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,…
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…
Future UK recognition of devices from EU, US, Canada, and Australia
The Medicines and Health Regulatory Authority (MHRA) has announced on May 21, 2024, the intention to accept medical devices that already conform to regulations in…
Regulatory updates: January 2024
With the start of 2024, the EU, UK, and Swiss competent authorities provided new regulatory documents. In this post, we will provide an overview of…
CE recognition period extended: UK law officially published
On 14 June 2023, the UK Government published The Medical Devices (Amendment) (Great Britain) Regulations 2023. As mentioned in our previous post, Statutory Instrument 2023…