The former Medical Device Directive (MDD) has been replaced by the new Medical Device Regulation (MDR).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.
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PRESS RELEASE |
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