BSI issues its first certificate to the In Vitro Diagnostic Devices Regulation
18 December 2020
BD earns certificate under Annex IX Chapter I & III
BSI today announces that it has certified its first group of products to the In Vitro Diagnostic Devices Regulation (IVDR) EU 2017/746 via its Netherlands Notified Body (2797).
The Annex IX Chapter I & III certificate covers two Class C Generic device groups for Monoclonal Antibodies/Flow Cytometry. Prior to the new, more stringent, legislation coming into force, these were classified as self-declared devices and did not need to be reviewed by a notified body under the IVD Directive.
The certificate has been granted to BD (Becton, Dickinson and Company), a leading global medical technology company based in Franklin Lakes, NJ.
Manuela Gazzard, Group Director for Regulatory Services at BSI, said: “We are delighted to be issuing our first conformity certificate under the new IVDR to BD Biosciences. This is a testament to their commitment to ensuring innovation remains at the forefront of their product development. These high-risk products will support patient safety at a critical time and are a sign of the resilience of our industry.”
Erica Conway, Global Head of IVD Medical Devices at BSI, added: “Approving our first IVDR devices is an honour. Achieving our IVDR designations and now delivering a conformity assessment under the new Regulation is evidence of the hard work, dedication, skills and expertise of our people. The Regulation is a significant challenge to the in vitro diagnostic device industry, and it brings greater regulatory requirements on all Economic Operators in the system from manufacturers and notified bodies to importers and distributors. We are proud to have expanded our expertise internally and met the stringent requirements. We continue to work towards certifying more devices under the IVDR, including those that are currently self-certified, to what are becoming tighter timelines as we approach the May 2022 deadline.
Puneet Sarin, Worldwide President for BD Biosciences shares, “Being the first medical technology company to receive the new IVDR Annex IX Chapter I & III, Class C certificate from BSI reinforces our commitment to quality and regulatory compliance. The new IVDR also reflects the European Union’s steadfast commitment to quality for all in vitro diagnostic devices and ensuring all such products meet the highest quality and regulatory compliance. I would like to thank both BSI for the timely and high-quality review of this first group of devices and the BD Biosciences cross-functional IVDR project team members who were instrumental in reaching this significant milestone.”
Ken Gelhaus, VP/GM Clinical Solutions for BD Biosciences adds, “BD Biosciences is pleased to be among the first medical technology companies to receive IVDR certification from BSI. Along with BSI, we recognize the utmost importance of the new requirements in IVDR and its positive impact on both customers and patients. This important event reflects our commitment, and we look forward to bringing additional products to IVDR compliance by May 2022.”
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