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

Marcelo

Inactive Registered Visitor
#1
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...

You may comment and discuss in this discussion thread.
 
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Gish

Registered
#2
This appears to be a circular reference. I followed the link to your external website and clicked on the hyperlink which took me to a category listing of similar topics. I was not able to find a link to the actual 20 June meeting information that is described. Can you please provide a link to the actual topic mentioned here?
 
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