The MHRA, the UK Medicines and Healthcare products Regulatory Agency, released a new standardised format for the periodic safety update report (PSUR). Dated June 2025,…
MHRA guidance on new UK PMS Regulations
The Medical Devices Post-market Surveillance Requirements Regulations 2024 amends the UK Medical Devices Regulations (MDR) 2002 and includes a new section on post-market surveillance (PMS)…
UK government response to consultation on medical devices regulations: key takeaways for manufacturers
On 26/02/2025, the UK government published its response to the public consultation on proposed amendments to the Medical Devices Regulations 2002 concerning four specific pieces…
New MHRA guidance on classification of DMHTs as software medical devices
On 3 February 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) released a new guidance document to help manufacturers navigate the regulatory landscape…
2025 deadlines for medtech in the EU, UK, and Switzerland
2025 brings crucial regulatory deadlines for the medtech sector across the EU, UK, and Switzerland. Some of the key dates and requirements that a manufacturer…
Future UK medical devices regulation: Roadmap
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released Version 2.0 of its Medical Devices Regulatory Reform Roadmap, providing a detailed timeline for…