We urgently require member companies’ feedback on the MHRA’s proposal to charge annual fees per GMDN code. If implemented, this would significantly increase costs for the IVD industry – to the point were some products are likely to be commercially unviable.
For example, one company currently pays £210 for 100 GMDN codes per year. This is set to change to £210 per GMDN code per year, causing their costs to balloon to £21,000 annually.
So far we have received significant responses from member companies who will be impacted. We are grateful for the time and care that members have put in, which allows us to robustly respond to these proposals.
We will respond to the consultation directly and have had a number of conversations with the MHRA about potential impacts. A FOI request reveals that the MHRA’s financial modelling is not broken down to the level of IVDs. We will continue to keep members informed of any developments.
Please can you send all feedback to regulatory@bivda.org.uk by 5pm on Friday 11th October.
