GlobeNewswire by notified

BVI Announces Certification for its Intraocular Lens Portfolio under the European Medical Device Regulation

Share

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:

  • 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.”

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.”

About BVI

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).

  1. BSI Client Directory Profile: https://www.bsigroup.com/en-GB/validate-bsi-issued-certificates/client-directory-profile/PHYSIO-0047610705-000
  2. https://www.medtechdive.com/news/legacy-devices-lack-mdr-certificates-medtech-europe/627439/

Contacts
BVI
Andrew Dawson
Corporate Communications
adawson@bvimedical.com

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://notified.com

GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire by notified

Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire by notified

Automox Expands Functionality and Reach with Remote Control and New Global Partnership4.10.2022 15:00:00 CEST | Press release

Product and distribution momentum set to fuel international growth Boulder, Colo, Oct. 04, 2022 (GLOBE NEWSWIRE) -- Automox®, the cloud-native IT operations provider, today announced general availability of its remote control feature, offering global IT teams advanced troubleshooting capabilities from a single cloud-native console. Remote control is a powerful tool for IT teams everywhere. IT administrators often face a mountain of device-related issues daily, ranging from email account errors, password resets, and devices that won’t update, to processes that drain device resources. Without the ability to perform an in-depth investigation directly on the device, providing a fix generally requires significant time from IT teams and multiple tools. With remote control, IT admins can gain immediate access to end-user devices to troubleshoot issues directly. The functionality was developed in-house by Automox’s product team to help IT teams quickly address a wide array of common endpoint i

Huhtamaki launches innovative, recyclable ice cream packaging solution in the US, made with 95% renewable biobased material4.10.2022 15:00:00 CEST | Press release

HUHTAMÄKI OYJ PRESS RELEASE 04.10.2022 AT 16.00 EEST Huhtamaki launchesinnovative, recyclableice cream packaging solution in the US, made with 95% renewable biobased material Paper-based technology allows packaging to enter the North American paper recycling system easily.ConnectedPackaging QR code provides consumers with more information on sustainability. Huhtamaki, a key global provider of sustainable packaging solutions, today launches ICON® packaging, a breakthrough paper technology, initially for use for ice cream containers and lids, which enables recycling in communities with paper product recycling programs across the United States. This is a significant breakthrough in delivering a sustainable solution for consumers which combines Huhtamaki’s proprietary water-based barrier coating with SFI-certified paperboard and results in the entire package being made with 95% renewable biobased material. This enables the ice cream containers and lids to be recycled along with other paper

Tilray Medical Relaunches Cannabis Oral Solution Across Ireland4.10.2022 13:00:00 CEST | Press release

Tilray’s Medical Cannabis Product Now Available and Reimbursed Under Ireland’s Medical Cannabis Access Program LEAMINGTON, Ontario and CANTANHEDE, Portugal, Oct. 04, 2022 (GLOBE NEWSWIRE) -- Tilray Brands, Inc. ("Tilray" or the "Company") (Nasdaq: TLRY; TSX: TLRY), a leading global cannabis company inspiring and empowering the worldwide community to live their very best life, today announced that it has successfully relaunched its EU GMP-produced medical cannabis oral solution in Ireland under the country’s Medical Cannabis Access Program (MCAP). Tilray’s approved product has also recently received reimbursement approval, which gives patients cost reimbursement and ensures more eligible patients can access quality medical cannabis under Ireland’s MCAP. Denise Faltischek, Tilray Brands’ Chief Strategy Officer and Head of International Business, said, “We are extremely proud to relaunch in Ireland with an expanded footprint. The MCAP reimbursement approval is a tremendous step in providi

Moore Nanotechnology Systems Opens Global Training and Process Development Center in Charlotte, North Carolina4.10.2022 13:00:00 CEST | Press release

SWANZEY, N.H., Oct. 04, 2022 (GLOBE NEWSWIRE) -- Moore Nanotechnology Systems (“Nanotech”), a leading global supplier of ultra-precision machining systems, announces the grand opening of their Global Training and Process Development Center in Charlotte, North Carolina. Mark Boomgarden, President and CEO of Nanotech shared, “Nanotech is very excited to announce the grand opening of our Global Training and Process Development Center in Charlotte, North Carolina. Although the initial focus of this facility is to provide customer-specific training and industry-leading process development, it also provides Nanotech incremental production capacity to meet the demands of a rapidly growing market.” Nanotech purchased and recently completed the upfit of a 50,000 ft2 building located in the Northpark Corporate Park - Charlotte, NC. Nanotech’s core technology and employee base is in Swanzey, New Hampshire, and this foundation is fundamental to the products and services in which they provide. But

FRO - Changes to the Board composition4.10.2022 08:06:57 CEST | Press release

Frontline Ltd. (“Frontline” or “the Company”) announces the appointment of Mr. Marios Demetriades as a Director of the Company. Marios Demetriades is an experienced Financial Services professional with significant experience as a Non-Executive Director in various listed and private companies in the Banking, Infrastructure and Shipping industries. He previously served as the Minister of Transport, Communications and Works for the Republic of Cyprus from 2014 to 2018 and held various positions in the Accounting, Investment and Banking sectors. He is a qualified Chartered Accountant and Chartered Financial Analyst holder and a member of the CFA Institute, the Institute of Chartered Accountants in England and Wales and the Institute of Certified Public Accountants of Cyprus (ICPAC). Mr. Demetriades is a Cypriot citizen and resides in Cyprus. October 4, 2022 The Board of Directors Frontline Ltd. Hamilton, Bermuda Questions should be directed to: Lars H. Barstad, Chief Executive Officer, Fro