Last week, we reported on an emerging trend in the European medical cannabis industry, which is seeing regulators in incoming markets favour alternative modes of administration, challenging the ubiquity of dried flower.
Medical cannabis flower is still overwhelmingly dominant in Europe’s largest existing markets. According to Prohibition Partners, as of December 2025, 77% of all available products in the UK are dried flower, increasing to over 90% in Germany.
Yet, with both Spain and France expected to launch national frameworks this year, effectively omitting traditional flower from their markets, a significant opportunity for manufacturers able to offer alternative administration formats is emerging.
While many consumer-grade devices already exist on the market, those with CE certification, meaning they have passed rigorous European regulatory scrutiny regarding safety, reliability and repeatability, are less readily available.
“Achieving CE certification for a medical device is not trivial as it requires significant multi-year investment, documentation, and independent assessment by a notified body,” Juan Martinez, CEO of Curaleaf International, which launched the UK’s first CE-Certified liquid inhalation device last September, told Business of Cannabis.
“Companies don’t pursue that kind of certification unless they’re committed to operating within long-term medical frameworks.”
The sealed capsule compromise
A critical differentiator between the incoming frameworks is that while Spain will have no flower at all, France has managed to carve out a middle ground.
France’s incoming regulations permit dried flower, but only when sealed in single-use capsules compatible with CE-certified medical devices. This compromise manages to address regulators’ concerns about diversion and standardisation while preserving patient access to flower-based treatment.
Benjamin Alexander Jeanroy, Managing Partner at Paris-based consultancy Augur Associates, explained: “Spain bluntly prohibits the flower, and that’s it. France found a solution with the authorisation of sealed capsules.
“It’s a little bit more difficult for providers and producers, but it still allows it. So it’s not only resolving the issues that flower brings, but it’s also bringing forward a solution that brings the capacity to access flower.”
Jeanroy characterised the sealed capsule requirement as France’s attempt to “overcome the issues that flower brings – its stigmatisation, and the excuse being used by prohibitionists to prohibit medical cannabis.”
By requiring pharmaceutical-grade device integration, France’s framework sidesteps the perception problems that have plagued the UK and Germany’s more open flower market while maintaining patient choice.
For manufacturers, this framework creates both opportunities and barriers to entry. As a device cannot be marketed or distributed legally within the EU without CE marking, those who have failed to invest the considerable time and costs associated with it find themselves locked out of the market before it’s launched.
“The shortage isn’t CE-marked devices themselves,” Martinez observed. “It’s cannabis companies with established partnerships or proprietary certified devices. That’s becoming a significant competitive advantage as these frameworks materialise.”
What medical device certification demands
CE certification under the Medical Devices Regulation requires cannabis inhalation devices to meet Class IIa standards. This category is for devices with ‘notified body involvement’, such as hearing aids, ventilators, ultrasound scanners and catheters.
“You don’t go for a Class IIa medical device approval if you’re just looking for a quick win,” Martinez said. “You do it because you believe in meeting pharmaceutical-grade standards and cannabis treatment being part of mainstream healthcare.”
Curaleaf began developing its QMID (Quantum Metered Inhalation Device) alongside Jupiter Research LLC, which was involved in the launch of a second CE-certified device in partnership with Somai Pharmaceuticals and Airo a month later, some five years ago.
“We made a deliberate decision at Curaleaf to invest in developing a certified medical device because we believe medical cannabis should stand alongside other prescribed treatments under the same scrutiny.”
“It wasn’t the easiest path – especially as we were the first – as it required time and significant resources, but meeting Class IIa standards confirms that the device satisfies established regulatory and quality criteria. That level of quality assurance simply isn’t present with off-the-shelf vaporisers.”
As Spain and France’s requirements materialise, the five-year investment timeline that once looked speculative appears increasingly prescient.
The clinical case for liquid inhalation
Beyond regulatory compliance, Martinez argues that liquid inhalation addresses genuine clinical needs that flower struggles to meet consistently.
“Liquid inhalation allows for consistent and controlled dosing,” he explained. “For patients, it means a fast onset of action with repeatable effects and doses. They can expect a similar experience each time they medicate, which is important when you’re managing symptoms and need reliable relief.”
For prescribers operating within conservative hospital-led frameworks, this consistency is paramount.
“It’s a lot easier to say ‘use X milligrams via this inhaler, up to Y times a day’ and know what that means, versus trying to estimate doses from inhaling flower, where technique and individual variation can lead to different results.
“Certain patient groups, for example, those with severe asthma or chronic lung conditions, might benefit from a vaporised liquid formulation because it can be gentler on the lungs than smoking raw flower. Additionally, some conditions require very fine titration of dosage – neuropathic pain, severe spasticity – and a device can help dial that in more systematically.”
However, Martinez was careful not to position liquid inhalation as universally superior. “This isn’t about declaring liquid formats ‘better’ across the board or trying to replace flower entirely. Cannabis flower remains clinically valuable for many patients,” he said.
“A lot of people get needed results from vaporizing or even smoking flower, and they appreciate the broader spectrum of cannabinoids and terpenes in the natural form. We believe that the future of medical cannabis is not about one format winning out over another but rather it’s about offering multiple, clinically appropriate options within a regulated framework.”
Cost barriers
Higher regulatory standards inevitably raise questions about affordability and the risk of creating a two-tier system where only well-resourced patients can access pharmaceutical-grade devices.
While Martinez cited cost as a ‘legitimate concern’, as the market matures he believes ‘competition and scale’ will bring costs down.
Martinez acknowledged the concern directly. “Cost is a legitimate concern. Higher regulatory and manufacturing standards can initially increase prices, especially before reimbursement pathways exist.”
While the details of reimbursement in the French market are still being decided by the HAS, it’s likely a considerable portion of the costs of both the devices and the metered doses will be covered for patients.
With France offering both a middle-ground on the question of health care, and likely cost relief for its patient population, Jeanroy states that he is confident ‘France is going to be the model, not Germany, in the development of the medical cannabis framework in Europe at the national and the supranational level.’
As such, he believes a general shift away from flower will ‘definitely be a trend in Europe’ in the coming months.
Martinez offered a similar prediction, noting that he expects ‘diversification rather than convergence’, with already established markets continuing to support flower, ‘while newer frameworks will lean into standardised preparations and device-based delivery.’
He concluded: “The demand will always be there; the question is how much of it we can fulfil through regulated, safe channels. I think by this time next year, we’ll see a noticeable shift with more demand being met inside the legal system than outside of it.”
These challenges and opportunities will be central topics at Cannabis Europa Paris on February 19, where industry leaders will examine whether France’s unique approach justifies the countless delays in the eyes of patients.
