SGS Fimko granted EU-level authority status in the field of health technology
The Finnish testing and certification company SGS Fimko Oy has received significant recognition from the European Union. The company has been officially designated as a Notified Body in accordance with the EU's IVDR (In Vitro Diagnostic Medical Devices Regulation). This means that the company is now authorized to assess and certify medical devices intended for in vitro diagnostics.
In vitro diagnostics refers to tests used, for example, to examine blood samples or other samples taken from humans in laboratories. These devices are critical in identifying diseases and planning treatment. The EU's tightened regulations require that such products undergo a rigorous inspection process before they can be brought to market.
The status received by SGS Fimko is an important step for the Finnish health technology sector. The role of a Notified Body is to ensure that products entering the market meet all safety and performance requirements set by the EU. This increases patient safety and ensures that the tools used in diagnostics are reliable.
The new designation strengthens Finland's position in European healthcare certification. Companies developing new health technology innovations will now find it easier to obtain the necessary regulatory assessments domestically. This may accelerate the availability of new and important diagnostic devices for Finnish and European patients.