Euro Roundup: EMA outlines improvements to medical device advice pilot

The European Medicines Agency (EMA) has published an interim report on a pilot project, setting out how it will improve the advice offered to manufacturers of high-risk medical devices in the future.

EMA began the pilot in February 2023 and aimed to provide free scientific advice to manufacturers of class III devices and class IIb active devices intended to administer or remove medicines. The agency fully implemented the program last month and has now shared details of what it learned through the pilot

The report covers the 20 advice procedures EMA completed by the end of last year. A further five cases were ongoing, and six applications were awaiting submission. EMA plans to include those cases in its final report but already has enough evidence from the completed cases to reach some conclusions.

Three-quarters of applicants were small and medium-sized enterprises (SMEs). EMA said the figure “indicates an unmet need for clinical development advice primarily for SMEs but also non-SMEs, as there are no other options in the EU to receive this premarket support to innovators for the design of their clinical investigations.”

The popularity of the pilot with SMEs revealed a need to refine the process to cater to the needs of smaller companies. EMA found that 72% of industry participants agreed or strongly agreed that the internal company resources and time required to participate in the pilot were manageable, while 18% disagreed. “Some manufacturers commented that for SMEs, the time and resource requirements for this type of advice was unexpectedly high,” EMA said.

Based on the feedback, EMA has streamlined the process by adopting “more focused timelines, replacement of meetings by written exchanges where appropriate.” Insights also lead the agency to make all meetings optional and “leave the flexibility to have exclusively written exchanges.”

EMA also identified a need for clarity on the expected time commitment, timelines, and expectations for both experts and applicants, as well as clearer requirements for the documents that need to be submitted. This finding prompted the agency to create a guide for experts and applicants that sets out expectations and instructions. EMA has also published a template for the briefing document for applicants.

The agency has sought to increase predictability and transparency by implementing a fixed timing for the advice. There is now a 60-day window from submission of the final briefing document. EMA also created a timetable setting out when each step in the process will take place based on when the final briefing document is submitted.

Interim Report

EMA rules evidence from AI-enabled liver biopsy tool is scientifically valid

EMA has qualified the first artificial intelligence tool for identifying the severity of metabolic dysfunction-associated steatohepatitis (MASH) in liver biopsy samples.

PathAI, a Boston-based developer of pathology tools, applied for qualification of its AIM-MASH AI Assist system and cited studies using samples from Gilead Sciences and Novo Nordisk as evidence. EMA published a draft opinion late last year, reaching the preliminary conclusion that the AI tool can be used in MASH trials to help pathologists at enrollment and at follow-up visits.

The latest opinion confirms EMA’s support for the tool, with the agency largely limiting the changes in the final version to minor grammatical and typographical tweaks. EMA added a line about pathologists accepting scores “within +/- 1 point per individual feature” in parentheses but its conclusions and reasoning are unchanged from the draft.

“The method can be used for all MASH clinical trials in which the histologic evaluation of liver tissue is used as part of the inclusion criteria, and/or efficacy evaluation,” EMA said. “The AIM-NASH tool is proposed as a supplement to pathologist review and is not a substitute. The tool is always intended to be used in conjunction with the assessment of a qualified liver pathologist.”

A single central pathologist can use the tool to inform the inclusion and exclusion of patients in Phase II and III clinical trials and evaluate the primary and secondary endpoints. EMA expects the pathologist to “review the output of AIM-NASH and take an active role in its interpretation by accepting or rejecting each of the [activity score] components and fibrosis stage.”

Press Release

MedTech Europe calls for ban on price-only contract awards, reduced tender burdens

MedTech Europe has called for a ban on awarding contracts based solely on price “to avoid negative impacts on competition and innovation.”

The trade group made the request in response to the European Commission’s call for feedback on the Public Procurement Directives. The Commission wanted to know if the directives have achieved their goals, which include fostering high competition in the single market, increasing the participation of SMEs in procurement, and simplifying and enhancing the flexibility of processes.

MedTech Europe called for the Commission to redefine contract award criteria. Currently, price is the primary or sole factor in awarding medtech contracts, the trade group said, and that focus “undermines the value of medical technology solutions, including their contribution to improve patient outcomes, enhance healthcare efficiency and overall management of the total cost of care.”

MedTech Europe wants the EU to establish a clear definition of “most economically advantageous tender (MEAT) awarding criterion reflecting Quality over Price to ensure harmonized understanding across Member States and procurers.” The trade group is pushing for price-only awarding to be limited to “exceptional cases with clear justification upfront.”

Across the rest of the position paper, MedTech Europe makes the case for strengthening market consultations, promoting flexible tender procedures and fostering innovation through procurement.

Press Release

MHRA starts monthly bulletin, redesigns alerts to improve safety communications

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched a monthly safety bulletin and redesigned safety alerts as part of a wider push to improve communication.

Last year, MHRA released a three-year plan for improving safety communications. As part of the strategy, the agency has created a bulletin that summarizes all MHRA safety alerts from the past month. The bulletin also includes a section of agency news about safety information. MHRA will send the bulletin to subscribers and publish the text online at the end of each month.

The agency said it has also redesigned its safety alerts “to make critical safety advice clearer and easier to action, utilizing color and relevant imagery to better engage healthcare professionals who often need to disseminate the information to their patients.”

MHRA shared details of the changes alongside guidance on safety communications concerning medicines, medical devices and other healthcare products. The guidance describes the different types of communications sent by MHRA and explains how to subscribe to receive updates. MHRA also outlines how it makes decisions about safety messages, focusing on its evidence sources and review process.

Press Release, MHRA Guidance

Euro Roundup: EMA outlines improvements to medical device advice pilot

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