Euro Roundup: Commission seeks feedback on medtech joint scientific consultations
The European Commission has released a draft implementing regulations on joint scientific consultations under the Health Technology Assessment (HTA) Regulation. The draft implementing regulation covers medical devices and IVDs.In the draft, the Commission covers each step in the process, starting with when the Coordination Group will share dates on which device and IVD developers can request joint scientific consultations and ending with the outcome document and advice letter.
“Requesting expert panel consultation and joint scientific consultation on the clinical development plans is a new process for health technology developers of medical devices and [IVDs],” the Commission wrote. “Therefore, the health technology developers should be able to get assistance for the preparation of a timely and quality briefing package from the assessor and co-assessor for joint scientific consultation.”
Device and IVD developers can request a meeting with the assessor, co-assessor and the staff members of the HTA secretariat who are supporting the consultation. Companies should seek a meeting when asking for a joint scientific consultation. The Commission said the mechanism will allow health technology developers to “seek assistance relevant for the preparation of the briefing package.”
, and other evidence for a joint scientific consultation, including the list of questions. Applicants will submit the briefing package through the HTA IT platform. The HTA secretariat will request changes to the package if the assessor or co-assessor sees a need for further specifications, clarifications, additional information, data, analyses, or evidence.
The HTA Regulation is set to come into force on 12 January 2025. The Commission said the implementing regulation should apply simultaneously and seeks feedback on the draft by 26 November.
The timing has implications for setting request periods for joint scientific consultations. Typically, the Coordination Group will publish the dates of request periods for the following year by 30 November. There will be at least two request periods a year.
However, the implementing regulation also requires the Coordination Group to set at least one request period by 31 March 2025. This deviation from the typical timing means developers of medical devices and IVDs will be able to start making joint scientific consultation requests in 2025.
Press Release, Commission Consultation
Notified bodies call for MDR, IDVR changes amid troublesome delays to processes
Trade group Team-NB has emphasized the need to “simplify and consolidate divergent approaches” to processes involving notified bodies. This focus reflects the belief that most notified bodies can now take on work but are facing problems that slow processes.
Team-NB provided a positive update on notified body capacity last week. Most notified bodies have “capacity to accept applications and undertake conformity assessment activities quickly for most types of devices,” Team-NB said, but there are “some capacity restrictions for a limited number of device types.”
The trade group said some members “are facing difficulties in planning of their work and keeping their resources occupied.” The difficulties are caused by “delays in technical documentation submissions by manufacturers and in receiving responses to questions raised during the conformity assessment process.”
Team-NB discussed the impact of delays. “If such delays persist, it could lengthen the overall certification timelines and lead to potential bottlenecks in the future towards the end of the transitional timelines in 2027 and 2028,” they wrote. “Any modification of regulation and associated guidance should prevent to increase such delays.”
Team-NB has told the European Commission and Competent Authorities about the issues facing notified bodies. The industry group “emphasized the need to simplify and consolidate divergent approaches associated with a given legislative process/requirement.” For example, Team-NB said a “clear and consistent process” for resolving and immediately publishing device qualification and classification decisions would improve transparency and efficiency.
The group also favors “reviewing the data once during a life cycle process and eliminating the need to review and report on the same data as part of different processes, such as technical documentation.” Team-NB said the change would eliminate additional burdens and costs associated with reviewing the same data multiple times.
Press Release
EMA posts expert report on mobile health data for RWE in regulatory decision-making
The European Medicines Agency (EMA) has published an expert review report on using mobile health (mHealth) data for real-world evidence (RWE) in regulatory decision-making.
Experts prepared the report for the Big Data Steering Group that EMA runs with the Heads of Medicines Agencies (HMA). Expecting the role of mobile devices in drug development and regulation to increase, the group examines the impact digital tools and data could have on EMA and HMA decision-making. It evaluates when the technologies are reliable and valuable.
The expert review found that mHealth data, such as information collected by smartphones and wearables, is useful for medicine regulation in the planning and validity of applicant studies, understanding the clinical context, and investigating product associations on safety and efficacy outcomes. The report provides examples of how such data can be useful in each of those settings.
However, the expert review also identified operational, technical, and methodological issues. Regarding the operational challenges, the experts are primarily concerned about data protection, accessibility, and “a complex regulatory landscape.” The review found that regulatory requirements differ by mHealth device type and purpose, and there is limited guidance.
The authors said regulators should engage with developers and providers of mHealth tools “to ensure regulatory requirements for the use of mHealth data are understood and data protection is delivered by design.” Officials may also need to provide guidance on interpreting the data protection law in the context of using mHealth data.
The review concludes that better access to mHealth data must be facilitated. To further that goal, the authors have outlined “a rather ambitious proposal for the establishment of a common European patient data platform.” According to the report, the platform “would provide a stable and secure mechanism for patients to share data."
Expert Report
Other news:
The European Commission has adopted rules for managing the conflicts of interest of people involved in joint clinical assessments and scientific consultations under the HTA Regulation. The rules provide a framework for assessing declared interests to determine exclusions from and limitations to participation in joint work on HTA. Press Release
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