When quality issues arise in the lifecycle of a medicinal product, the consequences extend far beyond the pharmacy shelf. The MHRA’s latest 2026 guidance on defective medicinal products offers a comprehensive roadmap for managing these events with rigour, transparency, and patient safety at the centre.
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.
Are your quality and audit team ready for the digital shift? Do they have the right mindset? The tools are there is it time to assess which ones are right for your organisation.
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.
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.
Pharmacy updates are coming into force on 7th January 2026 with regards to pharmacy supervision legislation and covering authorisations by a pharmacist who is absent or treated as absent – handing out checked and bagged prescriptions.
