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In-vitro Device Regulation (EU) 2017/746

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In-vitro Device

IVDR 2017/746

In-vitro Device Regulation 2017/746

Conformity assessment services under IVDR are available

from the Notified Body, the partner of GRC Certification.

Currently we have capacity to take new custoemrs

and initiate conformity assessment service in a timely manner.

Competence of our personnel is reflected in our wide scope of designation,

covering IVR0300-IVR0800 codes and horizontal codes without

restrictions. As of today the growing team of our partner 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.

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Conformity Assessment

Conformity Assessment

the Notified Body, the partner of GRC Certification, 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.

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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 NB conformity assessment

and EU certificate

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.

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IVDR transitional timelines

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

QMS 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.

Application submitted to NB latest by: 

  • 26.5.2025 class D, + 4 months for contract

  • 26.5.2026 class C,  + 4 months for contract

  • 26.5.2027, class B,  + 4 months for contract

  • 26.5.2027 class A sterile + 4 months for contract

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

New timeline

  • 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

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