Euro Roundup: MHRA updates on medical device regulatory reforms

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published a roadmap of the actions it plans to take through 2026 to reform the medical device regulatory framework.

MHRA released the first version of the roadmap in January 2024, detailing the progress the UK had made since holding a public consultation into the post-Brexit future of medical device regulation in 2021, and looking forward to the actions MHRA and other bodies planned to take in 2024 and 2025.

The updated roadmap features four sections, the first of which features four changes to postmarket surveillance (PMS) that are scheduled to occur by the middle of 2025. MHRA lists January 2025 as the end date for debating and passing PMS legislation. The PMS regulation is set to come into force six months later. In between parliament passing and enforcing the law, MHRA plans to publish the first and final versions of its PMS guidance.

MHRA will work on new pre-market requirement regulations in parallel. Consultations on international resilience, in vitro diagnostics (IVD), marking and assimilated European Union law are the final items on the agenda for 2024. Early next year, the agency plans to share responses to those consultations and comment on feedback it received about coronavirus test device approvals and common specifications.

The notification period for regulations on the World Trade Organization website is in the calendar for next summer. Work on the identification of priority standards for designation, which is already underway, will continue into the autumn of 2025. Late in 2025, MHRA expects lawmakers to introduce and debate legislation on premarket requirements with a view to bringing the changes into force in 2026. The agency plans to publish guidance in conjunction with the legislative changes.

MHRA’s third workstream covers policy development. The agency is aiming to develop and publish policy intent for early access and innovation in the summer of 2025. Work on the policy is already underway. Development of new exceptional use authorization guidance is set to start soon with a view to publishing the document in March. Beyond that, MHRA will refine its health institution exemption policy and guidance to align with government strategy and develop and publish an IVD roadmap.

The final workstream is focused on software, including artificial intelligence and digital mental health products. MHRA is currently developing draft guidance for digital mental health technologies and aiming to publish the document in March. A consultation on good machine learning practice mapping is set to start around the same time. The final two items are guidance on AI development and deployment and software as a medical device cybersecurity, both of which will occupy MHRA from April to June 2025.

MHRA Roadmap

EMA seeks feedback on qualification of AI-based tool for assessing MASH patients

The European Medicines Agency (EMA) is seeking feedback on an artificial intelligence-based system designed to help pathologists score liver biopsies in metabolic dysfunction associated steatohepatitis (MASH) clinical trials.

PathAI, a Boston-based developer of pathology tools, applied for the qualification of the AI system to support the interpretation of MASH liver biopsies. EMA’s Committee for Medicinal Products for Human Use concluded the tool can be used in MASH trials to help pathologists at enrollment and follow-up visits and is now seeking feedback on its draft opinion. The comment window is open until 24 January.

EMA said existing manual histologic scoring systems have “suboptimal reproducibility,” even when only used by expert hepatopathologists. The agency cited evidence that inter-reader agreement is moderate, at best, for some liver characteristics. There is variability between assessments of fibrosis and steatosis.

PathAI sees its tool to improve accuracy, repeatability and reproducibility. The tool determines a disease activity biomarker based on steatosis, lobular inflammation, and hepatocyte ballooning, three liver attributes used to assess MASH activity, and the fibrosis stage in biopsies. Pathologists review the output of the AI and accept or reject each of the liver attributes and fibrosis stage.

“The main results of the evaluations contained in the clinical validation indicate that the algorithm-based evaluation of histology as compared to individual pathologist reads proved to be non-inferior for the features of fibrosis grading, and steatosis stage, and proved to be superior regarding the stage of lobular inflammation and hepatocellular ballooning,” EMA said.

EMA said “optimization of the model is highly encouraged” but the positive draft opinion only covers the tool in its current “locked” state. If PathAI adds more training data, the tool may require requalification because the update will be classed as a major change.

Draft Opinion

EMA group puts 3D printing, decentralized manufacturing on regulatory roadmap

EMA’s Quality Innovation Group (QIG) has published its three-year rolling work plan, providing a look at its goals for guidance development and other activities from 2025 to 2027.

QIG supports the translation of innovative approaches to the design, manufacture and quality control of medicines. As part of that agenda, the EMA expert group is planning to lead preliminary considerations on pharmaceutical process models in 2025 and 2026. The work is intended to lead to an EMA guidance document.

The expert group will also provide input on three guidance documents being developed by other parts of EMA. The input will inform the development of question-and-answer documents on 3D printing and decentralized manufacturing, plus a good manufacturing practice annex on computerized systems.

Plans for 2026 and 2027 are less defined at this stage. QIG said it will “identify future guidance needs based on the development and maturity of other innovative manufacturing technologies and relevant discussions with stakeholders.”

Work Plan

EudraVigilance pilot set to extend into 2025 as wait for regulatory update continues

A pilot on signal detection in EudraVigilance will continue beyond the end of the year because an update of the implementing regulation is unlikely to be published before the first half of 2025.

EMA began the pilot in February 2018 to further the implementation of legislation passed in 2012. The law requires marketing authorization holders to continuously monitor the EudraVigilance database and tell EMA when they find validated signals. EMA has limited the requirement to certain active substances during the pilot project.

The agency previously extended the pilot to the end of 2024 and has now pushed the termination date into 2025. EMA plans to terminate the pilot once the amended implementing regulation comes into force. The amendments will reflect the experience gained during the pilot. EMA also updated the list of substances and products subject to worksharing for signal management last week.

EMA Update

Other News:

EMA has updated a question-and-answer document on the quality of medicines. The document features two new questions that allowed EMA to explain when companies should use the terms “granules in capsule for opening” and “oral powder in capsule for opening” and what additional considerations apply to products that carry the terms. EMA Q&A

EMA has released a draft guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration for consultation. The document covers the information companies need to provide when applying for marketing authorization. EMA is accepting feedback until 31 May. Draft Guideline

Euro Roundup: MHRA updates on medical device regulatory reforms

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