Danish health minister: Europe must act on China

“We need to foster collaboration between clinicians and companies, not between public hospital departments.”

So says Danish MP Freja Brandhøj from the opposition liberal party, Liberal Alliance, who is the party’s spokesperson for both health and entrepreneurship.

Freja Brandhøj brought a medical device – invented by her surgeon husband – to the European Affairs Committee meeting, where Denmark’s Social Democratic Health Minister, Ida Auken, presented her innovation-friendly position on the revision of the European medical device regulations.

The device is used for pressure equalisation via balloon dilation, which can serve as an alternative to sinus and ear surgeries. After four years, this delicate device in two versions is now on the verge of final approval.

Freja Brandhøj explained in a passionate way the bureaucratic burdens and requirements that innovating doctors, nurses and healthcare staff have to fulfil, such as ISO certification, validation, compliance and adherence to the MDR and IVDR.

Requirements are not as stringent in the public sector as in the private sector when it comes to years of testing and documentation for “in-house” inventions.

“A hospital’s name cannot substitute for documentation.”

According to Brandhøj, the regulatory work alone, together with quality assurance and documentation, requires the equivalent of two full-time positions for a year, at a total cost of around €2 million.

How Europe can compete with China

Meanwhile, Danish Health Minister Ida Auken warns that China is rapidly strengthening its position in the healthcare sector. She believes action is needed to prevent China from “taking over the entire market”.

“We cannot compete using China’s model of state-led innovation. Instead, we must compete through close partnerships and public-private collaboration, rather than relying on state-owned enterprises,” Ida Auken observes.

Regulations must be simpler, processes faster and the system more efficient, so that we foster competitiveness and innovation. Simplifying regulations should not result in reduced safety. It would free up resources for innovation, she says.

This demonstrates an awareness that these simplifications benefit patients, the healthcare system and companies alike

Mads Koch Hansen, director of Medicoindustrien (Medtech Denmark)

The simplifications include the removal of recertification (the renewal of certificates every five years) and allowing healthcare institutions to share medical devices with other healthcare organisations.

In the European Commission's revision of the two medical device regulations, the proposal on the reuse of single-use medical devices remains the primary concern for the industry.

The proposal entails a reversal of the burden of proof: manufacturers would be required to document that the device cannot be safely reused. This is unreasonable, warns Mads Koch Hansen, director of Medicoindustrien (Medtech Denmark).

“Devices approved only for single use cannot be used multiple times. Doing so compromises numerous criteria for materials and safety. Liability for improper use in that case could fall back on the manufacturer, which is unfair,” says Mads Koch Hansen.

Calls for scrapping the five-year rule

From his perspective, however, the political process is otherwise proceeding steadily. He is optimistic about reaching a compromise, given that the legislative process for the EU proposal – dating back to December 2025 – is fast.

He notes that Denmark is playing a very active role in this matter, praising both former Health Minister Sophie Løhde and her successor, Ida Auken.

“This demonstrates an awareness that these simplifications benefit patients, the healthcare system and companies alike,” he points out.

The industry is particularly pleased that the requirement for recertification every five years is being dropped, as this process is costly without contributing to patient safety.

“Recertification amounts to organised waste, given that continuous market surveillance is already in place. Companies are forced to dedicate staff to renewing approvals. We know that products are often withdrawn from the market because recertification isn't cost-effective, and that does not benefit patients,” says Mads Koch Hansen.

Dispute over in-house manufacturing

He calls on the EU to also address the cumbersome and resource-intensive approval processes for drug-device combinations such as Novo’s insulin pen, where the company manufactures both the medication and the device.

“This is particularly important for Denmark, as it is a key issue for certain companies. The proposal does not address this,” says Mads Koch Hansen.

Currently, hospitals can produce their own medical devices for five years without undergoing the same approval process as private companies. The European Commission proposes a 10-year period for in-house inventions, while Denmark has adopted a stricter stance – agreed upon with centre-right opposition parties – advocating for a shorter exemption period.

An appropriate exemption period would be three years, after which the standard approval process would begin, or the hospital would hand the task over to a private company via a public-private partnership (PPP), according to Mads Koch Hansen.

In any case, the scope for Rigshospitalet in Copenhagen, Karolinska University Hospital in Stockholm and other hospitals to use devices developed in-house by other public health organisations is being expanded.

Hopes for an EU compromise

Ireland and Germany are other major players in the medical device sector. He senses that these countries’ positions are relatively aligned, which could hopefully lead to an agreement within the Council of Ministers. The mood in the European Parliament is also constructive, he notes. The Danish, Swedish and Finnish medtech industry associations are aligned.

“This demonstrates an understanding that the entire industry is under pressure due to the geopolitical situation and the very high costs associated with approvals and production in Europe,” concludes Mads Koch Hansen.

The US as a role model

Politicians these days talk a great deal about doing away with red tape, and the current revision is the 12th so-called omnibus proposal, which simplifies rules and processes.

Mads Koch Hansen has a far-fetched dream.

In the US, you receive a response from the FDA (US Food and Drug Administration) within six months. Mads Koch Hansen envisions a more ambitious Europe that grants approval even faster, within three to five months.

“In Europe, one, two, three years can pass without a decision, and at a late stage, you may be asked to provide additional documentation. We want predictability and transparency. In Europe, the certification and approval process is outsourced to supervisory bodies – entities that simply charge the companies fees if the process drags on.”