NOTIFIED BODY EU 2017/746 IVDR
Sertio is a notified body under EU IVDR
Conformity assessment services under IVDR are available from us.
Currently we have capacity to take customers.
Competence of our personnel is reflected in our wide scope of designation, covering IVR0300-IVR0800 codes and almost all horizontal codes without restrictions. As of today the growing team of Sertio has extensive amount of IVD work experience and IVD notified body experience in conformity assessment. As we focus exclusively on IVD medical devices we can fully utilize the considerable experience in the IVD medical device industry and prior notified body experience to customer benefit.
Sertio is based in Finland, serving customers globally.
We warmly welcome you as our customer. Kindly contact us for a quote:
See EU Commission NANDO web page (New Approach Notified and Designated Organisations ) for our scope of designation:
We provide Services as Notified Body for EU Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on In Vitro Diagnostic Medical Devices, as amended.
Notified bodies are independent, impartial and objective bodies carrying out conformity assessments under the IVD Regulation.
To bring devices to EU / EEA market, devices shall be in compliance with EU legislation
Before placing an in vitro diagnostic device on the EU market, the legal manufacturer must ensure that the device meets the relevant safety and performance requirements. IVD devices, must be CE marked before they are placed on the market. Prior to CE marking, correct conformity assessment route shall be utilized. Notified Body involvement is required in majority of conformity assessment routes.
Devices requiring notified body conformity assessment and EU certificate are:
- Class D
- Class C
- Class B
- Class A sterile
Classify your devices and determine the correct conformity assessment route. In case you need a notified body, we can deliver.
Kindly note that service is subject to availability.
IVDR transitional timelines
By the date below, devices need to be IVDR compliant. For class D devices, the time to act is now.
IVDR compliant since 26.5.2022
- All new IVD devices, in other words any device for which EU Declaration of Conformity (DoC) has not been signed before 26 May 2022.
- Any device to which significant changes have been made after 26 May 2022
- All class A devices
- Class D devices
- Devices with IVDD certificate
- Class C devices
- Class B devices
- Class A sterile devices