The next meeting of the MDCG is schedule for 20 June 2019.
Some guidance are up for endorsement:
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.
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.