NOTIFIED BODY                       EU 2017/746 IVDR

Sertio has been designated as a notified body under EU IVDR!

We are grateful and appreciative to share that conformity assessment services under IVDR are now available from us.

Our notified body number is 3018.

Sertio is based in Finland, serving customers globally. 

We warmly welcome you as our customer. Kindly contact us for a quote:

Conformity assesment

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.