Euro Roundup: MedTech Europe welcomes IVDR proposals, calls for strengthening of some changes
MedTech Europe has voiced broad support for proposed changes to the In Vitro Diagnostic Regulation (IVDR), welcoming many proposals and pushing for the strengthening of some revisions.
Like when it reviewed the wider medtech revisions, the trade group evaluated whether to categorize the IVDR proposals under the headings “welcome,” “strengthen,” or “rethink.” MedTech Europe found aspects of the Medical Device Regulation proposals that it wanted officials to rethink. However, the trade group put all the planned IVDR changes in the welcome and strengthen categories.
MedTech Europe welcomed the European Commission’s proposal for proportionate oversight of low-risk devices, hailing it as a fix for the current application of largely uniform requirements across the primarily low-risk IVD sector. The trade group wants the Commission to strengthen the proposal by clarifying the legal provisions for routine procedures, thereby avoiding applying full authorization requirements to well-established activities such as blood draws and finger pricks.
The medtech industry wants the Commission to strengthen the principle that CE-marked devices should be the standard. With the plans expanding health institutions’ options to use their own tests, MedTech Europe warned the Commission risks creating a two-tier regulatory system. The trade group is concerned that different rules could apply to CE-marked and health institution tests used for the same purpose. MedTech Europe hopes to limit health institution tests to areas without CE-marked alternatives.
Orphan IVDs are another focus of the feedback. The Commission proposed defining orphan IVDs as tests used in diseases that affect fewer than 1 in 12,000 people a year. The definition differs from the orphan drug threshold, which is 5 in 10,000 individuals. MedTech Europe wants the Commission to use the 5 in 10,000 threshold.
“It would help ensure that these essential tests remain available, supporting timely diagnosis, safe treatments, and appropriate follow-up care,” the trade group said. “It also aligns with how orphan drugs are defined, making it easier to develop orphan diagnostics for those areas of medicine.”
EMA seeks feedback on expanding smoking guidance to cover tobacco-free products
The European Medicines Agency (EMA) has published a draft concept paper on plans to update guidance on developing treatments for smoking.
EMA’s current guidance on developing smoking cessation products came into force in 2009. Since then, use of tobacco-free nicotine products such as electronic cigarettes has increased. Addiction is a growing problem, EMA said, especially in adolescents and young adults. The smoking guidance was not designed to address such new types of nicotine addiction.
Officials plan to adapt the guidelines to new treatment needs. Plans include widening the scope to cover all sources of nicotine and addressing how to handle study populations that include people addicted to tobacco and tobacco-free products. Other areas of focus include nicotine addiction in adolescents and in pregnant and breastfeeding women.
EMA plans to define acceptable primary study endpoints. While long-term abstinence from nicotine is the ultimate goal, EMA will provide guidance on biomarkers and relevant timepoints to provide support for primary endpoints. Officials also intend to cover how to assess the risks and benefits of drugs to treat dependence on recreational nicotine products and the relevance of nicotine replacement therapy.
The agency is accepting feedback on the draft concept paper until 30 August. EMA plans to release draft guidance for consultation by the first quarter of next year. The draft will have a new title that reflects the expanded scope.
Swissmedic secures funding increase, provided it takes steps to improve performance
The Swiss Federal Council has offered a 14% increase in its financial support for the country’s therapeutic products regulator but made the boost contingent on changes including reduced staffing costs.
Last year, the Swiss Agency for Therapeutic Products (Swissmedic) began facing financial challenges as spending grew and a reduction in the levy on medicinal products took effect. In response, Swissmedic proposed to eliminate 45 positions over two years and reduce material costs by at least CHF 6 million ($7.6 million). The agency also outlined plans to increase income from medical device surveillance.
The Federal Council, the body that governs Switzerland, has agreed to support Swissmedic’s attempts to improve its financial position by approving the introduction of a registration fee for medical devices and increasing direct funding. Swissmedic is set to receive CHF 2.7 million more federal funding in 2027, on top of the CHF 19.3 million it received in 2026.
However, the Federal Council has tied the extra funding to the changes Swissmedic proposed last year. To receive the budget boost, Swissmedic needs to save CHF 15 million, split between CHF 9 million from staffing cuts and CHF 6 million from reduced material costs. The Federal Council will set its contribution for 2028 to 2030 when it approves new strategic objectives in the fourth quarter.
The new medical device registration fee will cover administrative work associated with the swissdamed database. Registration will be mandatory from 1 July, with a transitional period until 31 December. The update also ties the hourly rate Swissmedic charges to inflation.
BSI starts consultation into MHRA-sponsored standard for digital mental health tools
BSI is seeking feedback on a draft digital mental health technology (DMHT) standard sponsored by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
The draft standard provides recommendations for designing and conducting clinical studies to generate evidence for DMHTs that qualify as software as a medical device. Device developers will use the standard to guide clinical evidence generation before bringing DMHTs to market and in the early implementation post-market phase.
Pre-market, sponsors will estimate and evaluate the benefits and risks of DMHTs. Once a DMHT is on the market, sponsors will assess real-world performance and monitor effectiveness, safety, and engagement. The draft standard covers factors such as controls, sample characteristics, safety, effectiveness and engagement end points, and follow-up periods.
MHRA is inviting feedback from people in digital health, healthcare, academia, and patient communities. The consultation is intended to ensure the standard is robust, practical, and reflects a wide range of perspectives.
BSI is accepting feedback until 29 June.
EMA’s Emergency Task Force partners with African regulators to tackle Ebola outbreak
EMA’s Emergency Task Force has started working with the African Medicines Agency (AMA) and national regulators on the continent to address the Ebola outbreak.
Leveraging expertise from the WHO-AFRO African Vaccines Regulatory Forum, the agencies will discuss possible clinical trial designs and medical countermeasures to tackle the ongoing Ebola outbreak in the Democratic Republic of the Congo and Uganda. The World Health Organization declared the outbreak a public health emergency of international concern last month.
Working with AMA on a public health emergency for the first time, EMA is talking to developers, academia, and funders about advancing three vaccines, three treatments, and one potential medicine for post-exposure prophylaxis. By establishing regulatory criteria that ensure scientific rigor and speed, EMA and its collaborators aim to help rapidly advance candidates into late-stage clinical trials.
Other News:
EMA has answered questions about real-world data (RWD). The Q&A document clarifies some regulatory aspects addressed by EMA’s RWD guidance. Questions addressed include how to identify existing RWD sources and why to perform feasibility assessments. EMA Q&A
