Euro Roundup: Notified bodies call for access to Eudamed to enable move to risk-based oversight
A trade group has asked European authorities to give notified bodies access to the Eudamed database to empower them to deliver the risk-based oversight proposed in the pending medtech regulatory reforms.
Seeking to simplify the rules on medical devices and in vitro diagnostics, the European Commission has outlined plans for notified bodies to plan and conduct proportionate, risk-based surveillance activities. The model could apply to technical documentation assessments, periodic safety update report reviews, unannounced audits, and determinations of the certificate validity period.
Team-NB, an association that represents medtech notified bodies, supports the move to proportionate surveillance but, in a position paper published last week, flagged concerns with the implementation of the proposals.
“Risk-based regulatory oversight depends on timely access to comprehensive regulatory information,” Team-NB said. “To exercise the greater discretion envisaged by the proposal, notified bodies must have access to the same high-quality information on safety, clinical performance, and market experience that underpins proportionate regulatory decision-making.”
However, notified bodies currently lack access to crucial information in the European medtech database, Eudamed, Team-NB said. Current EU legislation gives notified bodies access to records related to their clients in the Eudamed market surveillance module, which went live this year. Notified bodies should also have access to client records in the planned vigilance and clinical investigation modules.
The Commission’s proposed reforms grant the European Medicines Agency (EMA) access to Eudamed and any electronic system referenced in the sections of the medtech regulations about the database. Team-NB has asked authorities to amend the proposal to say EMA and notified bodies will have access to all the referenced systems.
Giving notified bodies direct access to the systems would create “a single, authoritative source of safety, performance, and state-of-the-art information,” Team-NB said. Notified bodies believe the single data source will enable more efficient, risk-based oversight and reduce their need to consult multiple national and international databases.
“Today, notified bodies devote considerable resources to identifying and evaluating information on device safety, including incident characteristics, affected components, root causes, patient outcomes, and the frequency of similar events,” Team-NB said.
The work involves auditing manufacturers, suppliers, and subcontractors, reviewing scientific and clinical evidence, and monitoring vigilance data to determine the scope and timing of surveillance activities and assess whether new information affects the validity of issued certificates. Ongoing clinical investigations and performance studies provide data on rare adverse events and the current leading treatments.
Having a single, integrated source for incident reports and ongoing clinical investigations or performance studies would substantially cut “the time and effort for both initial and ongoing conformity assessment throughout a device’s lifecycle,” Team-NB said. The trade association predicted those benefits would lead to timely patient access to medical devices and preserve robust regulatory oversight and public trust.
EPC reactivates botulinum toxin working party to phase out lethal testing on mice
The European Pharmacopoeia Commission (EPC) has tasked its Botulinum Toxin Working Party (BOT WP) with helping to gradually phase out a test that kills mice.
Currently, the European Pharmacopoeia (Ph. Eur.) monographs on botulinum toxin type A and B include the mouse lethal dose 50% (LD50) assay. Such assays determine the dose of a substance that kills half of the tested animals. Botulinum toxin type A, which AbbVie’s Allergan sells as Botox, is used in the EU to treat neurologic, bladder, and skin disorders, as well as to reduce wrinkles.
As powerful toxins, botulinum products undergo LD50 testing. Recently, EPC reactivated BOT WP and tasked the working party with developing a roadmap for gradually phasing out LD50 testing from the Ph. Eur. monographs on type A and B forms of the toxin.
“This decision reflects the strong commitment and support to do so expressed by European regulatory authorities and manufacturers,” the European Directorate for the Quality of Medicines and HealthCare (EDQM) said.
EDQM is calling for people interested in shaping the future pharmacopoeial framework for botulinum toxin products to apply to become a member of the BOT WP. The working party’s tasks include revising the Ph. Eur. texts to phase out the LD50 assay and to anticipate new products, such as new serotypes and recombinant DNA-derived botulinum toxins, that are currently in the pipeline.
Days after posting the BOT WP update, EDQM shared details of a new general Ph. Eur. chapter on testing for procoagulant activity in immunoglobulin preparations. The chapter describes three methods for detecting the activity, which is typically caused by activated human coagulation factor XI and poses a potential safety concern.
EMA seeks feedback on draft qualification of Big Multiple Sclerosis Data network
EMA has started a consultation into its positive draft qualification opinion of the Big Multiple Sclerosis Data (BMSD) network.
Started in 2014, the BMSD network combines data from multiple national MS registries to support joint analyses. The team behind the project, which has been supported by grants from drugmakers including Biogen, Bristol Myers Squibb, Merck KGaA, Novartis, Roche, and Sanofi, sought a qualification opinion from EMA to conduct post-authorization safety studies (PASS).
Based on the evidence presented, EMA’s Committee for Medicinal Products for Human Use concluded that BMSD can be used as a data source for PASS intended to inform regulatory decision-making about disease-modifying MS treatments. Researchers will choose to use one, some, or all of the registries based on a mandatory study-specific feasibility assessment to ensure relevance to the research question.
EMA’s positive draft opinion reflects its conclusion that the network shows “a high completeness of core variables crucial for the conduct of PASS.” The availability of serious adverse event data has been shown, EMA said, addressing a key outstanding issue when the agency issued its initial qualification advice for the network in 2021.
The draft opinion is open for comment until 18 September.
MHRA requests quarantine of devices supplied in UK without conformity markings
The Medicines and Healthcare products Regulatory Agency (MHRA) has recommended the quarantine of six medical devices supplied in the UK without appropriate conformity markings.
MHRA made the recommendation after learning that the products do not comply with UK or EU medical device regulations. The agency has not identified a specific defect or safety concern associated with the products. However, the noncompliance with UK regulatory requirements means MHRA cannot guarantee the products’ safety, sterility, and performance.
The devices are used in clinical settings for blood collection and infusion, surgical and biopsy procedures, wound management, and skin preparation. The products were supplied by six different companies based in India.
MHRA wants individuals and organizations to check whether they have any of the affected devices in use or available for supply. Individuals and organizations with affected devices should stop using or supplying the products, quarantine any remaining stock, and use compliant alternatives, MHRA said.
Other News:
EMA provided an update on expert panel support for breakthrough medical devices, confirming that phase Ib of the pilot program will open on 1 September. Phase Ib is open to Class III products and Class IIb active medical devices intended to administer or remove medicinal products from the body. EMA Notice
EMA updated its guidance on implementing International Organization for Standardization requirements for identifying medicinal products in Europe. The update clarifies multiple points. EMA Guidance
