Fagerhult’s medical supply units approved under the Medical Device Regulation
Fagerhult’s medical supply units are now approved under the new Medical Device Regulation (MDR). ”We see the benefit of offering our customers products that are already tailored to meet future requirements,” says Lars Handberg, Technical Product Manager for medical supply units.
The former Medical Device Directive (MDD) has been replaced by the new Medical Device Regulation (MDR). Suppliers must complete the transition by 31 December 2028 at the latest. Fagerhult is already delivering its medical supply units in full compliance with MDR.
”Fagerhult began early to ensure our documentation and processes were aligned with the new regulation MDR. As a result, Fagerhult’s units already meet the requirements of MDR 2017/745, Article 22,” says Lars Handberg.
As a consequence of this, the classic CE marking is removed. The reason is that according to the regulation, if you choose to follow Article 22, modular products - the ward panels should not be provided with an additional CE mark, (Article 22, Section 5) beacuse the included components are already CE marked.
”This doesn’t impact the functionality or safety of our products. It is simply a result of the legal framework. Our medical supply units comply with product standards and remain just as safe as before. However, it’s worth noting this in case anyone wonders why the CE marking is no longer present on the new products being delivered”, Lars Handberg explains.
Related News
Fagerhult is switching LEDs to reduce its climate impact
Fagerhult is implementing a major change with the aim of reducing the climate impact of its luminaires. By switching to the latest LED technology, Fagerhult is able to reduce annual emissions by 2,250 tonnes CO₂e from the products it sells. “A small change in each luminaire that has a huge overall impact,” says Niclas Thulin, Sustainability Manager at Fagerhult. The decision to replace the LED technology in the luminaires is a strategic one and has been made at management level. In practice, this means that the majority of Fagerhult’s Indoor range will be equipped with new LEDs featuring the latest generation of Flip Chip technology. This change will improve efficiency and reduce energy consumption by 5–10 percent, depending on the luminaire model. A small change with a big impact “Successful sustainability efforts entail focusing on the right things. In all, 85 percent of Fagerhult’s total climate impact across the entire value chain – Scopes 1–3, in other words – comes from the energy consumption associated with the use of our products. If we can improve efficiency and reduce electricity consumption from a significant portion of our product range, this will have a major impact,” says Niclas Thulin. Extended lifetime from 50,000 to 100,000 hours, with stable, high-quality light throughout. “It’s always difficult to predict exactly how much a change will save, since there are many factors at play. But by using data from 2025 – how many luminaires we sold and to which markets – and assuming that they are used for an average of 50,000 hours without lighting control, we estimate potential savings of approximately 2,250 tonnes of CO₂e each year*.” That is basically an entire forest: “That’s roughly equivalent to the amount of carbon dioxide absorbed by 90,000 trees in a year**. As a result, this change could have a significant impact on both our own and our customers’ environmental efforts.” A small LED upgrade can reduce emissions by approximately 2,250 tonnes of CO₂e per year – equivalent to the amount of carbon dioxide absorbed annually by 90,000 trees. Doubling the operating time The change also offers other sustainability benefits. The operating time of the luminaires is doubled from 50,000 hours to 100,000 hours. In the long run, this will entail a reduction in the consumption of resources such as raw materials and other materials. It will also provide financial benefits for our customers, who can make a secure and profitable investment in energy-efficient lighting with a longer working life. With this new technology, all luminaires will also have a Constant Light Output, providing stable, high-quality light throughout the luminaire’s working life. Put simply, good lighting ergonomics at work. How it works A small change that produces big results – what exactly makes the difference from a technical standpoint?“Our approach involves replacing standard LEDs with the latest generation of Flip Chip technology. In simple terms, Flip Chip has a more advanced design in which electrodes and other contact surfaces are positioned in such a way that they do not block or affect the light output. Flip Chip LEDs are simply more energy-efficient and robust,” explains Niclas Thulin.Luminaire models that already feature this type of LED will be upgraded to the latest generation of Flip Chip, as will all models that were previously equipped with standard LEDs. A win-win for everyone The cost of the upgrade will not be passed on to customers in the form of more expensive luminaires but will be financed through the logistical benefits that the change will bring. Sustainability Manager Niclas Thulin regularly meets customers in Fagerhult’s Sustainability Hub —bringing to life how informed lighting choices can deliver both climate and cost savings. “Larger purchase volumes and fewer item numbers mean we can offer these added benefits. Improved energy efficiency, a longer working life and better light quality, lower energy consumption and, above all, a significant contribution to the climate,” says Niclas Thulin.“Here at Fagerhult, we are committed to fulfilling our social responsibility and offering solutions that can address both climate change and the challenges associated with future electricity supplies. In our opinion, our customers shouldn’t have to choose between affordability and sustainability when it’s possible to have both. It's a win-win for everyone.” * Emission factors by country, based primarily on data from the Association of Issuing Bodies (AIB).** Based on average carbon dioxide absorption according to Ecotree.