The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a call for evidence to collect feedback from stakeholders on the use of designated standards…
UK Proposal to improve medical devices access in Great Britain
On 22 July 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) announced a proposal to improve access to medical devices for patients in…
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…
UK Regulations on Post-market Surveillance Requirements
On 15 January 2025, the MHRA (Medicines & Healthcare products Regulatory Agency) released a new guidance on PMS requirements for medical devices following the adoption…
MHRA on future UK law on medical devices
On 5 March 2024, the UK MHRA (Medicines and Healthcare Products Regulatory Agency) held the MedTech Regulatory Reform Webinar. This online webinar provided insight into…
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…
UK: Extension of CE recognition & Registration of extended Certificates
The UK government announced that it intends to prolong the acceptance of CE marked medical devices on the Great Britain market! In Spring 2023, a…