Thu, Jan 16 | Webex

In Vitro Diagnostic (IVD) New IVDR CE Marking Workshop

The Invitro Diagnostic Regulations are in transition and companies need to understand and prepare for these significant changes.
Registration is Closed

Time & Location

Jan 16, 2020, 2:00 PM GMT
Webex

About the Event

This one day workshop was run by SEHTA and Psephos Biomedica on 16th January 2020.

The Invitro Diagnostic Regulations are in transition and companies need to understand and prepare for these significant changes.  The workshop aimed to gain an understanding of:

  • The new IVD regulations (EU 2017/746), Device Classification and Key Time Lines
  • Significant differences between the current directive (98/79/EC) and the new IVD Regulations
  • The role and status of Notified Bodies
  • Outline of the Technical Documentation including Labelling and EUDAMED
  • Outline of the Quality System requirements
  • Outline of the Performance requirements/Clinical evidence
  • Outline of Post Market Surveillance requirements
  • Interact with fellow practitioners and presenter during the Q&A

The European Union’s Regulation on IVD medical devices 2017/746 (IVDR) came into force on 25 May 2017 and is currently in implementation. It will replace Directive 98/79/EC on IVD medical devices (IVDD) and there are only 2 ½ years left until the end of the transition.

Manufacturers of new IVD devices and devices currently approved under the current Directive will have to  comply  to  IVDR  from  May  2022  onwards.  This  means  they  must  comply  with  the  new  conformity assessment procedure for their device and quality system in order to CE-mark their devices and place them  on  the  EU  market.  For  products  currently  certified  by  a  notified  body - provided  certain  MDR requirements are met - the transition period may be extended until 26 May 2024.

New  or  stricter  requirements  of  the  IVDR  will  be  challenging  and  have  a  significant  impact  on manufacturers  and  all  other stakeholders.  Changes  affect  areas  such  as  classification  of IVD  devices, conformity  assessment  procedures,  performance/clinical  evidence,  post  market  surveillance,  labelling and registration.

The majority of devices will be reclassified and require Notified Body conformity assessment. For existing IVD manufacturers  to meet the May 2022 deadline  they will need to understand what is  required and have a plan to address their current gap. For new manufacturers and devices understanding the new timelines, resourcing and expertise requirements will be crucial to success.

This seminar provided insights into the key regulatory changes of the IVDR, to help prepare  organisations and their devices for IVDR compliance.

Registration is Closed

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