BVI Announces Certification for its IOL Portfolio Under the European Medical Device Regulation
BVI announced certification for its 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, which BVI says represents the most significant change to European regulatory framework in decades, aims to ensure 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.
“Achieving and maintaining MDR 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.”
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