Important notification for IVDR Class C device manufacturers

Are you a manufacturer of legacy IVD devices that did not require CE certification under IVDD and your device will be classified as a class C device under IVDR?

→ Now is the time to submit the IVDR CE Certification application to a Notified Body as the deadline for application is quickly approaching; 26 May 2026. It is important to remember that formal application is a legal requirement and necessary to continue placing the devices on the market. The next relevant deadline is set for 26 Sep 2026 when the IVDR EC contract already needs to be signed between the Notified Body and the manufacturer. 

How can SGS Fimko Oy (CE 0598) help you? 

We are welcoming applications to begin your journey towards IVDR compliant devices. SGS Fimko Oy is your reliable Nordic partner with high efficiency and focus on high customer satisfaction. Our IVDR scope can be viewed from the Nando database (EUROPA – European Commission – Growth – Regulatory policy - SMCS). 

You may want to visit our webpages (CE Marking for In Vitro Diagnostic Medical Devices (IVD) | SGS Finland) for general information about IVDR Certification process.You are welcome to contact us via our webpages or by sending email to IVD.devices.fimko@sgs.com to get the wheels rolling for you towards the EU market.