TÜV SÜD – The first MDR-notified body in Denmark
TÜV SÜD – The first MDR-notified body in Denmark

Case

TÜV SÜD – The first MDR-notified body in Denmark

Case

TÜV SÜD – The first MDR-notified body in Denmark

With the designation of TÜV SÜD in Denmark in 2024 the Danish, European and global Health Technology industries, and the broader Life Science ecosystem, gained access to a Denmark-based notified body for certification of medical devices under the EU Medical Device Regulation (MDR 2017/745). This means medical device manufacturers now have a local, responsive partner to support their regulatory journey towards market access. For SMEs, start-ups and their venture capital backers, this is particularly noteworthy as they often face challenges navigating the mandatory conformity assessment of their innovative devices.  

When

Medical device regulation in brief

Before medical devices can enter the EU market, they must be certified by a notified body in accordance with their risk classification, ranging from Class I (low risk, only devices with a measuring function, that are reusable or sterile), through Class II a and II b (medium to high risk), to Class III (high risk). The transition from the Medical Device Directive (MDD) to the more stringent Medical Device Regulation (MDR) introduced a number of regulatory challenges for all stakeholders. One major bottleneck has been the lack of available notified bodies, coupled with limited transparency throughout the conformity assessment process. That challenge is now being addressed with TÜV SÜD’s presence in Denmark as a key part of the solution.

Sustainable market access for Health Tech companies operating locally or regionally in the EU - or even globally

The presence of an MDR-notified body in Denmark underscores the strategic importance of the Life Science Industry, incl. the Health Technology manufacturers, to the Danish economy. For these players, having a highly customer-focused certification partner is critical when navigating the assessment process.

TÜV SÜD’s customer journey has been uniquely mapped to reduce complexity, from pre-application through to certification. This approach improves predictability and transparency, enabling companies to progress their market entry strategies in parallel and be ready to launch as soon as the certification mark can be placed on the device.

Throughout the conformity assessment process TÜV SÜD works closely with manufacturers to avoid delays and eliminate uncertainty over next steps. 

“The feedback from our first couple of customers has been extremely positive. We proudly conclude that our customer assessment procedures in fact deliver transparency, consistency and predictability throughout all stages of the customer journey from pre-application to the decision on the certificate without compromising product safety or regulatory compliance at any time.”

Martin Jakobsson

Vice President TÜV SÜD Medical & Health Services Northern Europe

Beyond being a certification leader, the TÜV SÜD Group also operates independent testing laboratories worldwide. Their testing services cover the full spectrum such as biocompatibility, chemical characterisation, electrical safety, EMC, microbiological and packaging tests, as well as advanced areas such as cybersecurity testing.

Invest in Denmark: Opening doorsto the Danish ecosystem

Back in October 2020, TÜV SÜD’s German-based headquarters reached out to Invest in Denmark with initial ideas for opening a Northern European unit. We facilitated introductions to the Danish Health Technology eco-system, as well as key potential collaborators.

TÜV SÜD was impressed by Denmark's high level of digitalisation, high levels of trust and transparent public processes. The flat organisational structures and easy access to authorities and ministries were also highly valued when choosing Denmark as the base for their Northern European unit. 

“TÜV SÜD represents transparency, efficiency and innovation, qualities that align well with Danish business culture. Denmark is home to a mature and innovative life science sector, including a fast-growing Health Technology subsector. I believe that TÜV SÜD’s establishment is a valuable contribution to the Danish life science ecosystem, and to Danish society as a whole.” 

Vanessa Vega Saenz

Director, Invest in Denmark

Get in touch

Want to know more?

You are always welcome to contact our Health Technology advisors to learn more about the free of charge services we offer and how the Danish government supports the research and development industry. All inquiries are treated confidentially. 

Copenhagen

  • Sarina Lohmann

    Title: Special Advisor – Maritime and transport – Analysis & Partnerships

    Area: Copenhagen

    Phone: +4533920423

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