miraDry secures EU MDR Certification and expands use across Europe

miraDry®, Inc., a global leader in underarm sweat and odor treatment, announced today it has now obtained CE marking for the miraDry system, under the European Union’s Medical Device Regulation (EU MDR 2017/745), along with expanded clearance for the reduction of underarm sweat, odor, and hair. The company also gained approval for software that reduces total treatment time by up to 30%, enhancing both patient comfort and clinic efficiency.

miraDry is now offered by hundreds of providers in 14+ European countries and has helped over 500,000 patients globally. With this clearance, miraDry provides a faster, more complete solution to three of the most common underarm concerns, in one non-surgical treatment.

Securing CE mark under the new MDR process, with expanded indications for the miraDry system reflects our commitment to high-quality innovation,” said Robert Catlin, Chief Executive Officer, miraDry. “We’re proud to deliver a long-term, proven solution to address growing demand for underarm sweat, odor and hair reduction in Europe —while driving value for providers.”

Demand for lasting underarm solutions is surging. Europe’s deodorant market is projected to reach $16.15 billion by 20311, with 50+ million consumers in the UK alone buying deodorants regularly. Meanwhile, laser hair removal in the region is expected to grow to $1.22 billion by 2032, with underarms among the top areas treated.

“This certification underscores miraDry’s clinical performance and regulatory strength,” said Irene Mo, Vice President of Quality and Regulatory at miraDry. “We’ve built a technology that meets the rigorous international standards, and safely delivers long-lasting relief from sweat, odor, and hair.”

miraDry remains the only FDA-cleared and CE-marked system for permanent reduction of sweat, odor and hair follicles, now backed by EU MDR certification and improved treatment delivery. miraDry has proven to reduce odor in 97% of treated underarms, with 89% of patients no longer bothered by underarm odor. miraDry’s unique mode of action is skin and hair color agnostic, unlike laser hair removal devices, and has proven to reduce hair by 70% in skin Fitzpatrick types I-V.