There’s still time to register! Join us for our upcoming “Understanding and meeting the EU IVDR requirements for In Vitro Diagnostics (IVD) Kits” webinar. Our speakers @Alex Laan, Head of Notified Body – IVD and @Sara Fabi, Regulatory Lead, Notified Body – IVD will shed some light on definitions of IVD kits, accessories, components, and procedure packs. This webinar is useful for IVD manufacturers, distributors, and importers. Participants will gain an understanding of qualification and classification as well as regulatory requirements of IVD kits as we discuss product configurations and potential certification scenarios. To register choose one of the time slots below: https://bit.ly/3WEFHMi Tuesday 10 September 2024 09:00 – 10:00 BST Tuesday 10 September 2024 16:00 – 17:00 BST #BSI #IVDR #IVDKits #RegulatoryCompliance
BSI In Vitro Diagnostics Regulatory Services
Medical Equipment Manufacturing
Ensuring patient safety – Supporting timely access to global in vitro medical device technology
About us
As a manufacturer of In Vitro Diagnostic (IVD) medical devices, you must ensure that you meet the relevant regulatory requirements before placing your product onto the market. It is critical to work with a trusted EU Notified Body or UK Approved Body that understands the industry and has the experience to review and confirm your product’s readiness for market. BSI Group The Netherlands B.V. (2797) is a leading full scope Notified Body; we review medical devices to ensure that they conform to the requirements of the European Regulations. BSI Assurance Ltd (0086) is a full scope UK Approved Body able to provide conformity assessments under the UKCA scheme. Our mission is to ensure patient safety whilst supporting timely market access to medical technology in a sustainable manner. We strive to set the global standard through conducting impartial, responsive, robust and thorough conformity assessments, evaluations and certifications that are recognized and trusted worldwide. Find out how we can support your product readiness to market.
- Website
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https://www.bsigroup.com/en-GB/capabilities/medical-devices/ivdr/
External link for BSI In Vitro Diagnostics Regulatory Services
- Industry
- Medical Equipment Manufacturing
- Company size
- 1,001-5,000 employees
- Headquarters
- London
- Specialties
- In Vitro Diagnostics, Medical Devices, Market access, CE marking, European Regulations, In Vitro Diagnostics Regulation (IVDR), Full Scope Notified Body, Regulatory Compliance, Conformity Assessment, Medical Devices Product certification, Quality Management System Cerification, Companion Diagnostics, IVDR classification, UK Approved Body, and Regulatory Affairs
Updates
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Check out our IVDR transition FAQ on Regulation (EU) 2024/1860. Stay tuned on our dedicated IVDR webpage for upcoming guidance: https://bit.ly/46Qiudy #BSI #MedicalDevices #IVDR #AmendingRegulation
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Register now for the ‘Rollout of EU Reference Laboratories for IVDR Class D devices’ webinar. Hear our subject matter experts Alex Laan, Head of Notified Body – IVD and Sara Fabi, Regulatory Lead – IVD, as they discuss the newly enrolled EURL regulation. Participants will gain a better understanding on the rollout of EURLs and will be better prepared for the engagement between BSI and the EURLs. Register now for one of the sessions below on Thursday 26 September 2024: https://bit.ly/46UZudE Thursday 26 September 2024 09:00 – 10:00 BST & 16.00 - 17.00 BST #IVD #IVDR #RegulatoryCompliance #EURLs
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Are you a Companion Diagnostic device manufacturer selling into Europe? Watch our dedicated webinar to help you navigate your device conformity assessment with Notified Bodies and EMA under the IVDR, with confidence. Watch on demand: https://bit.ly/4cyCun4 #BSI #MedicalDevices #IVDR #CompanionDiagnostics #CDx
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BSI remains committed to enhancing transparency and predictability of IVDR applications, and certification processes for manufacturers to support their IVDR transition plans. In this poster we present a summary of the certificates issued by BSI Group The Netherlands B.V. (2797) up to April 1st 2024, based on first time certificates issued. Download our poster to gain a better understanding of the types of devices that have already transitioned to the IVDR and of the diversity across different IVDR certificates. Download now: https://bit.ly/4bAogAN #BSI #MedicalDevices #IVDR #NotifedBody
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Discover BSI Meet the Experts: In-Person Education Networking Events across Europe. Save the date for BSI Meet the Experts (IVDR) on 26-27 November 2024 in Amsterdam. See our update below, to find out more. #BSI #IVD #IVDR
Discover BSI Meet the Experts: In-Person Educational Networking Events in Europe We’re committed to providing access to education and training so that medical device professionals have vital knowledge of MDR; IVDR; UKCA; QMS; AI topics and greater clarity and confidence on their certification journey. That’s why we’ve curated an annual program of events in major cities across Europe offering unrivalled access to the BSI Medical Devices team of experts. And an agenda tailored for professionals navigating the complexities of medical device regulation that will demystify the process of working with a Notified Body and Approved Body. In 2024 we’ve already hosted two events in the UK and France but there is still time to join us at upcoming events in the Netherlands, Italy, and Germany. Click here to find out more: https://bit.ly/4dupFut #BSI #MedicalDevices #BSIMeetTHeExperts2024 #MedicalDevices #EUregulation #PartnersInProgress
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Listen back to our webinar ‘Pathways to IVDR compliance’. Presented by Alex Laan, Head of IVD Notified Body and Liz Harrison, Global Head of IVD at BSI. The webinar provided insightful insights into the key IVDR changes and lesson learnt and common pitfalls related to the Technical Documentation and Performance Evaluation requirements under the IVDR. Access the slides and recording here: https://bit.ly/3YUKDhF #BSI #MedicalDevices #IVDR #Webinar
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The Regulation on In Vitro Diagnostic medical devices (EU) 2017/746 introduced updates and expanded definitions that reflect changes in technology, progress in diagnostics, and improvements in regulatory oversights. Join us for our upcoming “Understanding and meeting the EU IVDR requirements for In Vitro Diagnostics (IVD) Kits” webinar. Our speakers Alex Laan, Head of Notified Body – IVD and Sara Fabi, Regulatory Lead, Notified Body – IVD will shed some light on definitions of IVD kits, accessories, components, and procedure packs. To register choose one of the time slots below: https://bit.ly/3WEFHMi Tuesday 10 September 2024 09:00 – 10:00 BST Tuesday 10 September 2024 16:00 – 17:00 BST #BSI #IVDR #IVDKits #RegulatoryCompliance
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Do you know the key requirements for CDx product certification under the EU IVDR? Watch our webinar ‘IVDR Companion Diagnostics Update’ webinar with BSI’s CDx experts to gain better knowledge, hints, and tips on how to navigate CDx conformity assessment with Notified Bodies and EMA, under the IVDR. Watch now: https://bit.ly/4cyCun4 #BSI #MedicalDevices #IVDR #CompanionDiagnostics #CDx
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Listen back to our ‘Maintaining Compliance: IVDR post-certification activities’ webinar, presented by Liz Harrison, Global Head of IVD and James Kerr, IVD Technical Specialist & Scheme Manager, BSI. The webinar presents a brief overview of IVDR post-certification activities before providing an in-depth look at what to expect from IVDR Technical Documentation surveillance reviews as well as explaining the requirements for PMPF. Access the recording and slides, here: https://bit.ly/3A27MEh #BSI #MedicalDevices #IVDR #PostCertification #RegulatoryCompliance
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