The Medical Device Coordination Group (MDCG) published a (non-exhaustive) list of guidance documents in development: HERE

Among the 2023 deliverables include:

• • Guidance on Post-Market Surveillance requirements (Q2 2023)
  • Harmonized reporting forms for incidents (Q2 2023)
  • Update to MDCG 2021-27 Q&A on Importers & Distributors (Q2 2023)
  • Update to MDCG 2019-7 of PRRC Guidance (Q2 2023)
  • Guidance on medical device software (MDSW)-hardware combination systems (2023)
  • Guidance on Master UDI-DI (Q3 2023)
  • Q&A on IVD Performance Studies (Q3 2023)
  • FAQ on EMDN (2023)
  • Mapping of EMDN-GMDN (“outcome of this exercise is highly dependent on level of cooperation ensured by GMDN”)

The overview also notes the IVDR common specifications are under development for the following products:

• • Hepatitis E
  • Plasmodium and Toxoplasma
  • Arbovirus (Zika, West Nile, Chikungunya, Dengue)

As new common specifications are released, they will be added to our Resource Page: List of EU MDR/IVDR Harmonized Standards & Common Specifications

Please review the MDCG’s document for the full list of pending items. As always, Casus will publish an overview of key takeaways as each MDCG document is updated or newly released.