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Evaluation ViewAttendees 26

Devices (includes Medical Devices and In Vitro Diagnostics)

Will EU IVDR implementation benefit from MDCG 2022-14 and if so, HOW?

Thursday, October 5, 2023
2:00 PM – 3:00 PM EDT
Location/Room: 511E
Expert Level
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 13 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 September 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:

  • Participants will understand how changes of the transition provisions to IVDR have effect on the availability of the IVDs in Europe addressing the NB Capacity as described in MDCG 2022-14
  • Participants will understand the importance of a regulatory strategy regarding legacy products under the IVDR in Europe and how to deal with Art 110 and MDCG 2022-14 (as input).
  • Participants will understand from stakeholders to what extend the IVDR has influenced geography) and timing of new, innovative product launches taken into account the availability of the Notified body.