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ViewAttendees 15

IVD

Domain: Regulatory Frameworks & Strategy

Knowledge Area: Process & Procedures

MDCG22-14 Panel: Will IVDR Implementation Benefit From MDCG 2022-14 and if so, How ?

Friday, May 12, 2023
15:30 – 16:30 CEST
Location: Pearl 2

Supported By
Description: MDCG position paper “Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDs - (MDCG 2022-14), which was published in August 2022 mainly focuses on implementation of MDR. But in its introduction is stated that, though the challenges are more pressing for the MDR, most of the actions listed could apply for IVDR as well.
This session will analyse the state of play 8 months after the publication of MDCG 2022-14 for IVDR. MDCG 2022-14 aims at enhancing the implementation of MDR (and IVDR) by proposing a list of 19 different actions.
Which proposed actions have been ' transferred' to IVDR, how did these proposed actions work out, which of these have been successful and what are the results, e.g. in terms of more IVDs transferred from IVDD to IVDR, more Notified Body capacity, enhanced preparedness of manufacturers?
In case MDCG 2022-14 will have been amended or followed up by other actions by the regulators between September 2022 and May 2023, these amendments or follow-up will be covered as well.
This session will bring together representatives of authorities, notified bodies and manufacturers, who will jointly evaluate the follow-up and the progress.

Learning Objectives:

  • Be brought up to date on the latest state of play of the IVDR implementation
  • Will understand which actions of MDCG 2022-14 have been ' transferred' to IVDR, which of those have been successful and why
  • Will have a clear picture of actions to be taken by the various stakholders (manufacturers, notified bodie, authorities) in the near future to enhance IVDR implementation