Diese Präsentation wurde erfolgreich gemeldet.
Wir verwenden Ihre LinkedIn Profilangaben und Informationen zu Ihren Aktivitäten, um Anzeigen zu personalisieren und Ihnen relevantere Inhalte anzuzeigen. Sie können Ihre Anzeigeneinstellungen jederzeit ändern.

Bsi ivdr-toolkit-2020 ivdr transition toolkit

106 Aufrufe

Veröffentlicht am

The transition to the IVDR requires IVD device manufacturers to plan and implement the new requirements, undergo a conformity assessment to CE mark each device, and make any necessary adjustments before May 2022.

Our IVDR Transition toolkit directs you to all the key resources you need to prepare for your transition.

Veröffentlicht in: Bildung
  • Als Erste(r) kommentieren

  • Gehören Sie zu den Ersten, denen das gefällt!

Bsi ivdr-toolkit-2020 ivdr transition toolkit

  1. 1. ass Is/Im/Ir devices 2 ass IIa devices 4 ass IIb Annex VIII rule 12 devices 8 ass IIb implantable – Well-Established Technologies (WET) 10 ass IIb non-implantable non rule 12 devices (non WET) 10 ass IIb implantable devices (excluding WET) 14 ass III non-implantable devices 16 ass III implantable devices 18 ustom-made Class III implantable devices 20 ustom-made devices (excluding custom-made Class III implantable devices) 22 ass I devices (excluding Class Is/Im/Ir devices) 23 S: presented in the conformity assessment flow charts elow is based on our current understanding of the MDR s at the time of publishing this document; subject to change. The tables do not cover assessments under the conformity routes Annex X (Type Examination) and Annex XI Part B (Product Verification) which may require additional tests or examinations of the devices. The tables present a generalization of the requirements based on the classification of devices and some exceptions may apply. The IVDR Date of Application is approaching Are you ready for the May 2022 deadline? The entered into force in May 2017 with a five- year transition period. Manufacturers have the duration of the transition period to update their Technical Documentation to meet the requirements and comply with the Regulation before the Date of Application of the IVDR in May 2022. Inspiring trust for a more resilient world. Your IVDR Transition Toolkit Conformity Assessments from a full scope IVDR Notified Body BSI has two Notified Bodies, one in the UK (0086) and one in the Netherlands (2797), both of which have full scope designations to the IVDR and MDR. Supported by a dedicated IVD team of 19 technical specialists, who have an average of 20 years' experience, BSI is able to provide conformity assessments for CE marking of IVD medical devices whatever the outcome of Brexit. More information is available on our website: Use our resources to support your transition. Inspiring trust for a more resilient world. www.bsigroup.com/ivdr In Vitro Diagnostic Regulation (IVDR) EU 2017/746
  2. 2. It is important that you start your application early Your IVDR Transition Toolkit Copyright©2020,TheBritishStandardsInstitutionBSI/UK/081/MD/0620/en/BLD The transition to the IVDR requires you to plan and implement the new requirements, undergo a conformity assessment for your device, and make any necessary adjustments before May 2022. It is important for you to have an understanding of the IVDR before applying for conformity assessment to CE mark your device and place it onto the EU market. Use this toolkit to access the key resources you need to prepare for your transition. Brochures and guidance documents Whitepapers Webinars Training Talk to BSI today Call: +44 345 080 9000 Visit: bsigroup.com/medical and start your journey For more information on these and our full range of IVDR training courses, visit our website: www.bsigroup.com/ivdr • IVDR FAQs • IVDR Readiness Review • Conformity Assessment Routes Guide • IVDR Training Courses • IVDR Best Practices Guidelines • QMS for IVDs • IVD classification issues • Post-market surveillance • Risk management • Conformity Assessment Routes • IVDR application process • GSPR and the IVDR • QMS requirements under the IVDR • IVD to IVDR transition • Implementation of the IVDR for CE marking • Requirements of the IVDR for CE marking

×