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Please see below request for feedback regarding implementation issues with the EU MIR 7.3.1.

I would need feedback by midday Monday 30th June please, to regulatory@bivda.org.uk


Dear All,

The European Commission has reached out to us with a request to provide feedback on the state of play of IT implementation of MIR 7.3.1 PDF file.

The European Commission has received questions from software companies which work on MIR 7.3.1. PDF and requested clarifications on some aspects of the business rules of the MIR Helptext. Therefore ,they thought that Manufacturers which adapt their databases may have the same or similar concerns. They asked us to check with our members if you have difficulties to understand the functioning of the MIR PDF in relation to the MIR Helptext. Perhaps, it is possible to check and confirm with the software vendors that are supporting your companies if they have raised or can confirm this issue?

In case you have any feedback, please let me know by 30 June (next Monday) EOB.

The European Commission wants to discuss it in MDCG PMSV meeting that is planned on 2nd July and see if they can provide an appropriate support to speed up the IT development and internal implementation for manufacturers within the 6-month transition period.

Ben Kemp