Stay up to date with BSI’s updates for medical devices and IVDs. Gain access to new resources through our monthly newsletter. Sign up for our newsletter today to receive BSI regulatory updates, here: https://bit.ly/4csT07Q #BSI #MedicalDevices #IVDR #MDR #RegulatoryServicesNewsletter
BSI Medical Devices
Medical Equipment Manufacturing
London, Greater London 71,551 followers
Your source of the latest news and developments in the medical device industry
About us
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.
- Website
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http://bit.ly/bsimeddev
External link for BSI Medical Devices
- Industry
- Medical Equipment Manufacturing
- Company size
- 5,001-10,000 employees
- Headquarters
- London, Greater London
- Founded
- 1901
Updates
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On 9 July, the EU Commission published Regulation (EU) 2024/1860 on the OJEU. Check out the new IVDR transition timeline and visit our dedicated IVDR webpage: https://bit.ly/3Y4dDTH Stay tuned on BSI In Vitro Diagnostics Regulatory Services for upcoming guidance. #BSI #MedicalDevices #IVDR #AmendingRegulation #Timeline
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Join Us in Celebrating a Major Milestone: 1,500 MDR Certificates Issued by BSI! Visit our website to learn more about our comprehensive certification services and how we can support your certification journey: https://bit.ly/4cTCP3q #BSI #MedicalDevices #BSIMilestone #1500MDRCertificates
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On 9 July, Regulation (EU) 2024/1860 was published on the OJEU with immediate effect. Check out our EUDAMED guidance to navigate the new timeline, relevant changes, and next steps towards the now mandatory use of gradually rolled-out EUDAMED modules. Discover BSI’s commitment to reshaping its operating processes and procedures to remain compliant and to set the basis to efficiently interact with EUDAMED. Visit our Medical device webpage: https://bit.ly/3WhqAIo #BSI #MedicalDevices #IVDs #EUDAMED #AmendingRegulation
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BSI welcomes the new Amending Regulation, which ensures market access to safe in vitro diagnostic medical devices while providing additional time for manufacturers and Notified Bodies to transition their devices to the IVDR. Take a look at our e-news for insights on Regulation (EU) 2024/1860: https://bit.ly/3WiDTIo #BSI #MedicalDevices #IVDR #AmendingRegulation
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Check out our IVDR Transition Guidance to discover key elements of Regulation (EU) 2024/1860.
Check out our IVDR Transition Guidance to discover key elements of Regulation (EU) 2024/1860 and to easily navigate the possible implications for your business and understand the conditions you are required to meet to continue placing IVDs on the EU market. Stay tuned on our IVDR dedicated webpage for upcoming guidance: https://bit.ly/3zLhomy #BSI #MedicalDevices #IVDR #AmendingRegulation
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Check out our IVDR transition FAQ on Regulation (EU) 2024/1860. Stay tuned on BSI In Vitro Diagnostics Regulatory Services for upcoming guidance!
Check out our IVDR transition FAQ on Regulation (EU) 2024/1860. Stay tuned on our dedicated IVDR webpage for upcoming guidance: https://bit.ly/3xUn9Ow #BSI #MedicalDevices #IVDR #AmendingRegulation
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Check out the new IVDR transition timeline and follow BSI In Vitro Diagnostics Regulatory Services for upcoming updates and guidance!
On 9 July, the EU Commission published Regulation (EU) 2024/1860 on the OJEU. Check out the new IVDR transition timeline and visit our dedicated IVDR webpage: https://bit.ly/3Y4dDTH #BSI #MedicalDevices #IVDR #AmendingRegulation #Timeline
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The wait is over. The completely revised BS EN ISO 17665:2024 standard for moist heat sterilization is here, combining all your needs into one document. Benefits you can’t miss: Compliance: meets MDR requirements and UK Health Technical Memoranda Risk mitigation: identify and address potential issues proactively Confidence: increase patient and staff trust in sterilized equipment Ready to upgrade your moist heat sterilization practices? Discover: https://bit.ly/3ycqOqx Shop today: https://bit.ly/44wn27o #BSI#MedicalDevices#BSIStandards #ISO17665 #MedicalDeviceSterilization #MoistHeatSterilization
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Today the EU Commission published on the OJEU Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices. Only IVDD legacy devices may benefit from the extended transition period if: • The device continues to comply with IVDD requirements • There are no significant changes in design or intended purpose or the device • The device does not present an unacceptable risk to the health and safety of patient • The manufacturer has implemented an IVDR compliant QMS no later than 25 May 2025 • The manufacturer has lodged a formal application with a NB by May 2025 for IVDD certified and class D self-declared devices, by May 2026 for Class C self-declared IVDs and by May 2027 for class B and A-Sterile self-declared IVDs • The manufacturer has signed a written agreement with a NB by September 2025 for IVDD certified and class D self-declared devices, by September 2026 for Class C self-declared IVDs and by September 2027 for class B and A-Sterile self-declared IVDs If the above requirements are fulfilled, the transition period is extended to: • 31 December 2027 for IVDD certified devices and Class D self-declared devices • 31 December 2028 for Class C self-declared devices • 31 December 2029 for Class B and A-Sterile self-declared devices To access the Amending Regulation text click: https://bit.ly/4eSflgP Visit BSI In Vitro Diagnostics Regulatory Services for upcoming updates and stay tuned for additional guidance! #BSI #MedicalDevices #IVDR #EUDAMED #AmendingRegulation
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