BVI Announces Certification for its Intraocular Lens Portfolio under the European Medical Device Regulation
WALTHAM, Mass., Sept. 15, 2022 (GLOBE NEWSWIRE) -- BVI, a diversified global ophthalmic device company, today announced certification for its intraocular lens (IOL) portfolio under the European Medical Device Regulation (MDR, (EU) 2017/745) from its Notified Body, the British Standards Institution (BSI)¹. The new regulatory criteria came into effect in May 2021, replacing the prior Medical Device Directive (MDD).
The MDR, representing the most significant change to European regulatory framework in decades, ensures a consistently high level of health and safety for medical devices. The new provisions focus on:
“Achieving and maintaining MR certification is a major effort that requires a tremendous amount of investment, capabilities, and hard work,” said Shervin Korangy, BVI President and CEO. “This important milestone ensures continued supply of our innovative and clinically differentiated IOLS to our surgeons and patients worldwide.”
BVI Senior Vice President, Business Operations and Quality Assurance, Devang Shah, Ph.D. added, “We are proud to have obtained this certification, in partnership with our Notified Body BSI, which confirms BVI’s commitment to quality and compliance to the highest of regulatory standards. A recent MedTech report highlighted that Notified Bodies have yet to issue MDR certificates for more than 85% of the products certified under the prior directives² – so being at the forefront of this is a testament to our team’s expertise and dedication to our customers.”
BVI® is a diversified global ophthalmic device company with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients. With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe. Our organization supports surgical teams in more than 115 countries worldwide, either directly or through our network of trusted distributors. Our trusted brands include: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs).