DEKRA Product Testing
Are you looking for an IVDR notified body? Submit your application now to DEKRA Certification B.V.
IVDR assessment by a notified body
Certification of in vitro diagnostic devices
Are you planning to place an in vitro diagnostic medical device on the market in the European Union (EU)? Then CE-marking demonstrating compliance with the In Vitro Diagnostic Regulation (IVDR) 2017/746 is required. You often need a notified body to assess whether your products comply. As a notified body, DEKRA Certification B.V. can assess whether your product complies with IVDR.
What is CE certification?
The CE (Conformité Européene) marking is the manufacturer’s declaration that a product fulfils relevant regulations and standards, including safety, health, and environmental protection requirements. All medical devices marketed within the borders of the European Economic Area must fulfil the requirements 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 do 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. This new regulation is already in force and will be mandatory for all IVD products after the established transition period.
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.
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?
- We have more than 25 years’ experience as a Notified body.
- Our experts have extensive knowledge and experience with medical devices for in vitro diagnostic use. DEKRA Certification B.V. has been designated for the IVDD for many years and is now designated for the IVDR.
- You can choose from two DEKRA notified Bodies for IVDR:
• DEKRA Certification B.V. in Arnhem, Netherlands (NB 0344)
• DEKRA Certification GmbH in Stuttgart, Germany (NB 0124) - DEKRA Certification B.V. is able to offer services for manufacturers globally. The Dutch notified body has offices in the UK, US, Israel, China and Japan.
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.