Euro Roundup: Commission gives medtech companies 5 years to adapt to symbols standard
The European Commission has adopted new harmonized standards for medical devices and diagnostics but established a five-year transition period to give manufacturers time to adapt their processes.
Amending two implementing decisions, the Commission outlined efforts to revise harmonized standards. The affected standards include EN ISO 15223-1:2021, which specifies the symbols that manufacturers can use to express information on a medical device, its packaging, and accompanying materials. A recent update mandated the use of “EU REP” instead of “EC REP” to indicate “authorized representative.”
The Commission gave manufacturers five years to implement the change considering the significant time and money involved in making “labeling changes in manufacturing and distribution of devices, taking into account the processes involved, both at EU and international levels.”
The Medical Device Coordination Group (MDCG) provided more information on the new standard and the transition period in an appendix to its guidance on standardization for medical devices. The change to “EU REP” is purely editorial in nature, MDCG said, and manufacturers do not need prior approval from a notified body to make the labeling change.
For the next five years, manufacturers can ship devices with one or both symbols “EU REP” and “EC REP” on different levels of packaging, provided that the information on the authorized representative remains clear and intelligible. Companies have until 17 June 2031 to switch to “EU REP.”
Implementing Decision, MDCG Appendix, More
Notified bodies warn proposed SME support risks destabilizing sector, delaying launches
Notified body association Team-NB has warned that proposed fee discounts for micro and small medical device manufacturers risk destabilizing the sector and delaying access to products.
As part of planned revisions to the medtech regulations, the European Commission has proposed giving micro and small enterprises an up to 50% discount on notified body fees. The discount “raises substantial concerns regarding fairness, feasibility, and system sustainability,” Team-NB said. The association argued that positioning notified bodies as the mechanism to “sponsor” small companies is a “false premise.”
Team-NB’s concerns center on the workload associated with conformity assessment applications from smaller companies. When working with smaller companies, notified bodies typically ask more clarification questions, find more nonconformities, and receive repeated resubmissions because of immature or incomplete quality management systems and technical files, Team-NB said.
The association attributed the filing difficulties to small companies’ “limited embedded regulatory affairs expertise.” The Commission’s plans to free small companies from the need to have a person responsible for regulatory compliance risk exacerbating the difficulties by “reducing a critical mechanism intended to ensure regulatory competence at source,” Team-NB said.
“The cumulative effect is a misalignment between policy intent and operational reality,” Team-NB said. “Measures intended to support micro and small manufacturers risk destabilizing notified bodies, increasing bottlenecks, and ultimately impairing market access for the very entities they aim to help.”
Team-NB has proposed alternative ways to support small companies, including systematically offering applicants a “structured dialogue opportunity” for free each time a formal round of questions is issued in a conformity assessment. Other suggestions include offering remote or hybrid audits, funding programs that support small companies, and allowing a risk-based approach to post-certification sampling.
UK readies AI regulation proposals after finding strong consensus for significant reforms
The UK’s National AI Commission is preparing to publish its recommendations after a consultation found a “strong consensus for significant regulatory reform.”
Established to inform the future regulation of AI in healthcare, the Commission plans to publish its final recommendations to the Medicines and Healthcare products Regulatory Agency (MHRA) in late summer. The government, led by MHRA, will consider the advice and outline its response and next steps, setting the future direction of AI regulation in healthcare in the UK.
The Commission will base its recommendations on the findings of research, including a call for evidence that received 761 unique responses. The responses included submissions from 86 industry groups, 13 regulators and government bodies, 60 people working in industry, and 37 regulatory professionals.
An industry organization told the Commission that the UK's existing regulatory framework provides a strong foundation for patient safety. However, the organization added, the framework “was not designed for AI systems that are adaptive, probabilistic, multi-use, and capable of ongoing change after deployment.” That assessment led the organization to recommend improvements focused on “risk-based adaptation, clarity, and proportionality rather than wholesale replacement of existing regulation.”
The suggestion was echoed across the responses, with the Commission finding broad support for “a proportionate approach that is risk-based, considers patients’ safety and fairness, with clear practical guidance, and addresses existing duplication and fragmented oversight.” A risk-based approach is vital to minimizing the cost and burden of compliance, an industry group told the Commission.
Evidence collection is continuing, building on multiple research and engagement activities undertaken by the Commission since late last year. Liability is a focus of the ongoing research, reflecting the “persistent uncertainty identified in earlier work” by the Commission. MHRA is talking to regulators, legal experts, and other people to develop approaches to liability in AI-enabled healthcare.
MHRA forms liaison program with FDA to strengthen transatlantic regulatory cooperation
MHRA has formed a liaison program with the US Food and Drug Administration (FDA), creating dedicated roles to support interactions between the agencies.
Creating reciprocal liaison officer roles at each agency is intended to “enhance day-to-day collaboration, support scientific exchange, and enable faster, more coordinated approaches to emerging regulatory challenges and decisions,” MHRA said. The agencies hope stronger communication and more effective sharing of regulatory insights will enable them to respond faster to scientific and technological advances.
“This will help product developers cross the Atlantic, in both directions, because our regulatory decisions will become more closely aligned, reducing friction to market from the UK to the US and vice versa,” MHRA Chief Executive Lawrence Tallon said.
The liaison program continues MHRA’s post-Brexit push to forge ties with other regulators. Having left the European Medicines Agency, MHRA has joined the Access Consortium, committed to working more closely with FDA, and proposed reliance mechanisms to leverage the work of peer agencies.
Swissmedic makes SEND format mandatory for certain nonclinical data submissions
The Swiss Agency for Therapeutic Products (Swissmedic) has made it mandatory to submit nonclinical study data in the SEND format in some situations.
Swissmedic said the format is mandatory when filing data for new authorization applications for human medicinal products with new active substances “if submission to the FDA is planned or if the submission has already been made.” The change took effect on 15 June. Swissmedic began accepting data in the SEND format in 2024.
SEND, an acronym for Standard for the Exchange of Nonclinical Data, enables structured, transparent, and efficient evaluation of study data, Swissmedic said. The agency uses the datasets for additional electronic analysis and to support scientific evaluation. Swissmedic updated its forms and guidance documents to reflect the mandatory use of the format.
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MedTech Europe and 29 other associations have warned European legislators against “rushing through half measures” as they debate simplifying the digital regulatory framework. The European Parliament aims to develop and adopt its position by February. MedTech Europe wants the Council to give itself “sufficient time for reflection” to ensure it seizes the opportunity for simplification. Joint Letter
