SGS Fimko receives EU-level notified body status for medical devices
Finnish testing and certification company SGS Fimko Oy has received official notified body status in accordance with the European Union's IVD Regulation. This means that the company is now officially approved to assess the conformity of medical devices intended for in vitro diagnostics.
The IVD Regulation governs devices used in diagnostics, such as laboratory tests and equipment used for home testing. The role of a notified body is to ensure that products entering the market meet strict safety and performance requirements. This status is a significant recognition of the company's expertise and ability to operate in a demanding regulatory environment.
This new status strengthens Finland's role in the quality control of healthcare technology. SGS Fimko's role is critical, as it helps manufacturers ensure that diagnostic products are safe for use by patients and healthcare professionals. This contributes to patient safety across the whole of Europe.
The certification process is part of a broader EU-level effort to improve the oversight of medical devices. The approval received by SGS Fimko is an important step for the company, and it enables an even broader range of services for companies operating in the healthcare technology sector in Finland and abroad.