At a recent meeting between MHRA and Trade Associations, it was raised that MHRA are utilising the registrations system as a method of monitoring compliance of products. This includes rejecting applications for registration where there are errors or omissions rather than giving the applicant an opportunity to correct those mistakes. This results in the products needing to be removed from the market, disrupting supply.
MHRA have released a list of the most common errors that they have identified within registration applications for devices.
The full list can be found here , but includes common errors in letters of designation, declarations of conformity, validation of the correct UK approved body or EU notified body, and GMDN codes.
We recommend you review this document if you submit registration requests to the MHRA, to ensure these field are inputted correctly.
As well as this, MHRA are looking at their current process for reviewing registration requests, particularly those where the classification or compliance of the product is in question. Some suppliers have received requests to remove products from the market due to MHRA disagreeing with the listed classification. In some cases, similar products are not receiving the same level of scrutiny, so the process does not seem to be equal across all products.
BIVDA hopes to have an update from MHRA at the next meeting regarding this, but if you have been affected by MHRA requests such as these in relation to your MHRA registration, please let Ashleigh know.