Euro Roundup: EU countries start piloting coordinated reviews of medtech clinical trial filings

European Union Member States have launched a pilot coordinated assessment of clinical investigations and performance studies for medical devices.

Supported by the European Commission, the pilot will allow sponsors to submit a single application for studies in multiple Member States. The coordinated assessments are intended to offer more harmonized interaction with the Member States approving the clinical investigation or performance studies.

Sponsors will engage with all countries involved, which the organizers said could make communication clearer and more efficient while reducing delays. The pilot is also intended to give sponsors better visibility of evaluation processes across EU countries and a more efficient request for information process. Other claimed benefits include reduced discrepancies, simpler modification management, and faster decisions.

The pilot involves 21 of the 27 EU Member States, plus Norway. Sponsors seeking to run studies that involve at least two of the countries and meet certain other criteria can apply to participate in the pilot.

Experience gained during the pilot will inform work to build “a fast and fit for purpose EU system for coordinated assessment.” The EU changed the deadline for implementing such a platform last year to reflect delayed development of an electronic system on clinical investigations and performance studies.

EU Statement

UK vows to accelerate regulatory acceptance of alternatives to animal testing

The UK government has outlined its strategy for supporting the development, validation, and uptake of alternatives to animal testing in science.

Citing advances in artificial intelligence and genomics, the government representatives including former GSK executive Patrick Vallance said there is now a path to changing science’s reliance on animals. The technological progress has emboldened the government to try to create “a revolutionary research and innovation system that replaces animals with alternative methods wherever possible.”

Pursuing that objective, the government is setting up the UK Centre for the Validation of Alternative Methods to accelerate validation and regulatory acceptance of new methods and asking the Medicines and Healthcare products Regulatory Agency to publish accepted alternative methods and priorities for future development and validation. The goal is to clear a traditional barrier to method development.

“Companies often wait for regulators to approve new approaches before investing in them, while regulators require strong evidence of reliability before updating guidelines. This has historically slowed progress,” the government said. “We want this to change and in recent years, there has been a shift towards greater collaboration, with both sides working together to change the regulatory framework.”

The government has put animal tests into three baskets based on how close they are to being phased out. The first basket covers tests for which mature replacement technologies already exist and could be applied “in all but exceptional circumstances.”

Officials are aiming to apply only validated alternative methods for pharmacopoeial pyrogen testing by the end of 2025. The commitment is part of an international shift away from the rabbit pyrogen test. The roadmap through the end of 2027 includes work to replace adventitious agent testing in animals, replace animals used in skin and eye irritation tests, and phase out some preclinical animal testing of biologicals.

The phasing out of animal testing of biologicals where no pharmacologically relevant animal models exist will formalize the current case-by-case waiving of the need for in vivo data to enter the clinic. Officials aim to define and apply guidance that permits some first-in-human clinical trial submissions based on non-animal data by the end of next year.

The second basket covers tests with non-animal alternatives that require further development. Officials have set a 2028 to 2030 target for reducing or eliminating the use of animal tests in the second basket. The government has opted against granting licenses for forced swim tests as a model of depression. The three current licenses will end by 2028.

Other mid-term goals include reducing the use of dogs and non-human primates in dedicated pharmacokinetic studies by at least 35% by 2030. While there are currently no alternative methods which fully predict in vivo pharmacokinetics (PK), the government has identified opportunities to use AI and in vitro models. Researchers can also collect PK data in general toxicity studies.

The government has also committed to reducing the use of non‑human primates and dogs in dedicated cardiovascular safety studies by at least 50% by 2030. Again, officials see scope to combine the studies into general toxicity tests to reduce dedicated cardiovascular studies. Human-based in vitro assays, including organoid or organ-on-a-chip models, and in silico assays could later reduce the use of animals.

While there is a path to reduction and elimination for animal tests in the first two baskets, the third basket covers more complex endpoints for which no viable alternative methods currently exist. The only study in the third basket is the fish endocrine disruptor assessment test. Officials want to include validated alternative methods in UK regulatory guidance by the end of 2035.

Policy Paper

MedTech Europe warns post-market follow ups requested ‘almost by default’

MedTech Europe has raised concerns that regulators and notified bodies post-market clinical follow-up (PMCF) investigations “almost by default for most devices.”

Under the Medical Device Regulation (MDR), PMCF clinical investigations require manufacturers to proactively collect and evaluate clinical data on the use of some CE-marked devices in the real world. According to MedTech Europe, authorities are overlooking the need for PMCF to be proportional to the device’s intended purpose, characteristics, and risk-benefit profile.

In a position paper directed to the European Commission and the Medical Device Coordination Group, the trade group said healthcare professionals “have faced an overwhelming number of requests for PMCF clinical data.” Many requests cover products that have been on the market for years, MedTech Europe said, and it is “ethically questionable” to require clinical investigations of the established devices.

“PMCF data collection should prioritize specific device variants with higher risk profiles or where safety signals have been detected, ensuring resources (including medical staff) are focused on areas most likely to impact patient safety,” the trade group said.

The call for a risk-based approach to PMCF for low-risk devices with a demonstrated safety profile comes as EU officials consider revisions to MDR. MedTech Europe wants the EU to include a definition of a PMCF activity in the revised MDR.

Position Paper

EU health body proposes Critical Medicines Act changes to avoid disruption

A European Parliament Committee has proposed amendments to the Critical Medicines Act. The changes are intended to stop the European Commission’s proposal from causing “unintended disruptions.”

The Commission published its draft in March. After assessing the text, the Parliament’s Committee on the Environment, Climate and Food Safety (ENVI) flagged disruption risks related to overlapping environmental and chemical legislation. In response, the committee has proposed changes to establish a “balanced, data-driven approach” that safeguards drug supply while upholding environmental standards.

“The rapporteur believes that coordination between pharmaceutical, environmental, and chemical legislation is essential to prevent negative impacts on patient access to medicines and to ensure the sustainability and competitiveness of the European pharmaceutical and healthcare sectors,” ENVI said in its opinion.

ENVI wants all data related to environmental assessments, authorizations, and planning to be easily accessible and presented clearly through a centralized portal. The committee is aiming to avoid undue financial or administrative burdens.

ENVI Opinion

Euro Roundup: EU countries start piloting coordinated reviews of medtech clinical trial filings

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