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ViewAttendees 27

Medical Devices

Domain: Product Development & Registration

Knowledge Area: Regulatory Guidance

MDCG 2022-14: Game-Changer or 'Shopping List' for MDR Implementation?

Thursday, May 11, 2023
09:00 – 10:00 CEST
Location: Pearl 2

Supported by 
Description: This session will analyse and evaluate the state of play of the MDR implementation 8 months after the publication of MDCG position paper “Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDs -Transition to the MDR and IVDR (MDCG 2022-14) in August 2022.
MDCG 2022-14 aims at enhancing the implementation of MDR and IVDR by proposing a list of 19 different actions. Although IVDR is mentioned in the title in the introduction, the position paper focuses on MDR implementation, for which issues were considered more urgent.
The session will analyse how these 19 proposed actions work out, which proposed actions have been successful and what are the results, e.g. in terms of more devices transferred from MDD/AIMDD to MDR, 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 follow-up, progress and in what areas there is still work to be done.
As MDCG 2022-14 contains 19 proposed actions, and some of these could have potentially a big impact, it is recommended to allocate a 90 min slot for this session

Learning Objectives:

  • Upon completion, participant will be able to understand the latest state of play of the MDR implementation
  • Upon completion, participant will be able to understand which actions of MDCG 2022-14 still will need additional work
  • Upon completion, participant will be able to understand which actions of MDCG 2022-14 have been successful and why