The European Notified Body, a partner of GRC Certification Institute,
Revised on April 5, 2017 for in vitro diagnostic medical devices
EU Regulation IVDR 2017/746 of the European Parliament and of the Council
We provide services as a certification authority.
According to IVDR 2017/746,
We conduct conformity assessments independently, impartially and objectively.
EU market launch
To bring devices to EU / EEA market
To place an in vitro diagnostic medical device on the EU market:
The device must comply with EU regulations.
Before a device is released to the market, a legitimate manufacturer must ensure that it meets relevant safety and performance requirements.
The CE mark must be affixed.
Affixing the CE marking is in compliance with regulations,
The correct conformity assessment pathway must be utilized, which in most cases will require the involvement of a certification body.
Devices requiring conformity assessment
Devices requiring notified body conformity assessment and EU certificate
The following devices require conformity assessment and EU certification from a notified body:
Class D
Class C
Class B
Class A sterile
For device classification and proper conformance assessment path.
Consult with GRC Certification Center.
IVDR Transition Schedule
IVDR compliance from 26 May 2022
All new in vitro diagnostic medical devices: Devices for which an EU Declaration of Conformity (DoC) has not been signed before 26 May 2022
Any device that has had a significant change after May 26, 2022
All Class A devices
QMS IVDR compliance by 26 May 2025
Regardless of the risk class of the device, all manufacturers of in vitro diagnostic medical devices must comply with the requirements by May 26, 2025.
According to Article 10(8) of the IVDR, a quality management system must be established.
This applies to all legacy devices that only comply with IVDD 98/79/EC.
All new devices placed on the EU market must be IVDR compliant.
Deadline for applications submitted to NB
Class D (May 26, 2025): 4 months to contract
Class C (May 26, 2026): 4 months to contract
Class B (May 26, 2027): 4 months to contract
Class A Sterilization (May 26, 2027): 4 months to contract
COM(2024)43 - To take advantage of the extension of the transition period, in accordance with the amendments to Regulation (EU) 2017/745 and (EU) 2017/746
Manufacturers must:
NB Selection, Application Submission and Contract Signing: Please note that the quotation phase is different from the review phase.
Continued compliance with IVDD 98/79/EC is required.
No significant changes should be made to the device design or intended use for IVDD compliance.
IVDR requirements relating to post-market surveillance, market surveillance, vigilance, economic operators and device registration must continue to be met.
New deadline
December 31, 2027 - Class D devices and devices with IVDD certificates
The new deadline only applies to those who signed a contract with NB and submitted their application by May 26, 2025.
December 31, 2028 - Class C devices
The new deadline only applies to those who signed a contract with NB and submitted their application by May 26, 2026.
December 31, 2029 - Class B devices
The new deadline only applies to those who signed a contract with NB and submitted their application by May 26, 2027.
December 31, 2029 - Class A (Sterile)
The new deadline only applies to contracts with NB and applications submitted by May 26, 2027.
