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…