The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its responses to the consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices carried out last year....more
On February 5, 2025 Valneva SE (“Valneva”) announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization for Valneva’s chikungunya vaccine, IXCHIQ. ...more
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a suite of guidance specifically designed to help medical device manufacturers understand and prepare for the new post-market surveillance (“PMS”)...more
On 11 December 2024, the MHRA published a revised roadmap for the long-awaited reforms to the UK Medical Device Regulations 2002 (MDR Roadmap). The updated MDR Roadmap provides additional clarity for industry on the intended...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the five technologies selected to participate in the ‘AI Airlock Pilot’ for AI-powered medical devices. The pilot is a regulatory “sandbox” for...more
On 12 December 2024 the statutory instrument to amend the Medicines for Human Use (Clinical Trials) Regulations 2004 (UK CTR) was laid before Parliament. The Medicines and Healthcare products Regulatory Agency (MHRA),...more
Access to first-in-class medicinal products that can save and transform lives is crucial for patients in the UK – and the earlier the access, the more significant the impact. Equally vital, however, is that such products are...more
The MHRA has opened a consultation on proposed future pre-market requirements for medical devices and in vitro diagnostic devices (IVDs) in Great Britain. The consultation expands on proposals considered in the MHRA’s 2021...more
The UK's Medicines and Healthcare products Regulatory Agency ("MHRA") has announced first-of-its-kind legislation to better facilitate the manufacture and delivery to patients of medicines that are manufactured at or near the...more
The MHRA recently published an update on its plans for MedTech regulatory change. The update confirmed that the new framework will be introduced through four statutory instruments to update and replace the UK Medical Devices...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA's) has published a Statement of policy intent: international recognition of medical devices outlining its proposal for the International Recognition Procedure...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
Earlier today, UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization to Vertex Pharmaceuticals and CRISPR Therapeutics for their CRISPR/Cas9 gene therapy, CASGEVY...more
On 12 October 2023, the Medicines and Healthcare products Regulatory Agency (the MHRA) announced that the healthcare and life sciences sector will benefit from a new streamlined notification scheme for lowest-risk clinical...more
The Medicines and Healthcare products Regulatory Agency recently published a Corporate Plan outlining their strategic priorities for the next three years. A key area of focus is international recognition, which follows their...more
Today marks the commencement of the legislation that extends the standstill period for EU CE-marked medical devices to continue to be placed on the market in Great Britain (England, Wales and Scotland)....more
The Medicines and Healthcare products Regulatory Agency (MHRA) recently published long-awaited guidance confirming that there will be a delay in the implementation of new legislation for the Great Britain market and an...more
The life science industry is a significant contributor to the global market, with companies developing and manufacturing a wide range of medical products and devices. However, due to the complex and highly regulated processes...more
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an update on the timing of the reform of the current UK legislation, the Medical Device Regulations 2002 (UK MDR), and the transitional arrangements...more
On 28 April 2023, the UK’s medical devices regulator, the Medicines & Healthcare products Regulatory Agency (MHRA), announced its intention to extend the acceptance of CE marked medical devices in Great Britain (England,...more