Michael Fink, CEO (Credit: Mask Logic)

Mask Logic achieves CE Certification for its 3D-printed custom-fit respirator

Mask Logic is now certified to sell its bespoke reusable respirator – bringing personalised protection and comfort to the PPE ...

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Mask Logic is now certified to sell its bespoke reusable respirator – bringing personalised protection and comfort to the PPE face mask market.

Innovative Scottish company Mask Logic has achieved CE certification for its custom-fit, reusable half-mask respirator. This is a major milestone that enables the product to be sold in the UK and the EU and it marks the transition from breakthrough concept to market-ready launch.

CE certification is the manufacturer’s declaration that a product meets all relevant EU safety, health, and environmental requirements, a critical step for any product intended to safeguard workers in high-risk environments. It also represents a defining move towards Mask Logic’s mission to make PPE personal, inclusive, comfortable, and easier to wear correctly over long periods.

Across industries such as construction, manufacturing, energy, and healthcare, workers often rely on off-the-shelf respirators that are built around average head forms. This coarse sizing can result in discomfort from pressure points around the nose and cheekbones, and inconsistent sealing. Routine ‘comfort breaks’ where users loosen or remove masks undermine both protection and compliance.

Mask Logic’s mission is to overcome issues of oversimplified sizing and poor fit. Initiated during the Covid-19 pandemic by a team of scientists, engineers, and medical experts, the company’s half-mask respirator uses 3D scanning and 3D printing technology to create a precise map of the face within minutes. A quick face scan with a phone app maps the individual’s facial contours. The map is then used to design and manufacture a customised nose bridge and seal – improving fit where discomfort and leakage are most common. Mask Logic is building on the momentum of its commercial trials in Scotland, and plans to expand sales across the UK and into Europe. To support this growth, the company is developing commercial relationships with a mix of established respiratory equipment manufacturers and distributors, supporting customers from SMEs to large organisations and accelerating entry into new sectors and regions.

Mask Logic’s newly certified respirators mask being comfortably worn in the workplace. (Credit: Mask Logic)

Michael Fink, CEO of Mask Logic, said: “Following extensive trials, getting this certification is a huge milestone for Mask Logic. It proves our respirator meets the performance standards required for protection against real-world hazards. More than a validation of performance, it marks a step change in how users can experience respiratory PPE with the help of modern technology. We treat comfort and individual fit as essential to safety, not optional extras.

“Discomfort isn’t a minor irritation – it’s a genuine safety risk. If you want someone to use something every day, it must be comfortable. When a mask hurts or doesn’t fit properly, people adjust it, loosen it, wear it incorrectly, or remove it early. A personalised fit reduces the need to overtighten straps to get a seal, easing pressure on the skin and supporting consistent use over long periods. The history of protective equipment and devices is full of examples where comfort plays a huge role in adoption, for example seat belts or bike helmets.”

The British Standards Institution recently launched BS 30417:2025, a new guide urging employers and suppliers to provide inclusive PPE that fits a diverse workforce, regardless of gender, ethnicity, body shape, age, or disability.

Fink continued: “Regulation is now moving towards inclusive PPE. Our custom-fit model is aligned to that shift. We are already seeing strong interest from employers who want to go beyond compliance and give their teams protection they can wear properly and comfortably – and we’re ready to support that change at scale. Personal kit creates personal ownership, and personal ownership drives safer behaviour.”

Designed, produced, and shipped from the company’s headquarters in Edinburgh, the current scan-to-delivery process for the respirator takes two to three weeks. Mask Logic is developing future models to support the rollout to large workforces with remote sizing.

Backed by seed funding from Scottish investors, the company is positioning itself for growth through 2026 as demand rises for PPE solutions that protect all employees equitably.

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