Medical Devices: Conformity Assessment and the UKCA Mark
This article provides an overview of the recent MHRA update for UKCA conformity assessment for medical devices, with practical insights for regulatory, quality, and executive teams.
Major Changes to MHRA Medical Device Registration Fees
There is a hard stop to the change process, from 1st April the system will be operable, and the products registered at that point will decide the fees payable for 2026/27. So, there are a number of actions manufacturers and UKRPs will need to consider.
Major Changes to MHRA Medical Device Registration Fees
To place medical devices onto the UK market manufacturers must register with the MHRA and register all relevant products, registration must be active when each batch of product is placed on the market. For manufacturers based outside the Uk this is done via the UKRP.
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Medical Device Update
In good news for the UK Health economy, the Government last week published a draft policy to allow medical devices and IVDs that have been approved in certain other countries quicker access to the UK market.
Medical Device Regulatory Updates
Those companies manufacturing and handling medical devices should be aware that there are changes to the UK regulatory environment coming.