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Informational Next meeting of the Medical Device Coordination Group (MDR/IVDR) – 20 June 2019

Added to Calendar: 19-06-19

Marcelo Antunes

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The next meeting of the MDCG is schedule for 20 June 2019.

Some guidance are up for endorsement:

  • Vigilance: Manufacturer Periodic Safety Report (MPSR) form – for endorsementImplant card guidance
  • Guidance on Summary of safety and clinical performance
  • Person responsible for regulatory compliance, guidance on article 15 MDR / IVDR

These are some of the 15+ itens being discussed.

There’s also a document from the April meeting that was going to be endorsed – MPSRF – Manufacturer Periodic Summary Report form – that I did not see published yet, hope we hear about it soon.

Posted at Marcelo's Medicaldevice.expert website...

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