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EU – New items from the MDCG meeting agendas

So new draft agendas were published for some of the next MDCG meetings. Here are some topics that caught my attention (besides the important general ones, such as updates on the Rolling Plan and NB designation):

  • Joint Implementation Plan – endorsement
  • Guidance on significant changes [Art. 120.3 (EU) 2017/745] with regard to devices covered by certificates according to 90/385/EEC or 93/42/EEC – for endorsement
  • Class I transitional provisions in Article 120 (3)(4) – for endorsement
  • Addendum to guidance document MDCG-2019-3 on interpretation of application of Article 54(2)b (EU) 2017/745 – for endorsement
  • Guidance on clinical evaluation and performance evaluation of medical device software – for endorsement
  • Guidance on clinical evidence requirements needed for medical devices previously certified under Directives 93/42/EEC and 90/385/EEC (legacy medical devices) – for information
  • Guidance on Equivalence – state of play
  • Information Note on Transparency obligations – state of play
  • EU Participation in the IMDRF (International Medical Devices Regulators Forum)
  • Developments with regard to guidance on MDSAP (Medical Device Single Audit Programme)

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