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.Tags: IVDR, MDCG, MDR