The Slovenia Times

Better regulation of medical devices market needed

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MedTech forum. Photo: Boštjan Podlogar/STA

The market for medical devices in Slovenia is growing fast but is inadequately regulated, a forum dedicated to the topic heard on 28 September. There are a total of 3,000 suppliers, but only 13 are officially registered in line with EU rules.

Organised by MedTech, the medical branch of the Chamber of Commerce and Industry (GZS), the forum discussed the problems of poor regulation of medical devices.

MedTech Slovenija president Mojca Šolinc said that the Agency for Medicinal Products and Medical Devices was unable to conduct effective oversight due to inadequate legislation.

"We all have to strive for patients to get a safe and effective device that complies [with the relevant standards]. This is the only way to avoid unwanted complications and additional cost," she said.

Šolinc cited a study that showed that complications in diabetes treatment accounted for half of all funds earmarked for the disease.

Bojana Beović, the president of the Medical Chamber, underlined that medical outcomes depended on good medicines and medical devices, adding that appropriate legislation is needed for the field to be able to develop.

Medical Chamber vice president Boštjan Kersnič meanwhile pointed to long waiting periods, saying they have to be cut, including by using modern technology, which may help classify patients according to the urgency of treatment.

GZS director general Vesna Nahtigal said that the medical devices industry was a vital part of the country's economy. "We have good reason to be proud of Slovenian companies from this sector that have become trustworthy suppliers.

"They created EUR 480 million in revenue last year, which was over 6% more than in 2021. Export of medical devices has grown by 15% in the past three years, while import has only grown by just over 8%, an indication of how successful Slovenian companies are," Nahtigal said.

Petra Zoellner of the umbrella MedTech Europe association talked about EU requirements, saying that the industry faced a number of challenges in the coming months and years as it strives to meet the many requirements set for different devices.

Health Ministry state secretary Valentina Prevolnik Rupel pointed to the importance of collecting outcome results, adding that Slovenia was the first EU country to start this.

The first day of the forum focused on two increasing social and economic problems: diabetes and chronic wounds. As part of this, Petra Došenović Bonča of the Ljubljana Economic Faculty, presented a study about the cost of diabetes treatment in Slovenia.

Between 2019 and 2022, the total cost amounted to EUR 174 million, or nearly 5% of the healthcare purse and out-of-pocket payments combined, half of which was used to address problems that occurred due to complications.


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