It will be exiting to follow the work of Martin Jakobsson and his team at TÜV SÜD, with Their newly established role as the first Danish MDR Notified Body is a significant milestone for Denmark’s life-science ecosystem..
The absence of a notified body in Denmark has been a major roadblock, hindering the flourishing of our dynamic medtech scene and overall value creation. Start-ups and small to medium enterprises (SMEs) have felt the impact. Historically, this situation has made Denmark and the EU a less attractive market for life science, prompting companies to explore other countries and geographies. At Contura International A/S , we’ve witnessed this firsthand.
Life science contributes to over 20% of Danish exports, but the rigide 2017 MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) regulations in the EU have adversely affected growth rates and the number of patents filed according to Medicoindustrien. Calling for a more flexible and pragmatic approach to fortify our ecosystem
With TÜV SÜD’s expertise and commitment, we’re optimistic that this new Notified Body will pave the way for innovative medical devices to swiftly enter the European market. Let’s strengthen our life-science landscape and foster more groundbreaking advancements.
🎉We’re thrilled to welcome TÜV SÜD as the first designated MDR Notified Body in Denmark! 🇩🇰🔍
Yesterday, Conturas — Ieva, Lotte, Carina, Lis and Frederik — joined the celebration and reception hosted in collaboration with Medicoindustrien. The event featured interesting speeches from Martin Jakobsson, Michael Dithmer as a representative of the Erhvervsministeriet (Ministry of industry, Business and financial affairs), Peter Huntley, Lina Gandløse Hansen as a representative Udenrigsministeriet (Ministry of Foreign Affairs) and Royth v. Hahn.
By establishing an MDR Notified Body in Denmark, the Medico industry is creating fertile ground for innovation within the life science sector. We anticipate that this move will not only address current bureaucracy challenges but also attract new funding to Denmark and the broader EU.
We’re excited to follow TÜV SÜD Danmark on their journey. Let’s pave the way for groundbreaking advancements in medical devices! 🚀💡
Lene Laursen, TÜV SÜD - Healthcare & Medical Devices
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Business Development Manager - Dexis
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