1 / 6

IVDR Classification - CE marking | Operon Strategist

The New IVDR Classification necessary changes are compared with the previous In Vitro Diagnostics Directives structure.<br>Contact details u2013 <br>Phone no - 9325283428<br>Mail - dm@operonstrategist.com<br>Visit u2013 https://www.operonstrategist.com/ivdr-classification/#utm_source=ppt and pdf submission&utm_medium=ppt and pdf page&utm_campaign=ppt and pdf submission<br>

operon
Download Presentation

IVDR Classification - CE marking | Operon Strategist

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. IVDR Classification –CE marking | Operon Strategist Call / Whatsapp - 9325283428 www.operonstrategist.com

  2. The NewIVDR Classificationnecessary changes are compared with the previous In Vitro Diagnostics Directives structure. Before the arrangement ofIVDDwas a basic and inflexible rundown –based framework that took into account diverse choice by various EU states. TheIVDR(In Vitro Diagnostics Regulation) is the new regulatory reason for placing on the market, making accessible and placing into service in-vitro diagnostics medical devices on the European market. It will supplant the EU’s present order on in-vitro diagnostics medical device (98/79/EC). As a European guideline, it will be compelling in all EU member states. Call / Whatsapp - 9325283428 www.operonstrategist.com

  3. The IVDR Classifications: TheIVDRspecifies four risk-based classes (A –D) for In-vitro diagnostics (IVD) devices. Class A includes IVD devices with the lowest risk and is the only class that does not fall under the Notified Body (NB) supervision. Class D is considered as the highest risked category. TheseEU IVDR classificationsdepend on the Global Harmonization Task Force classifications plan and decided utilizing seven guidelines, which are clarified in more subtleties in theAnnex VIII of the IVDR. Call / Whatsapp - 9325283428 www.operonstrategist.com

  4. The key changes expected in the new IVDR Classifications Reclassification of the devices according to the risks. More correct clinical evidence Product scope expansion More firm or strict documentation Greater inspection of Notified Bodies Call / Whatsapp - 9325283428 www.operonstrategist.com

  5. -We at Operon Strategist help you in the process of making a defined and comprehensive technical file with all product details required forCE marking. -We also provide assistance in your process of making technical file and review it at every step for compliance. -We are theISO 13485consultants we’ll help you to create the documentation required for ISO certification. Call / Whatsapp - 9325283428 www.operonstrategist.com

  6. Thank You. For More Information Contact Us info@operonstrategist.com Call / Whatsapp - 9325283428 www.operonstrategist.com

More Related