BVI, an ophthalmic device company, has received 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).
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intraocular lens
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:
- Strict requirements with the intention to prove the safety of medical devices for both users and patients;
- Increased transparency of clinical evaluation, post market surveillance, and clinical investigation that needs to be up to date, clear, convincing, and publicly available;
- Greater emphasis on detailed requirements for technical documentation;
- Increased control and monitoring by national competent authorities and the EC;
- Reclassification of devices, wider scope of devices; and
- New Unique Device Identification system with enhanced traceability and post-market surveillance.
Shervin Korangy, BVI president and CEO, said: “Achieving and maintaining MDR certification is a major effort that requires a tremendous amount of investment, capabilities, and hard work. 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 directives – so being at the forefront of this is a testament to our team’s expertise and dedication to our customers.”
