SGS Fimko receives significant EU status in the health technology sector
Finnish testing and certification company SGS Fimko Oy has been granted official notified body status under the European Union's IVD Regulation. This decision is a significant step for the company, which operates extensively within the healthcare and technology sectors.
The IVD Regulation, or In Vitro Diagnostic Regulation, governs medical devices used, for example, in laboratory tests and the diagnosis of diseases. The role of a notified body is to assess whether these products meet strict EU requirements before they can enter the market.
This new status means that SGS Fimko can now perform official conformity assessments for IVD devices. This is important as it ensures the safety and reliability of the devices for patients and healthcare professionals.
Receiving this certification is a testament to the company's expertise and its ability to respond to the EU's tightening regulations. The change strengthens Finland's role in the quality control of healthcare technology and supports the opportunities for companies in the sector to bring new innovations to the European market.