Biotech Healthcare secures EU MDR certification for ophthalmic and medical devices

Biotech Healthcare announced that it has achieved certification under the European Union’s Medical Device Regulation (MDR) across a range of ophthalmic and medical devices, supporting its continued presence in the European market.¹

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 life cycle, according to the company. The regulation includes requirements for enhanced clinical evidence, postmarket surveillance, oversight by Notified Bodies, traceability, and transparency through the EUDAMED database.¹

Biotech Healthcare holds MDR certification for devices manufactured in India across its ophthalmic and medical portfolio. The MDR-certified products include intraocular lenses; devices for intraocular surgery; capsular tension rings; iris retractors; ophthalmic strips; sterile ophthalmic viscosurgical devices (sodium hyaluronate and chondroitin sulfate); sterile solutions for osteoarthritis use; sterile ophthalmic solutions (sodium hyaluronate, hydroxypropyl methylcellulose, silicone oils, perfluorocarbon liquids); and sterile cross-linked hyaluronic acid gel for dermal use.

Implications of MDR compliance

The company noted that these certifications “reflect compliance with MDR’s enhanced requirements for safety, performance, clinical oversight, and lifecycle monitoring.” Biotech Healthcare also noted 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.”¹

Last year, Biotech Healthcare launched its extended depth-of-field intraocular lens (EDOF IOL), Optiflex XTENSE Comfort Plus, at the 2025 European Society of Cataract and Refractive Surgeons Congress in Copenhagen, where clinicians reported their surgical experience with the device.^2,3

Dr Ozcan said the lens offered “very good near distance and intermediate vision,” without dysphotopsia or other visual disturbances.^2,3 According to Biotech Healthcare, other clinicians reported outcomes consistent with the lens’ design, which provides “a purely refractive optical profile that avoids diffractive rings, delivering high-definition vision across near, intermediate, and distance without compromise.” In a study of 30 patients with the lens implanted, 89.66% exhibited uncorrected distance visual acuity of 0.0 logMAR or better, 68.97% showed uncorrected intermediate visual acuity of 0.0 logMAR or better, and 86.2% had uncorrected visual acuity of 0.1 logMAR or better. At 3 months postoperative, patients demonstrated an extended range of vision greater than 3 D at 0.2 logMAR or better.^2,3

Biotech Healthcare operates in ophthalmology, dermatology, and orthopaedics, with its products available in over 110 countries.⁴ Founded in India, the company has sales and marketing headquarters in Luzern, Switzerland, and additional offices in Roscommon, Ireland, and Ahmedabad, India, where research, development, and manufacturing are conducted.⁴

References

1. From crisis to compliance: How Biotech Healthcare advanced in Europe’s toughest regulatory era. News release. February 16, 2026. Accessed February 16, 2026.

2. Biotech Healthcare announces the successful launch of Optiflex XTENSE Comfort Plus (Full Visual Range EDOF IOL) at ESCRS 2025, Copenhagen. News release. Biotech Healthcare. Published October 6, 2025. Accessed October 14, 2025. https://biotechhealthcare.com/news-rooms/optiflex-xtense-comfort-plus-successfully-launched-at-escrs-2025-copenhagen/

3. Optiflex XTENSE Comfort Plus full visual range of EDOF IOL features. Biotech Healthcare. Accessed October 14, 2025. https://biotechhealthcare.com/products/optiflex-xtense-comfort-plus/

4. About Us. Biotech Healthcare. Accessed October 14, 2025. https://biotechhealthcare.com/about-us/