NOTIFIED BODY EU 2017/746 IVDR

Sertio is a notified body under EU IVDR

Conformity assessment services under IVDR are available from us.

Sertio is based in Finland, serving customers globally.

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

IVDR transitional timelines

Manufacturer's QMS needs to be IVDR compliant by 26.5.2025

Regardless of the risk class of the device(s) by 26 May 2025, all manufacturers will have to put in place a quality management system in accordance with Article 10(8) IVDR. This is applicable to all legacy devices, compliant only with IVDD 98/79 EC. All new devices placed on the market in EU need to be compliant with IVDR already now.

In order to utilize transitional period (below) for legacy device, application must be submitted to NB latest by:

26.5.2025 for class D
26.5.2025 for devices with IVDD certificate

26.5.2026 class C

26.5.2027, class B

26.5.2027 class A sterile

Important note! in addition to application, a contract with notified body needs to be established, latest 4 months from application deadline (e.g. for class D device by 26.9.2025)

In order to utilize the transition time extension for legacy devices provided by COM(2024)43 - Regulation Amendment of Regulations (EU) 2017/745 and (EU) 2017/746 manufacturer shall

select a notified body, submit application to notified body and sign a contract with NB by the deadlines above within this chapter. Do note that quotation phase is different from application review phase.

continue to comply with IVDD 98/79 EC

not make significant changes to device design or intended use which is compliant with IVDD

continue to meet requirements of IVDR relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices

By latest the timelines below, only IVDR complying devices can be placed in EU single market:

31.12.2027, class D devices and devices with IVDD certificate

New timeline only with condition that contract with NB and application submitted by 26.5.2025

31.12.2028, class C

New timeline only with condition that contract with NB and application submitted by 26.5.2026

31.12.2029, class B

New timeline only with condition that contract with NB and application submitted by 26.5.2027

31.12.2029, class A sterile

New timeline only with condition that contract with NB and application submitted by 26.5.2027

REMINDER:

The following devices have had to be 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

Conformity assesment

See EU Commission NANDO web page (New Approach Notified and Designated Organisations ) for our scope of designation:

https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies

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.