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IVDR notified body
DEKRA Product Testing

Do you want to certify your medical equipment to comply with relevant laws and regulations?

IVDR Notified Body mandatory assessment

Arrange your certification with a IVDR Notified Body

Do you want to introduce a medical in vitro diagnostic device to the European market? If so, a CE marking is required. The CE marking for in vitro diagnostic (IVD) products indicates compliance with the latest regulations, specifically the In Vitro Diagnostic Regulation (IVDR) 2017/746. Often, you will need an assessment from a notified body for this purpose. DEKRA Certification B.V. can act as a notified body to assess whether your product meets the requirements of the IVDR. Tip: initiate your CE marking application for your device under the IVDR well in advance.

Is your in vitro diagnostic product classified as Class A sterile, B, C, or D? And do you intend to enter the European market with it? Then you are now obligated to engage a notified body for the certification of your product. The new regulation, In Vitro Diagnostic Regulation (IVDR) 2017/746, has been in effect since last year and is mandatory for all IVD products after the specified transition period​.

Please note: New extension of the IVDR

Transitional Periods (Amendment EU 2024/1860)

The regulation (EU) 2024/1860, amending IVDR 2017/746, was published on the 9th of July 2024. A key topic of the amendment is the extension of the IVDR transitional periods. In addition, the European Union has also published a related Q&A document. Please note it is important to read the full text of the amendment and related Q&A document to understand the full implications.
With the new amendment, the dates until which devices certified under the IVDD can be placed on the market or put into service has been extended. The extension time depends on the presence of an IVDD certificate, or in case of self-declared IVDD devices, the IVDR classification of the device.
To be able to make use of the extension, several conditions should be met. The information below will provide an overview of these conditions and the timelines.

Conditions to be met by manufacturer

In order to make use of the extension, the following conditions should be met by the manufacturer:

Timelines per situation

    Devices with an IVDD certificate (situation 1)
    To be able to make use of the extension for a device with an IVDD certificate (Annex II List A, List B and self-tests) the IVDD certificate should:
    • be issued from 25 May 2017;
    • still be valid on 26 May 2022;
    • not have been withdrawn.
    If the certificate of the device was still valid on 09 July 2024, and the conditions for the manufacturer are met (see above), the device can be placed on the market or put into service until 31 December 2027
    If the device's certificate expired on July 9, 2024, the device can still benefit from the IVDR extension if at least one of the following conditions is met:
    The application has been submitted and a written agreement was concluded between the manufacturer and the Notified Body for the device or substitute device, before the expiry of the IVDD certificate.
    The competent authority has issued a derogation for the device according IVDR article 54(1).
    The competent authority has required the manufacturer in accordance with IVDR Article 92(1), to carry out the applicable conformity assessment.
    If the conditions for the manufacturer are met (see above), the device can be placed on the market or put into service until 31 December 2027.
    Continuation of supervision
    Surveillance of devices with an IVDD certificate must be continued during the transition period.
    A manufacturer may change Notified Body when transferring from IVDD to IVDR. Initially, the Notified Body that issued the IVDD certificate will remain responsible for the surveillance of that device, unless the surveillance activities can already be performed by the Notified Body performing the IVDR assessment, when agreed by the manufacturer and incoming IVDR Notified Body. The exact transition could be determined in a tri-partite agreement. However, the notified body performing the IVDR assessment should not become responsible for the surveillance later than 26 September 2025.

    What is CE certification for medical devices?

    The CE (Conformité Européene) marking is the manufacturer’s declaration that a product fulfils relevant regulations and standards. These regulations and standards include safety, health, and environmental protection requirements. All medical devices marketed within the borders of the European Economic Area must fulfil the requirements that are set out in the IVDR or Medical Device Regulation (MDR).

    What is a notified body?

    A notified body is an organization authorized to assess the conformity of certain products before they are placed on the market. Usually, the competent authority appoints notified bodies. DEKRA is authorized as a notified body to assess the conformity of medical products, according to the regulations as described in the IVDR and MDR.

    When you need to use a notified body to obtain CE IVDR certification?

    Does your in vitro diagnostics fall into class A sterile, B, C or D of the IVDR? Then it is mandatory to have your products certified via a notified body if you wish to access the European market.

    What are the next steps for an IVDR assessment?

    Are you interested in inquiring about conformity assessment against the IVDR 2017/746? Submit an application to DEKRA Certification B.V. Should it be confirmed that DEKRA can offer the required IVDR services, you will than receive a quotation. The core activities to assess your products conformity with IVDR requirements entail:
    • an off-site review of the technical dossier(s);
    • an on-site Quality Management System (QMS) audit.
    If the review and the audits have satisfactory results, the CE certificates will be issued. Please note that this process from receiving a quotation until CE certification can take time; 1,5 years is no exception. The lead time highly depends on the quality of your Technical Documentation and Quality Management System and relies on you providing sufficient evidence of conformity.

    Does your device contain an electrical component or wireless connection?

    In that case, your product must first be tested for safety aspects. For example, on electrical safety, electro-magnetic compatibility (EMC) or wireless technologies. Testing is done by an accredited test laboratory, such as DEKRA Product Testing. The tests and any associated certificates are part of the notified body's assessment process. DEKRA notified body accepts tests and certificates from DEKRA Product Testing, or from another accredited testing laboratory. Read more about testing medical devices by DEKRA Product Testing here​.
    Why choose DEKRA as your IVDR Notified Body?

    Why submit your application for IVDR certification now?

    If you need a notified body to assess your conformity against the IVDR 2017/746, make sure you submit your request on-time. The notified body flexibility for scheduling reviews and audits is limited, due to the high workload of the EU IVDR transition.

    Start your request

    Request a quote now or a meeting with one of our experts. During this session, you will have the time to discuss your business case and ask all your questions to our expert. Simply fill out the form below and we will contact you to set up a meeting as soon as possible.