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IVDR assessment now mandatory: be on time with your application
Arrange your certification of in vitro diagnostic devices now
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​.
Deadlines by class
The Dutch government organization, the Health and Youth Care Inspectorate (IGJ), recently emphasized in this letter that it is indeed time to take action. This applies to you as well. The European legislator has recently introduced the following transition periods in the IVDR. The end date of the transition periods is linked to the risk class of the in vitro diagnostic:
- Until May 26, 2025, for Class D devices;
- Until May 26, 2026, for Class C devices;
- Until May 26, 2027, for Class B devices and for Class A devices placed on the market in a sterile condition.
To assist you in managing your transition in a timely manner, DEKRA has established deadlines for submitting your application for the different classes. Therefore, please note these dates in your calendar and initiate the application as soon as possible.
- No later than December 1, 2023, for Class D devices (expired);
- No later than December 1, 2024, for Class C devices;
- No later than December 1, 2025, for Class B devices and for Class A devices placed on the market in a sterile condition.
If these timelines are not met, we unfortunately cannot guarantee that the required assessments will be completed before your current IVDD certificates expire (or at the end of the transition period). Please be aware that this means you may not have a valid CE certificate for a certain period until certification under the IVDR is completed.
If you want to learn more about the mandatory CE marking for in vitro diagnostic products, what a notified body is exactly, and why DEKRA is the right partner for you, you can find answers to frequently asked questions below.
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 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.