. Customers in the region increasingly request full documentation: SDS, LCA data and certification readiness as standard, on top of the regulatory files device manufacturers already maintain for markets like the US.

For adhesive users, the practical implication is this: solvent-based systems that were compliant five years ago may no longer be, or require more documentation to prove they are.

Where adhesives fit into the compliance picture

Adhesives are a small part of most medical device assemblies by weight, but they can be a significant source of VOC emissions. In patient-contact applications, that isn't only a compliance question. Residual solvents are one more variable to account for on skin, which matters directly for wearables worn over days, wound dressings, ostomy flanges and incise films.

Solvent-free formulations, such as solvent-free UV acrylic technology, address this on both fronts. They deliver ultra-low VOC levels that simplify documentation, and they remove residual solvents from the adhesive layer altogether. Solvent-free coating also removes the energy needed to dry and treat solvents in production, which lowers the CO₂ footprint of the process. These advanced acrylic adhesive systems can also be formulated with moisture vapor transmission rates suited to wearable and long-wear applications.

Making the transition practical

The business case for switching isn't only regulatory. For teams under pressure to demonstrate sustainability progress alongside clinical performance, the emissions and documentation profile of solvent-free UV acrylic technology is an auditable improvement, not just a claim.

The transition requires upfront evaluation. Substrate compatibility, application conditions and performance requirements all need to be mapped against existing device validation. But for most standard applications, including incise films, wound care dressings, surgical drapes and tapes, wearables, ostomy flanges and NPWT, solvent-free alternatives exist that match the performance requirements of the systems they replace.

Watch the full session

We covered the regulatory landscape, real-world application scenarios and the decision criteria for transitioning to solvent-free systems in a recent webinar. The regulatory and technology story applies directly to medical device manufacturing.