Biotech Healthcare secures EU certification for ophthalmic device portfolio

Biotech Healthcare, an India-based medical device manufacturer with offices in Roscommon, Ireland, has achieved certification under the European Union's Medical Device Regulation across its range of ophthalmic and medical devices, supporting continued presence in the European market. The company holds MDR certification for devices manufactured in India across its ophthalmic and medical portfolio.

Ophthalmology Times Europe reported that the MDR, introduced to address safety gaps under the former Medical Device Directive, has changed how medical devices are evaluated, monitored and maintained throughout their lifecycle. The regulation includes requirements for enhanced clinical evidence, postmarket surveillance, oversight by Notified Bodies, traceability and transparency through the EUDAMED database.

The MDR-certified products include intraocular lenses, devices for intraocular surgery, capsular tension rings, iris retractors, ophthalmic strips, sterile ophthalmic viscosurgical devices, sterile solutions for osteoarthritis use, sterile ophthalmic solutions and sterile cross-linked hyaluronic acid gel for dermal use. The company noted that these certifications reflect compliance with MDR's enhanced requirements for safety, performance, clinical oversight and lifecycle monitoring.

Biotech Healthcare stated that MDR certification enables continued access to the European market without disruption, supports reinforced clinical confidence through validated safety and performance standards, and provides greater distributor confidence through portfolio stability. The company operates across ophthalmology, dermatology and orthopaedics, with products available in over 110 countries.

Last year, Biotech Healthcare launched its extended depth-of-field intraocular lens, Optiflex XTENSE Comfort Plus, at the 2025 European Society of Cataract and Refractive Surgeons Congress in Copenhagen. In a study of 30 patients with the lens implanted, 89.66 per cent exhibited uncorrected distance visual acuity of 0.0 logMAR or better.

Founded in India, the company has sales and marketing headquarters in Luzern, Switzerland, with additional offices in Roscommon, Ireland, and Ahmedabad, India, where research, development and manufacturing are conducted.

View the full details on the company's regulatory compliance strategy.