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 opens consultation on future UK Medical Devices Regulations
The Medicines and Healthcare products Regulatory Agency (MHRA) just launched a consultation on the future UK regulatory framework for medical devices (UK MDR). The deadline…
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…
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…
United Kingdom: CE marking recognition for medical devices and IVDs
Following the government’s decision to extend the CE mark recognition for a wide range of products, the UK announced that for medical devices, the deadlines…
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…
UK recognises extended CE Certificates
The UK is taking new steps to recognise the extended CE Certificates in light of the recent amendment of the MDR and IVDR transitional periods.…
Medical Devices in the UK: extension for CE marked devices
With Brexit, the legislation of the European Union does not apply in the United Kingdom anymore. Currently, the Medical Device Regulations 2002 (UK MDR 2002)…