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

Marcelo

Inactive Registered Visitor
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.
 

Gish

Gish Consulting LLC
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?
 
Top Bottom