The Medicines and Healthcare products Regulatory Agency (MHRA) has announced plans to amend the Medical Devices Regulations 2002, SI 2002/618 to incorporate common specifications for high-risk in vitro diagnostic (IVD) devices. The changes include repealing Coronavirus Test Device Approvals (CTDA) regulations and introducing an accelerated approval process for CE-marked Coronavirus Test Devices. This decision follows strong support from consultation respondents for replacing the CTDA process with the common specifications. The changes aim to ensure that IVD devices meet high performance standards supported by clinical evidence and improve patient care and public health outcomes.

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the appointment of Jason Bonander as Chief Digital and Technology Officer, effective from late May 2026. Bonander joins from the US Centers for Disease Control and Prevention, where he served as Chief Information Officer and brings over 25 years of experience in technology leadership and health informatics. The appointment is intended to strengthen the MHRA’s expertise in health data and technology as it prepares to deliver a new five-year strategy and modernise regulation. His role will focus on transforming the agency’s services and digital platforms to support data-driven regulation of medicines, artificial intelligence and advanced technologies, with the aim of enabling faster, more efficient and more transparent regulatory processes while maintaining regulatory standards.

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the closure of the Innovative Devices Access Pathway (IDAP) pilot phase. The initiative selected eight medical technology companies to receive regulatory and access support through a Target Development Profile roadmap. The pathway, developed in partnership with NHS England and other healthcare bodies, aimed to accelerate development of innovative medical devices addressing unmet clinical needs in the NHS. Selected technologies include diagnostic tools for Alzheimer's disease, stroke identification, and cancer treatments.

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced an expanded partnership with the US Food and Drug Administration (FDA) to accelerate innovation in medical technologies and artificial intelligence (AI), improve patient safety, and reduce regulatory barriers between the two countries. At the AdvaMed conference, MHRA Chief Executive, Lawrence Tallon, outlined plans for deeper regulatory alignment, including the launch of the National Commission on the Regulation of AI in Healthcare, which features UK and US experts and global tech representatives. The Commission will guide safe and transparent AI adoption across the NHS. Additionally, the MHRA confirmed new international reliance routes that will enable faster UK market access for medical devices approved by trusted regulators such as the FDA, with legislative reforms expected in 2026 and implementation from 2027.

The Medicines and Healthcare products Regulatory Agency (MHRA) has awarded the first three Innovation Passports under its revised Innovative Licensing and Access Pathway (ILAP), designed to accelerate promising medicines to NHS patients. The pathway, which builds on a 2021 scheme, coordinates support from MHRA, NHS, NICE, Scottish Medicines Consortium and All Wales Therapeutics and Toxicology Centre from early development stages. The three selected therapies from 16 applications target rare diseases including neonatal ornithine transcarbamylase deficiency and Duchenne muscular dystrophy.

The Medicines and Healthcare products Regulatory Agency (MHRA) has released and updated a series of guidance documents to prepare organisations for the introduction of new UK clinical trial legislation coming into force on 28 April 2026. 14 total drafts now have been published, of which four are new draft guidance. These cover areas such as alignment with the Declaration of Helsinki, strengthened enforcement measures, archiving and record retention, and UK‑specific annotations to ICH E6(R3), a globally harmonised good clinical practice guideline, that explains how specific sections of the international text interact with the UK law which is to take precedence when conflicts arise. The MHRA is seeking feedback on whether the new draft guidance are easy to understand and implement. The deadline for submitting feedback is 8 February 2026.

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that its International Recognition Procedure (IRP) is live from 1 January 2024 and developers of new medicines can now submit applications online via the IRP. Authorisations will take between 60 to 110 days. The MHRA retains the ultimate authority to accept or reject applications submitted under the IRP. although the shared, global expertise inherent in the IRP process will lead to a more rapid, efficient, and cost-effective process for applicants. The MHRA will partner with regulators in Australia, Canada, Japan, Singapore, Switzerland and the USA, as well as the European Medicines Agency, individual EU Member States and those in the European Economic Area. To further streamline the IRP application process, the MHRA launched an ‘Eligibility Checker’ tool on 20 November 2023 which applicants have to use six weeks prior to making a full submission under IRP, to determine whether their Marketing Authorisation Application is suitable and to identify which route (A or B) to follow.

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced plans to establish a new team to provide dedicated regulatory scientific support for innovators who create novel antimicrobials and diagnostics to tackle global antimicrobial resistance (AMR). The new team is backed by £1.8m funding from the Department of Health and Social Care's Global AMR Innovation Fund (GAMRIF). The MHRA noted that it will provide these innovators with access early-stage regulatory advice via its Innovation Accelerator and advice on the preparation of calibrants and run controls necessary to ensure quality requirements are met.

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a new programme of events and increased engagement with industry, researchers, the NHS and government in Wales, following a board meeting in Cardiff on 18 May 2026. The initiative includes regular MHRA Liaison Days, which will bring MHRA representatives to Wales to host meetings and workshops on topics including innovation pathways, clinical investigations for medtech, regulatory support, and engagement throughout the product development pipeline. Local stakeholders in the health, care and life sciences sectors will also be able to book in-person surgery sessions with MHRA technical experts to facilitate more in-depth discussions.

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that Annex 2 of the International Council for Harmonisation (ICH) E6(R3) Good Clinical Practice Guideline has reached Step 2b and is now open for public consultation. This update aims to address the application of Good Clinical Practice to new trial designs and technological innovations, whilst strengthening a proportionate risk-based approach for clinical trials. As a full regulatory member of ICH since May 2022, the MHRA is actively seeking feedback from UK stakeholders to compile and coordinate comments for the ICH Expert Working Group. Interested parties can provide feedback either through the ICH website or via the MHRA's dedicated UK stakeholder consultation process.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a statement of policy intent regarding the relaunch of the Innovative Licensing and Access Pathway (ILAP) in March 2025. This announcement follows the success of the original ILAP, launched in 2021, which has awarded 166 Innovation Passports to date.

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that Kenneth George Harrison has been sentenced following his conviction for fraud offences relating to falsely certified medical devices supplied for use in UK hospitals. Harrison received a 3-year prison sentence, suspended for 3 years, and was ordered to complete 175 hours of community service and 10 days of rehabilitation. He was also disqualified from acting as a company director for eight years. Harrison and Medicina Limited were found guilty in July 2026 of fraud offences relating to P900 enteral feeding pumps, gastrostomy button devices and blunt fill needle devices that were supplied with invalid CE marking, giving healthcare providers false assurances that the devices met the necessary safety standards. The matter followed an investigation by the MHRA’s Devices Compliance Unit. During the investigation, the MHRA issued safety alerts, oversaw recalls and instructed Medicina Limited to stop further supply of the devices. The Crown Prosecution Service has also commenced confiscation proceedings under the Proceeds of Crime Act 2002 to recover any available funds from the criminal activity. A date has not yet been fixed for the sentencing of Medicina Limited.